WO2013115759A1

WO2013115759A1 - Topical medications for controlling epidermal symptoms

Info

Publication number: WO2013115759A1
Application number: PCT/US2012/000226
Authority: WO
Inventors: Branimir L. Horvat; Nevenka Horvat; Michael I. PASS
Original assignee: Horvat Branimir L; Nevenka Horvat; Pass Michael I
Priority date: 2012-02-01
Filing date: 2012-04-30
Publication date: 2013-08-08

Abstract

A method for treating epidermal symptoms of a variety of skin diseases from Eczema to Psoriasis, Rosacea, etc. The proposed creams and lotions treat the epidermal symptoms in four to five days or, in more severe skin symptoms, in two to three weeks. The topical medications are composed of Aloe Vera, vanishing cream, water and different concentrations of Salicylic Acid and certain glucocorticoids. For the proper action of the medications, Salicylic Acid and glucocorticoids have to be dispersed in extremely small micelles in the emulsions of the creams and lotions. Some strengths of the medications may be sold over-the-counter (OTC), while some will require physicians' prescription.

Description

Topical Medications for Controlling Epidermal Symptoms

SUMMARY

A method for treating epidermal symptoms of a variety of skin diseases from Eczema to Psoriasis, Rosacea, etc. The proposed creams and lotions treat the epidermal symptoms in four to five days or, in more severe skin diseases, in two to three weeks. The topical medications are composed of Aloe Vera, vanishing cream, water and different concentrations of Salicylic Acid and certain glucocorticoids dispersed in the form of extremely small micelles. Some strengths of the medications may be sold over-the-counter (OTC), while some will require physicians' prescription.

Photographs:

Photographs 1. And 2. These photographs exhibit the appearance of the skin of a young boy with Contact Dermatitis. Numerous red and elevated lesions are apparent on the left and right side skin of his abdomen.

Photographs 3. and 4. Appearance of the skin after four days of treatment with our cream.

Photographs 5., 6. and 7. These photographs illustrate the skin of the leg of a young woman with Eczema previously treated unsuccessfully. Notice the dry and scaly lesions of her skin.

Photographs 8., 9., 10., and 11. These photographs were taken after fifteen days of treatment with our creams. All previously involved areas are completely normal. Topical Medications for Controlling Epidermal Symptoms

Photographs 12. through 15. This young boy has been experiencing widespread skin involvement due to his Eczematoid Neurodermatitis. Picture #12. is of his severely inflamed neck, #13. flexor areas of his legs, #14. of his left shoulder, #15. of the left side of his back. He was treated by many physicians before without positive results.

Photographs 16. through 19. illustrate the patient's appearance after fifteen days of treatment. With the exception of his neck which showed some residual scarring, the remaining photographs exhibit normal skin of the areas which were previously involved. Photographs 20. through 23. The same patient seen in photographs 12. through 15. and 16. through 19., came six weeks later with recurrence of his skin symptoms on the back (20.,), flexor side of his legs (21.) and his ankles (22. and 23.).

Photographs 24. through 27. The same areas are shown after four days of treatment with our creams. All skin symptoms were essentially resolved. Photograph 24. exhibits the back of the aforementioned patient ten days after treatment was stopped. The skin appears completely normal.

Photographs 28. through 30. The same patient came again five weeks later with recurrence of his symptoms. He shows involvement of the skin of the face (#28), back (#29) and frontal part of his abdomen (#30).

Photographs 31. through 33. This same patient was treated for four days and skin of the face is totally normal (#31.) and the skin of the frontal part of his abdomen is without any abnormality (#32.) and his back is now clear (#33.). He did not receive any more treatment for this recurrence.

Photographs 34. and 35. This patient came sixteen weeks after the resolution of his Topical Medications for Controlling Epidermal Symptoms last symptoms. He presented with the scaly symptoms and erythema of his scalp (#34) and the back of his ear (#35.).

Photographs 36. and 37. The appearance of the patient's scalp (#36.) treated with our lotion and ear (#37) treated with our cream after seven days of treatment.

Photographs 38. through 41. The appearance of the same patient two months after the resolution of his previous symptoms. The patient was not treated after the initial seven days of treatment.

Photographs 42. through 43. This patient exhibited skin symptoms on her left hand. She suffered from Eczematoid Neurodermatitis. She had been treated previously by numerous physicians without any results.

Photograph 44. Appearance of the hand after eight days of treatment.

Photograph 45. Patient with Eczema of the left fourth finger. The patient was seen in the past by numerous physicians without any significant improvement.

Photograph 46. Appearance of the finger seven days after treatment. No treatment was administered after first three days.

Photograph 47. The same patient experienced a recurrence of Eczema five weeks after the resolution of his initial symptoms.

Photograph 48. Appearance of the finger seven days later with no treatment after the initial four days.

Photographs 49. through 52. Patient with Solar keratoses of his left shoulder (#49.), back (50.), right side of his abdomen (51.) and lower arms (52.).

Photographs 53. through 56. Appearance of the skin after twelve days of treatment Topical Medications for Controlling Epidermal Symptoms of left shoulder (#53.), back (#54.), right side of the abdomen (#55.) and lower arms (#56.).

Photographs 57. through 64. Appearance of the patient with fulminant Psoriasis Vulgaris. The pictures show the back of his neck (#57.), left arm (#58.), upper head (59.) and lateral side of his face (#60.), frontal side of his neck (#61.), left ear (#62.), chest (#63.) and his back (#64.).

Photographs 65. through 72. Appearance of the patient's skin and scalp after fifteen days of treatment. The skin was treated with our cream and the scalp with our lotion.

Photograph 73. The same patient showed recurrence of the scalp symptoms after two years without any symptoms.

Photograph 74. The same patient after seven days of treatment with our lotion. The scalp symptoms are completely resolved.

Photographs 75 and 76. Patient with Rosacea treated unsuccessfully by numerous physicians.

Photographs 77. and 78. Appearance of the same patient four months later. However, patient was treated for only ten days. Topical Medications for Controlling Epidermal Symptoms

Topical Medications for Controlling Epidermal Symptoms

Topical Medications for Controlling Epidermal Symptoms

Topical Medications for Controlling Epidermal Symptoms

Topical Medications for Controlling Epidermal Symptoms

Topical Medications for Controlling Epidermal Symptoms

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Topical Medications for Controlling Epidermal Symptoms

Topical Medications for Controlling Epidermal Symptoms

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Topical Medications for Controlling Epidermal Symptoms

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Topical Medications for Controlling Epidermal Symptoms

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Topical Medications for Controlling Epidermal Symptoms INTRODUCTION

Over one third of the US population suffers from skin symptoms caused by Eczema, Psoriasis, Parapsoriasis, Solar Keratoses and Rosacea, and other skin conditions. In addition to their skin symptoms, many patients also have other generalized and focal organ involvements.

The diseases mentioned above are caused by many diverse pathophysiologic conditions many of which are unknown. The medications described in this patent do not address the etiology of these various diseases and do not cure these conditions but provide temporary relief of the epidermal symptoms of the patients. We do not claim that our medications address either generalized or specific presentations or symptoms in other organs. It is important to understand this limitation of the proposed medications and their use. The proposed creams and lotions will give patients suffering from these conditions periods of symptomatic relief of their epidermal symptoms more effectively than other currently available products. Photographic examples of patients treated with the proposed medications are presented in this patent application and show that some of the patients had several recurrences of skin symptoms.

Pathophysiology of the patients' diseases determine the length span of time that may elapse between the elimination of epidermal skin symptoms and their recurrence. Most of the time we do not know the reasons for these recurrences. It is our estimate that patients with conditions that may be affected by our medications may require two or more Topical Medications for Controlling Epidermal Symptoms applications per year to control their epidermal symptoms. Because their discomfort and the appearance of their skin severely limits their normal life activities, the effective and convenient treatments possible with this medication will provide them with a significantly improved quality of life. Additionally, treatment of the epidermal symptoms may improve patients' ability to keep gainful employment and maintain relatively normal life activities.

Present topical, oral, or injectable medications do not resolve the epidermal symptoms very effectively. The medications we are proposing consist of several specific modifications of creams and lotions for treatment of the patients' epidermis. Affected patients may have different clinical presentations of skin symptoms caused by various medical conditions which may sometimes be exacerbated by additional problems. These conditions range from Eczematous ailments to Psoriasis, Rosacea and various parapsoriatic conditions. Additionally, these patients' skins may be affected with bacterial, fungal and viral infections. When these infections are diagnosed and identified, additional medications may be added to our creams and lotions for treatment. However, these infections may also be treated separately from our proposed creams and lotions.

Production of our creams and lotions is fairly inexpensive. The compounds used do not require long and elaborate testing because they have been previously used in other medications for a long time. We have prepared and composed these compounds in a very specific way to achieve the results we obtained. Thus, approval for wide use of our medications will not require a long waiting period and will not be very expensive. Topical Medications for Controlling Epidermal Symptoms

Thus, approval for wide use of our medications will not require a long waiting period and will not be very expensive.

Epidermal symptoms in most of the aforementioned diseases usually recur and require additional treatment. This is the case with the present modalities of treatments and our proposed creams and lotions are no exception. Most of the more efficient presently used creams and lotions require physicians' prescriptions. Some ailments are also presently treated with injectable medications. These injections are not always enthusiastically accepted by patients. Some of our topical creams and lotions will require physicians' prescriptions while some can be sold over-the-counter (OTC).

REVIEW OF THE PRIOR ART

A search of existing patents did not reveal any applications or approved patents proposing a similar type of medication as is proposed by this patent for resolving the epidermal symptoms we addressed. Almost all patents that addressed treatments of skin diseases did not address the duration of the necessary treatments, frequency of the applications or the Method by which the medications were prepared.

The first patent we found is "Method of Treating Acne Vulgaris and Composition" by Joel Bernstein (US Patent 4,505, 896) submitted in December 1995. This patent deals with a combination of several oral medications (nicotinic acid or nicotinamide) and topical solutions of similar compounds dissolved in various organic vehicles (not specifically identified) combined with several substances (sulfur, benzoyl peroxide, Topical Medications for Controlling Epidermal Symptoms vitamin A, erythromycin, clindamycin, and tetracycline) as well as Salicylic Acids. The author did not present any information regarding the efficacy of the treatments with these methods, the durations of necessary treatments, or specific end results of such treatments.

The second patent reviewed was "Formulations and Methods for Reducing Skin Irritation" by Gary S. Hahn and David O. Tueson (US Patent 6,455,076 B1). This patent deals generally with decreasing irritation and consists of various skin preparations used for a number of different reasons. The authors used different cations to increase the pH of the skin preparations to decrease irritation to the patients' skins. Upon reviewing this paper, we examined the responses of our patients to the application of our creams and lotions and did not find any complaints. Patients stated that they knew that cream or lotion was applied but they did not feel discomfort. We were concerned with application of cations in the creams and lotions because they could chemically react with active components and diminish the efficacy of such active components of the medications by chemically altering them.

