Topical Composition Therapy for the Treatment of Cutaneous Mastocytosis

Study Overview
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Brief Summary
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The purpose of this study is to determine the effectiveness and tolerability of a novel topical preparation for the treatment of cutaneous lesions of mastocytosis.

Official Title
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An Open-Label Pilot Study to Evaluate the Effectiveness and Tolerability of a Topical Composition Therapy for the Treatment of Cutaneous Mastocytosis

Conditions
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Cutaneous Mastocytoses

Intervention / Treatment
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* Combination Product: Topical preparation of sodium cromolyn 5%, diphenhydramine 1% and trolamine salicylate 10% in emollient cream base.


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Biopsy proven cutaneous mastocytosis with or without evidence of systemic disease Male and female patients 18 to 80 years of age No UVB treatment of the skin for 6 months prior to study entry No use of topical or systemic corticosteroids for 1 month prior to study entry Good general health as confirmed by medical history Female patients of child-bearing potential with negative urine pregnancy test who agree to use effective methods of birth control or remain abstinent during treatment. Participants must use birth control for the entire study and for at least 1 week after the last application of the study formulation. Acceptable methods of birth control include ongoing hormonal contraception methods, (such as birth control pills, patches, injections, vaginal ring, or implants), barrier methods (such as a condom (for men) or diaphragm used with a spermicide), intrauterine devices, tubal ligation, or abstinence. Patients who are willing and capable of cooperating to the extent and degree required by the protocol; and Patients who read and sign an approved informed consent for this study Exclusion criteria Vulnerable study population Exposure to ultraviolet B (UVB) radiation to any region of the skin surface for 6 months Regular use of skin lightening agents within 1 month of study entry, including Topical corticosteroids Topical bleaching products Topical retinoids Use of systemic preparations within 1 month of study entry, including: Systemic corticosteroids Systemic cyclosporine, interferon Systemic acitretin, etretinate, isoretinoin Systemic methotrexate, Systemic photoallergic, phototoxic and/or photosensitizing drugs UV light therapy and sunbathing Inability to communicate or cooperate with the Principal Investigator and/or Investigators due to language problems, poor mental development or impaired cerebral function Pregnant or nursing women Women planning a pregnancy within the study period

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Skin Guard<br>Skin cream combination of ingredients includes 2 agents which target mast cell mediators and one agent which globally reduces mast cell degranulation combined in an emollient cream base: Vanicream: Over the counter emollient cream Diphenhydramine Antihistamine Trolamine salicylate Prostaglandin inhibitor, antiinflammatory Cromolyn Sodium Mast cell degranulation inhibitor | Combination Product: Topical preparation of sodium cromolyn 5%, diphenhydramine 1% and trolamine salicylate 10% in emollient cream base.<br>* Combination of ingredients includes 2 agents which target mast cell mediators and one agent which globally reduces mast cell degranulation combined in an emollient cream base (Vanicream).components: Vanicream: Over the counter emollient cream Diphenhydramine Antihistamine Trolamine salicylate Prostaglandin inhibitor, antiinflammatory Cromolyn Sodium Mast cell degranulation inhibitor<br>* Other names: Skin Guard;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cutaneous symptom relief | Number of participants who achieve complete resolution or near-complete clearing of cutaneous symptoms of treated, involved skin | 4 weeks | 
| SkinDex-16 Quality of Life | Change in Skindex-16 score. Skindex-16 is a validated measurement of the effects of skin diseases on patients' quality of life | Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks |