Topical Composition Therapy for the Treatment of Cutaneous Mastocytosis

Sponsor

Joseph Butterfield (Other)

Overall Status

Recruiting

CT.gov ID

NCT04846348

Collaborator

(none)

Enrollment

Location

Arm

17.2

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cutaneous Mastocytoses	Combination Product: Topical preparation of sodium cromolyn 5%, diphenhydramine 1% and trolamine salicylate 10% in emollient cream base.	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 26, 2021

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Skin Guard 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. 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 Other Names: Skin Guard

Arm

Intervention/Treatment

Experimental: Skin Guard

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.

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

Other Names:

Skin Guard

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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