The third patent reviewed was "Method and Composition for treating Psoriasis, Eczema, Seborrhea and Arthritis" by Steven A. Smith (US Patent 6,613,800 B1). It dealt with an oral treatment consisting of a mixture of three primary active ingredients: fumaric acid, inorganic nickel compound and inorganic bromide compound. Patients presented in that patent were treated from one to several months and exhibited good but often incomplete recovery from their symptoms. We did not see results obtained in of the Psoriatic patients, and resolutions of the skin symptoms were not very impressive Topical Medications for Controlling Epidermal Symptoms compared with our results. In addition to the above, the patent did not contain any study on the toxicity of the inorganic nickel compound and inorganic bromide compound. This should have been addressed when the patent was submitted.

The fourth patent, "Cosmetic, Personal Care, Cleaning Agent, and Nutritional Supplement Compositions and Method of Making and Using Same" by Sean Lee et al. (US Patent 7,250,174 B2) deals with the use of bioactive glass in various skin preparations, from cosmetic to biocidal agents. We do not have any proficiency in this area. We did not use this substance and have no opinion regarding that patent. The patent essentially describes a basic cream that may be used in number of specific applications as the authors suggested.

The fifth reviewed patent, "Method of Treating Dyshidrosis (Pompholyx) and Related Skin Disorders" by Elizabeth Anne Mazzio and Karam F. Soliman (US Patent 7,666,451 B2) deals with specific treatment of the Dyshidrosis (Pompholyx) and other diseases of the skin. The authors use oral administration of niacin combined with topical administration of several plant extracts. They also suggest incorporation of antibiotic and antifungal components and state the duration of treatment for only one patient. We did not use any of their selected components for treating our patients.

The sixth reviewed patent, Dermatological Compositions and Methods by Gloria A. Rood et al. (US Patent 8,013,017 B2) is an interesting patent dealing with basic dermatologic topical preparations for use in a variety of different medications ranging from simple soothing skin preparations to medications with antimicrobial, antiviral, antifungal and anti-neoplastic uses. The authors propose numerous compositions, Topical Medications for Controlling Epidermal Symptoms using various salts and active chemical additives. While this patent will be used in composing various future topical dermatologic preparations, we did not find anything with direct correlation with our proposed medications.

AREAS OF SKIN PATHOLOGY ADDRESSED IN OUR RESEARCH

In our research, we limited ourselves to specifically target epidermal symptoms. We did not devise permanent cures for the underlying conditions as mentioned in the introduction. We are aware that numerous institutions work to devise such permanent cures and we hope that the definitive curative medications will be discovered by the scientists working on these problems. However, before now, there were no medications able to quickly and effectively address the epidermal presentations of many of these conditions. In this section we will address the specific problems we set out to resolve.

The proposed creams and lotions contain substances that will promote the necessary moisture of the skin, prepare the dermis to accept the newly grown epidermis, desquamate the damaged epidermis, and promote the growth of the new healthy epidermis. Bacterial, fungal and viral inflammations may need to be treated in addition to the treatments of the damaged epidermis.

Many of the affected skin diseases have a common symptom of damaged integrity of the epidermis, which causes most of the patients' subjective clinical problems. These symptoms are most commonly the ones with which the patients are predominantly concerned. These symptoms involving the epidermis are the Topical Medications for Controlling Epidermal Symptoms predominant reason patients seek medical attention. The morphological appearance of their skin is typically the reason for their inability to function in their normal lives and keep employment.

The first problem we addressed was maintaining the moisture level of the skin, which must be addressed if any medication will be successful. Damaged skin commonly exhibits drying of the skin surfaces due to nonspecific inflammation and specific infections damaging the skin. Dry epidermis has a tendency to crack, resulting in further loss of integrity of the epidermal surface. Outside irritants, allergens and noxious substances cause damage to the underlying skin layers, further damaging the weakened epidermis as well as the skin layers under it. This also exposes the damaged areas to the specific bacterial, fungal or viral infections. The medications we use have to be emulsified as very finely dispersed micelles in the aqueous milieu to act positively on skin symptoms. We have found several substances that are effective in the resolution of such problems. Due to common problems with dry skin, we always suggest that patients use a good, commercially available moisturizing cream after we finish treating their skin symptoms.

During the research phase, many substances were considered that primarily affect the epidermis. Some of these substances desquamate the epidermis and others promote the growth of the epidermis. We looked for substances that would desquamate the epidermis in certain concentrations and promote its re-growth in other concentrations. Unfortunately, there are not many substances meeting these criteria. Some such substances also have noticeable undesirable or negative effects. Topical Medications for Controlling Epidermal Symptoms

The other problem in addressing epidermal skin symptoms is the inflammatory effect that negates the effect of the first class of substances. External substances such as irritants, allergens and infections result in damage to the sub-epidermal areas of the skin. This causes either nonspecific or specific inflammatory presentations of the affected skin. Most of these specific and nonspecific inflammatory effects are the result of the interruption of the integrity of the epidermis, which has an inflammatory effect on the underlying sub-epidermal layers of the skin. At the present time the substances used to deal with nonspecific inflammatory conditions of the skin are various corticoid medications. However, when corticoid medications are used as the only method of treating the skin, they offer only a very temporary relief to the patients because they do not cause re- epithelialization of the interrupted and damaged skin from the surrounding normal epidermal surfaces.

The next issues are various concurrent infections of the skin due to the interrupted integrity of the epidermis as well as a decrease of the basic immunologic resistance of the skin due to the loss of the epidermal integrity and the underlying primary diseases. These underlying primary causes of the skin diseases damage the epidermis and decrease the patients' general immunity. These factors allow infections to start and progress. Bacterial, fungal and viral infections also have to be addressed while the epidermis is being repaired. Clinical signs, cytologic manifestations and cultures of the surface of the skin are used to diagnose the presence of such additional problems. These conditions have to be properly addressed in affected patients.

