Topical Composition Therapy for the Treatment of Cutaneous Mastocytosis

NCT ID: NCT04846348

Last Updated: 2024-04-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-26
• Study Completion Date: 2021-09-10

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.

Conditions

Cutaneous Mastocytoses

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Topical preparation of sodium cromolyn 5%, diphenhydramine 1% and trolamine salicylate 10% in emollient cream base.

Intervention Type: COMBINATION_PRODUCT

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

Interventions

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

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

Skin Guard

Eligibility Criteria

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, isotretinoin
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Joseph Butterfield

OTHER

Sponsor Role: lead

Responsible Party

Joseph Butterfield

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Joseph Butterfield, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

20-011876

Identifier Type: -

Identifier Source: org_study_id