Additionally, a patient may show shows symptoms of hypo-nutrition or other Topical Medications for Controlling Epidermal Symptoms debilitation. In less severe cases, additional substances like vitamins may be included in the proposed creams and lotions. In severe cases, patients may have to be systemically treated. For details, refer to the composition of various proposed creams and lotions in this paper. The prescribing physician must make a decision when examining the patient and determine the proper composition of the medication to be added for each patient.

Another problem we had to address was the ability of the substances in our medications to act together appropriately in healing epidermal afflictions of the skin diseases. Obviously the creams have to be appropriately compounded into workable medications so that each part acts in its specific way and allows the rest of the medication to address the symptoms, thus resolving them as a group. We noticed that if the Salicylic Acid and glucocorticoids were not dispersed in the creams and lotions in the form of extremely small micelles, the medications were not as effective.

Here we present these substances separately in the order in which they function in repairing damaged skins. We will discuss them as separate problems we had to address.

1. Dryness of the skin caused by various conditions disrupting the integrity of the epidermis.

One of the first and most important parts of repairing the damaged skin is solving the problem of skin dryness. Dryness of the skin is commonly associated with skin diseases and affected the patients we treated. This dryness causes the epidermis to crack and exposes sub-epidermal areas to substances that irritate the skin. It also Topical Medications for Controlling Epidermal Symptoms allows irritants, allergens and infectious agents to cause further damage to the skin. We addressed this problem at the initiation of the treatments and after we finished the treatments.

We also had to address the problem of incorporating the substances we planned to use as medications and dispersing the medications to act in an aqueous milieu. The active medications had to be usable in workable concentrations in the aqueous milieu to be effective, whether they were dissolved or functioned as minute globules (micelles) emulsified in the aqueous milieu.

As we will present in the further text we found that Aloe Vera cream was one of the ideal substances for that purpose and we were able to use it to moisturize the patients' skins. The active medications were also incorporated into the Aloe Vera and commercially available vanishing cream. Other moisturizing agents could be used for this purpose. As stated previously, we always suggest that patients use a good commercial moisturizing cream after we finish treating their skin symptoms and they develop normal skin.

2. Compounding various substances to act as workable medications.

In conjunction with resolving the issue of skin dryness, we had to compound the various active substances to act as workable medications. We were lucky that we had available a cooperating compounding pharmacists with experience in compounding various medications to create effective formulations. The two most important active substances are Salicylic Acid and corticoid medications. They are non-soluble and must be dispersed as very fine globules (micelles) in the basic emulsion. They were Topical Medications for Controlling Epidermal Symptoms emulsified in the creams and lotions individually and in the form of extremely small micelles. This way, these two active components are present in separate micelles containing only one active substance each. These two substances could also be simultaneously emulsified in the cream or lotion.

In addition to these active and supportive components of our creams and lotions, several high quality routine components were added. Our trials exhibited excellent results as presented in the pictorial part of the patent. The further text of the patent presents a partial list of different possible creams and lotions.

In addition to Aloe Vera, we use a commercially available vanishing cream with the following formula:

Base: Vanishing cream/lotion formula (anhydrous) 23%

Xanthan gum 1 %

Water (Purified) 75.65 %

Sorbic Acid 0.1%

Krisgel 100 0.25%

The vanishing cream contains varying amounts of purified water. The entire composite is placed in an EMP (electronic mortor pastle) resulting in extremely fine emulsified creams and lotions containing effective medication. These finely emulsified creams and lotions provide us with a medication that exhibits surprisingly effective treatment of skin symptoms in patients with a variety of skin conditions. In short, the active substances we selected work together during the therapeutic application. The Topical Medications for Controlling Epidermal Symptoms pharmacodynamics of the creams and lotions are presented in the later text.

The creams and lotions have several similarities and differences. Creams may be oil-in-water or water-in-oil. Our creams are oil-in-water. They are soft-solid and contain active substances to be applied externally for therapeutic purposes.

The lotions are mainly aqueous. The main difference between the creams and lotions is that lotions are less viscous, meaning the medium meets with less resistance, allowing the patient to spread it thinly over larger areas than is possible with a cream. The lotions contain insoluble materials in the form of suspension or emulsion intended for external application without excessive rubbing. Lotions usually have soothing, cleansing, and antiseptic properties.

Another problem that had to be resolved was the irritation of the damaged skin from the micelles of Salicylic Acid. The pH of the creams and lotions ranges from 2.9 to 3.1. Our creams containing micelles of Salicylic Acid in a concentration ranging from 3% to 10% did not cause unpleasant reactions for our patients. As a result we did not encounter any resistance from our patients when they were instructed to use our creams or lotions for treatment of their epidermal symptoms.

A small concentration of Thymol Crystals for preservation of the creams under room temperature (usually 0.02 grams per 100 grams of cream) was also added.

At this point the addition of active substances will be described according to the specific areas of each substance's action.

3. Nonspecific Inflammatory effect on the skin.

The nonspecific inflammatory symptoms of the skin are due to the exposure of Topical Medications for Controlling Epidermal Symptoms the subepidermal areas of the skin to outside irritants or allergens because of the lack of epidermal integrity. This is also due to a general decrease of the patients' immunity because of their primary diseases.

We considered a number of substances used for suppression of nonspecific inflammatory conditions of skin. The best known are various corticoid preparations used for this purpose for many years. We have decided to use them in our medications because they appear to be the most widely tested for that purpose.

Additionally, These corticoids may be used in prescription strength or in strengths suitable to be sold for over-the-counter (OTC) use. Because we were dealing with different levels of presentations of nonspecific skin inflammations, we decided to use both of these groups of corticoid medications rather than experiment with other, less tested compounds.

For the over-the counter (OTC) medications, we used up to one percent of Hydrocortisone Mic powder 99.34 in our creams and lotions. Other such glucocorticoids may also be used. In the creams for more severe cases requiring prescription medications, we used Triamcinolone Acetonide micronized powder. However, other cortisone medications may be used for making these creams and lotions. More potent medications may require prescription and other less potent medications could be incorporated in the OTC medications.

Glucocorticoids were incorporated in the creams and lotions as separate micelles in the emulsions. Topical Medications for Controlling Epidermal Symptoms

4. Secondary infections of the skin.

Skins of patients with different dermatologic ailments are often affected by secondary bacterial, fungal or viral infections. The skin, which is weakened by the lack of a protective epidermis and decreased immunity due to the patient's primary disease, allows bacteria, fungi and viruses to attack the skins of these patients.

Fortunately, there are a variety of antibiotics, antifungal and antiviral medications to fight such skin infections. The only difficulty lies in incorporating such substances adequately so that these medications are in concentrations that may cure the infections while our medications re-grow the skin and make it more resistant to infection. Obviously, physicians always have the choice to treat the patients' skin infections separately from incorporating such agents in the creams and lotions.

5. Substances that desquamate the damaged epidermis and promote the growth of new layers of the epidermis when applied in specific concentrations.

During our research, we considered several substances able to desquamate and re-grow the epidermis and finally focused on the rather simple chemical component known as Salicylic Acid. Salicylic Acid acts as a desquamative agent at certain higher concentrations and promotes the growth of the epidermis in lower concentrations.

We initially tried the Salicylic Acid in higher concentrations, which resulted only in a desquamative effect. A decreased concentration of Salicylic Acid was used next and we noticed that these lower concentrations, in addition to having a desquamative effect on the damaged areas of the epidermis, also caused re-growth of the skin from the surrounding normal areas of the skin. Both of these actions were mentioned in older Topical Medications for Controlling Epidermal Symptoms

Pharmacopeias, but were not widely considered in recent medications or scientific papers. We used mixtures of the creams and lotions containing Salicylic Acid in marginal concentrations (ranging from 3% to 10%) between its exhibition of desquamative properties and re-growing properties. These concentrations were best for repairing the patients' epidermal symptoms. When these concentrations were used, they acted in two ways. When damaged epidermal cells were exposed to concentrations below the usual desquamative level for the normal healthy epidermis, the damaged epidermis was desquamated. The areas of the unaffected epidermis containing healthy basilar epidermal cells re-grew to cover the damaged areas of the sub-epidermis where the skin was already desquamated. The inflammatory effects were ameliorated with the glucocorticoids. This was the method used to repair the damaged epidermis assuring that the damaged areas were first desquamated and then covered by epidermal cells from the surrounding normal epidermis. This new epidermis provided continuity of the epidermal layer of the skin and thus protected the immediate subepidermal areas of the skin against negative outside influences. The application of our creams and lotions caused this new epidermis to reach normal thickness in a very short period of time (see photographs of the treated patients). Thus, the new skin was able to protect patients from irritative, allergic and infectious agents.

However, we noticed differences in reactions of patients from different age groups. Patients up to twelve years of age showed good responses when the concentration of Salicylic Acid was lower than the concentrations used in the medications for adult patients. Thus, we used concentrations of Salicylic Acid ranging Topical Medications for Controlling Epidermal Symptoms from three to five percent for pediatric patients. Patients above the age of twelve reacted better to concentrations above three percent, typically in the range of five to seven percent. In some adult patients we used an even higher concentration of Salicylic Acid, up to ten percent. However, some patients over the age of twelve responded well to concentrations of Salicylic Acid in the low range (from 3% to 5%).

When patients presented with scaly areas of the skin, they reacted better to concentrations of seven percent or higher. However, some adult patients with such symptoms reacted well even when the concentration of Salicylic Acid was in the five percentage level.

We used different concentrations of Salicylic Acid for different disease conditions. Our experience with ordinary Eczema was that these cases required lower concentrations of Salicylic Acid (from three percent to five percent) than necessary for patients with Psoriasis, Eczematoid Neurodermatitis, Solar Keratoses or Rosacea, who responded to concentrations of Salicylic Acid greater than five percent. They typically responded best to a concentration of Salicylic Acid in the seven percent range. Some patients required higher percentages, up to ten percent.

Lotions were usually prepared using higher concentrations than were used in creams for the same patients because of the scaly presentation of the patients' hairy areas. Proper further clinical Protocols will determine the upper ranges in such extreme cases.

The duration of treatment necessary to resolve epidermal symptoms also varied. Patients with ordinary Eczema, as well as some patients with less pronounced Topical Medications for Controlling Epidermal Symptoms symptoms in more severe diseases like Psoriasis, reacted well in five to seven days of treatment administered three times daily. More severe symptoms, particularly when scaly presentations occurred, required eight days to two or rarely three weeks of treatment. However, some patients' symptoms resolved in only a few days.

Our proposed creams and lotions work together in the following manner during therapeutic application:

a. Moisturize the affected area. The first action of our aqueous creams and lotions is to properly moisturize the dry skin as well as to serve as a medium for the compounded medication. We always suggest that patients use moisturizing creams after we finish treating their skin symptoms.

b. Decrease nonspecific inflammation of subepidermis. The glucocorticoids of the creams and lotions decrease nonspecific inflammation and prepare the subcutaneous area of the skin for re-growth of the new basilar epidermal cells from the surrounding unaffected skin after the desquamated cells are removed. Depending on the severity of the inflammatory changes of the sub-epidermal area of the skin, we use either strength of glucocorticoids suitable for use in OTC or prescription medication. When a specific inflammatory agent is diagnosed, the affected patient should be treated with the appropriately targeted medication, either systemically or topically. Both glucocorticoids and Salicylic Acid must be dispersed in the creams and lotions in the form of very fine micelles to be effective.

c. Desquamate the damaged epidermis. This action, progressing concur- Topical Medications for Controlling Epidermal Symptoms

rently with the previous actions, is desquamation of the sick or damaged areas of epidermis. For this, the appropriate concentration of Salicylic Acid must be used. Damaged epidermis may be desquamated with a lower concentration of Salicylic Acid than is necessary for the normal epidermis.

d. Induce the normal surrounding epithelium to re-grow and cover the desquamated areas. At this point the normal epithelium surrounding the desquamated areas re-grows and covers the areas where the damaged epithelium was desquamated and removed.

e. Thicken the re-grown new epithelium. During further treatment with our creams and lotions, the initial basilar epidermis covering the areas mentioned in point "d" develops into the full thickness of the normal epithelium of the epidermis and is able to protect the treated skin from undesirable outside damages. This stage of the repair lasts from three to six days.

f. The process is similar in several disease conditions. Due to the fact that our medications treat only the epidermis and the immediate subepidermal areas, the same process occurs in patients with different diseases.

g. The active medications are finely suspended in the basic creams and lotions. Aloe Vera and other adjuvants such as the vanishing cream consisting of Polysorbate 80 and Krisgel 100 are placed in EMP (electronic mortor pastle). This results in extremely fine emulsified creams and lotions containing appropriate concentrations of Salicylic Acid and glucocorticoids in the form of Topical Medications for Controlling Epidermal Symptoms extremely small micelles. These simple compositions gave us results that have not been achieved previously by other medications for these skin diseases. They allow us to achieve proper skin moisturization and proper dispersion of our active substances.

ADDITIONAL COMMENTS

During the initial trials of our creams and lotions, we noticed that we had two distinct groups of patients with very different responses to our medications. One group responded very well and the other displayed some improvement, but not as much as the first group. We were puzzled by this difference in responses to our treatment. Both groups reported feeling significantly better than they did prior to our treatments. According to their own statements, most of the patients we treated saw several other physicians previously without satisfactory results.

When we evaluated these responses, we found that the first group of patients, who experienced a very good response, applied our creams three times daily or more. Those who applied the medication more than we suggested did not exhibit results significantly better than those using the medication as suggested. The latter group felt that if three times daily was good, more than that should be better. As a result, we insisted that they follow our instructions exactly.

Upon detailed examination and questioning of the members of the less responsive group, it was discovered that they felt their symptoms were diminished. Topical Medications for Controlling Epidermal Symptoms

Once they felt better, they either did not apply the medications as suggested or stopped using them all together. Even when we explained the pharmacologic necessity of administering the creams and lotions as prescribed, some patients were not following our directions precisely.

To prevent these non-optimal results, we mandated that patients had to be seen in our office once a day and apply the medication two more times at home during the first week. After this modification of our approach, we had no patients who did not respond as expected to the treatment. When we saw that the skin adequately re- epithelialized the affected areas, we stopped further use of the medications. Our experience is that the creams and lotions have to be applied for an additional three to five days after initial symptoms are resolved to reach full re-epithelization of the affected area.

As stated previously, some patients did not have recurrences of their skin symptoms for several months to two years and some had recurrences a few weeks or months after the initial treatments. Patients with recurrences are shown in pictures #22. through #25, #30. through #32., #38. and ##39., #49., and #74. The results of the treatments with our creams and lotions are shown for these patients in pictures #26. through 29., #33. through #35., #38. and #39., #50., and #75.

When we re-treated patients with recurrences, they required shorter treatments than were necessary when they were initially seen. Some patients with Eczematoid Neurodermatitis and solar keratoses showed some thicker skin areas after the initial treatment but otherwise the skin was visually normal. We did not continue treatments in Topical Medications for Controlling Epidermal Symptoms such cases. However, their skin returned to normal within several months without any further treatment.

Compliance with the appropriate applications of the medications is an extremely important factor in treating the patients' skin symptoms. Skin requires at least seven to ten days to properly re-epithelialize damaged areas during the initial treatment attempts. Patients feel significantly better after two to three days of applications, but this is not a sufficient period of time in which the new skin can reach the necessary thickness over the previously damaged areas. However, the decrease in patients' discomfort commonly caused them to prematurely stop applications of the creams.

For that reason we treat patients with creams and lotions until repaired skin is evident. Then we treat them three to five days longer so that full thickness of the skin is achieved. At this point, treatment is stopped.

CONCLUSION

We researched the field of topical ancTinjectable medication currently available. We could not find any medication that resolves epidermal symptoms as quickly and effectively as ours. The epidermal symptoms in numerous diseases are the main problem for the patients because these symptoms adversely affect their ability to maintain a normal life and employment. We are sure that our medications will significantly improve the lives of numerous patients.

We used our creams and lotions on several patients with various etiologies of Topical Medications for Controlling Epidermal Symptoms disease, ranging from Eczema of various types and presentations to Solar Keratoses, Psoriasis including various parapsoriatic conditions, Rosacea, etc. The only basic criteria we used was that all patients presented with damaged integrity of the epidermis in the form of epidermal symptoms. These patients' before and after photos are presented in the pictorial part of the patent text. The patients displayed "cracked" epidermis, thin and transparent epidermis with microscopic damage to the continuity of the epidermis, or large areas of scaly presentation with erythematous presentation of the affected area. Patients presented with inflammation of the affected skin, which was either nonspecific or caused by specific bacterial, fungal or viral agents.

After initial application of the creams and, if necessary, lotions, patients with mild to moderate presentation had to apply the cream at least twice daily while patients with more pronounced expressions of their skin symptoms, such as those affected by Eczematoid Neurodermatitis and Psoriasis Vulgaris, were required to apply the medication three times daily. The patients pictorially presented in this patent with Psoriasis Vulgaris and Eczema also applied the lotion on the scalp in the evenings and mornings after showering. They had to apply our medications for one to two weeks. In most other patients the applications were discontinued after eight to ten days. Very occasionally, application was discontinued after two weeks or longer.

The young patient in the pictorial presentation in this paper showed several recurrences of symptoms. The third and fifth patients in the pictorial presentation exhibited recurrences of symptoms after two weeks, three months, and over two years, respectively, after the initial treatments. They were treated again and the epidermal Topical Medications for Controlling Epidermal Symptoms symptoms were resolved after eight to ten days. Thus, when symptoms recur, we established that a short application of four to ten days is sufficient.

Note: As we stated at the beginning of this paper, we do not claim that we have a definitive treatment for any skin condition. We are able to treat the epidermal symptoms of the patients' skins. It is our experience that the epidermal symptoms may recur. For permanent elimination of the epidermal symptoms only treatment of the underlying conditions will be successful.

Topical Medications for Controlling Epidermal Symptoms PREPARATION AND COMPOSITION OF THE CREAMS AND LOTIONS

Preparation of the active creams and lotions takes place in three steps:

1. Prepare the Base Creams and Lotions.

2. Add the prescription or OTC strength glucocorticoids. We used 0.25 grams of Triamcinolone Acetonide micronized glucocorticoid per 100 grams of Cream or Lotion for the prescription group of medications, 1.0 gram of Hydrocortisone Mic powder per 100 grams of Cream and Lotion for the OTC group.

3. Add powdered Salicylic Acid in an amount that corresponds to the severity of each patient's symptoms and the patient's observed response. Patients with less severe epidermal symptoms were treated with a lower concentration of Salicylic Acid (typically 3% to 5%). Patients with more severe symptoms were treated with higher concentrations of the Salicylic Acid (7% to 9%).

The base cream is composed as follows:

POLYSORBATE 80 LIQUID 2 GM

VANISHING CREAM 90.94 GM

ALOE VERA FREEZE DRIED 200:1 POWDER 0.24 GM

THYMOL CRYSTALS 0.02 GM

PRESERVED WATER (PARABEN) LIQUID 6.8GM

The base lotion is composed as follows:

POLYSORBATE 80 LIQUID 2 GM

ALOE VERA FREEZE DRIED 200:1 POWDER 0.24 GM Topical Medications for Controlling Epidermal Symptoms

PRESERVED WATER (PARABEN) LIQUID 47 GM

VANISHING CREAM 46.42 GM

THYMOL CRYSTAL CRYSTALS 0.02 GM

Both creams and lotions were mixed in a similar manner:

MIXING DIRECTIONS:

1. WEIGH AND ADD VANISHING CREAM TO EMP^*

2. WEIGH AND TRITURATE ALL POWDERS WITH POLYSORBATE 80 TO

SMOOTH PASTE IN GLASS MORTAR AND PESTLE

3. ADD STEP #2 TO STEP #1

4. ADD PRESERVED WATER TO STEP #1

5. EMP STEP #1 AT POWER 5 FOR 2 TO 5 MINUTES

6. DISPENSE IN APPROPRIATE SIZE EMP JARS UNLESS OTHERWISE

SPECIFIED

STORAGE: ROOM TEMPERATURE

* EMP= ELECTRONIC MORTAR AND PESTLE

At this point prescription or OTC strength glucocorticoids were added. They were emulsified for five to ten minutes in the Base Creams or Lotions to achieve the finest micelles possible.

Salicylic Acid was also emulsified for five to ten minutes. The amount of Salicylic Acid was determined based on the severity of the symptoms, age of the patient and, if the patient was previously treated with our creams or lotions, the clinical response to the treatment. Generally speaking, the more severe the symptoms, the higher the Topical Medications for Controlling Epidermal Symptoms concentration of Salicylic Acid used in the medication. However, we always started w a lower percentage of Salicylic Acid. Typically we started with 3% to 5%.

When a patient exhibited a slow response to the treatment, a high concentration of Salicylic Acid was used. After we changed our method of handling t patients enrolled in the trial, all patients responded adequately to the treatment. Sor patients resolved their symptoms in a week, while patients exhibiting more sevi symptoms resolved their symptoms after two weeks or more.

When a specific infection is diagnosed, appropriate antibiotic, anti-funj medication or anti viral compound may be added or patient may be treated separat from incorporating such agents in the creams and lotions.

Claims

What is Claimed:

1. A method and medications for treating epidermal skin symptoms and inflammatory reactions of the underlying dermis caused by of a variety of skin diseases from Eczema, Eczematoid Neurodermatitis, Psoriasis, Rosacea, and other diseases with similar symptoms using medications composed of Aloe Vera, commercially available vanishing cream, water and different concentrations of Salicylic Acid and certain Glucorticoids dispersed in the form of extremely small micelles.

2. A method and medications for treating epidermal skin symptoms and inflammatory reactions of Claim 1 comprising said medications in the form of semisolid aqueous creams composed of aloe Vera and commercially available vanishing cream having Pblysorbate 80 Liquid, Aloe Vera Freeze dried 200:1 powder, Preserved Water (Paraben) Liquid, EMP Jar, Red Device two UNITS per 100 grams cream and commercially available Vanishing Cream with active working medications and approximately 0-02 grams of Thymol crystals per 100 grams of cream for preservation under room temperature.

3. A method and medications for treating epidermal skin symptoms and inflammatory reactions of Claim 2 comprising finely emulsified Salicylic Acid in the form of micelles is added in concentrations from 3% to 10%, which is between the concentration required for desquamative effect for the. normal epidermis and the concentration that causes epidermal re-growth effects and in cases of less severe morphologic presentation of skin deseases, lower concei iaLiuus <_>.. oalicylic Acid, three to five percent, are used and in more severe cases, higher concentrations, five to ten percent, are used if the lower concentrations did not achieve resolution of the patients symptoms.

4. A method and medications for treating epidermal skin symptoms and inflammetory reactions of Claim 3, comprising finel emulsified glucocorticoid meditions in the form of micelles for treating the non-specifically inflamed and damaged

subeperdimis and alowing the subepidermis to accent re-growth of the surrounding epidermis to cover these desquamated areas.

5. A method and medications for treating epidermal skin symptoms and inflammetory reactions of Claim 4 with

glucocorticoid medications used in over-the-counter medications from the group including Hydrocortisone Mic Powder 99.34

emulsified in them and the patients were instructed to apply these creams three times daily.

6. A method and medications for treating epidermal skin symptoms and inflammatory reactions of Claim 5 when more severe presentations are encountered, from the group including some Parapsoriatic conditions including Rosacea, patients are

instructed to apply the cream with a prescripiton strength glucocorticoid medication from the group including Triamcinolone Acetonide micronized Powder emulsified in the cream three times daily in a very thin application and the treatment is monitored for a week to ten days and if cne results indicated the necessity of longer treatment, it is continued.

7. A method and medications for' treating epidermal skin

symptoms and inflammatory reactions of Claim 1 for treatment of scaly, presentation of hairy areas is in the form of aqueous lotions allowing patients to apply them easily over larger hairy areas and the lotions have the basic components, polysorbate

80 Liquid, commercially available Vanishing Cream, Aloe. Vera Freeze dried 200:1 powder, Preserved Water (Paraben) Liquid in a larger amount than was in the creams, Emp. Har, Red Device and Thymol crystals.

8. A method and medications for treating epidermal skin

symptoms and inflammatory reactions of Claim 7 wherein the first action of said lotions is to properly moisturize the affected skin, which is usually dry, scaly and hairy and a botanical component such as Aloe Vera, commercial vanishing cream using Poly sorbate 80 and Krisgel 100 are placed in EMP (electronic mortor pastle) resulting in extremely fine emulsified creams and thus proper skin moisturization and dispersion of the active substances in the creams affects the damaged skin.

9. A method and medications for treating epidermal skin

symptoms and inflammatory reactions of Claim 8 wherein the lotions contain finely emulsified Salicylic Acid in the form . of micelles, which were incorporated in concentrations in the range of 5% to 10%, which is between the concentration for desquamative effect for the normal epidermis and the concentration required for epiuc.ma-

effects and in cases of less severe morphologic presentation of skin diseases, lower concentrations of Salicylic Acid (five percent) are used in the more severe case, higher concentrations (seven to ten percent) are used if lower concentrations do not achieve resolution of the patient's problems.

10. A method and medications for treating epidermal skin symptoms and inflammatory reactions of Claim 9 with

glucocorticoid medication used in over-the-counter medications from the group of hydrocortisone Mic Powder 99.34 , or

gluco corticoid medication were emulsified in creams containing Salicylic Acid and the patients apply a very thin application in the evening and morning after showering.

11. A method and medications for treating epidermal skin symptoms and inflammatory reactions of Claim 9 wherein a more severe presentation of the >skin is encountered, from the group including severe Eczema, Eczematoid Neurodermatitis and some Parapsoriatic condiitons, the lotions under Claims 7, 8, and 9 with prescription strength glucocoticoid medication from the group of Triamcinolone Acetonide Micronized Powder or other containing Salicylic Acid and patients are instructed to apply it every evening and morning after showering and treatment is monitored for a week to ten days and if the results indicated necewssity for longer treatment, it was continued.

12. A method and medications for treating epidermal skin symptoms and inflammatory reactions of Claim 11 wherein the pharmacologic action of the aqueous locions is due to the

components incorporated as a group of active substances, each 'acting in its limited and specialized function in the aqueous lotions and the percentages of steroids in the lotions are identical to those in the creams but the Salicylic acid

percentages are usually higher in the lotions than they are in the creams because scaly areas are more resistant to the desquamative actions than non-hairy areas.

13. A method and medications for treating epidermal skin

symptoms and inflammatory reactions of the lotions for the pedeatric group of patients under Claims 7-11, start with 5% of the Salicylic Acid and could be higher and lotions for the adult group also may start at 5% and increase as necessary, typically to 7%, but may be up to 10%.

14. A method and medications for treating epidermal skin

symptoms and inflammatory reactions of medication wherein a patient has a bacterial, viral or fungal infection of the damaged skin area, appropriate medications for treating this complication may be added and the patient may also be treated separately from using the creams and lotions,

15. A method and medications for treating epidermal skin

symptoms and inflammatory reactions, when the original disease recurs with its epidermal or scaly symptoms, the patients are to be re-treated with the creams and lotions under Claim 1 , with treatment starting as soon as possible when initial signs of the epidermal damages appe r emu n a w_.ll shorten the duration of the necessary re-treatment .

16. A method and medications for treating epidermal skin symptoms and inflammatory reactions of debilitated patients, additional components, such as vitamins, may be added to the creams and lotions under claims 1-13.

17. A method and medications for treating epidermal skin symptoms and inflammatory reactions, patients with a good response to the creams and lotions use commercially available moisturizing creams after treatment as it will protect their skin from cracking and causing a sooner recurrence of their epidermal symptoms