Topical Composition Therapy for the Treatment of Cutaneous Mastocytosis

Phase 2

Terminated

• Conditions: Cutaneous Mastocytoses
• Interventions: Combination Product: Topical preparation of sodium cromolyn 5%, diphenhydramine 1% and trolamine salicylate 10% in emollient cream base.

• Registration Number: NCT04846348
• Lead Sponsor: Joseph Butterfield

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-12
• Study First Submitted QC: 2021-04-12
• Study First Posted: 2021-04-15
• Study Start: 2021-07-26
• Primary Completion: 2021-09-10
• Study Completion: 2021-09-10
• Status Verified: 2024-03
• Results First Submitted: 2024-03-30
• Results First Submitted QC: 2024-03-30
• Last Update Submitted: 2024-03-30
• Results First Posted: 2024-04-25
• Last Update Posted: 2024-04-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Skin Guard	Topical preparation of sodium cromolyn 5%, diphenhydramine 1% and trolamine salicylate 10% in emollient cream base.	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

Primary Outcome Measures

Name	Time	Method
Cutaneous Symptom Relief	2 weeks	Number of participants who achieve complete resolution or near-complete clearing of cutaneous symptoms of treated, involved skin
SkinDex-16 Quality of Life Questionnaire	2 weeks	This validated questionnaire is a 16-item, participant-reported survey used to assess quality of life impacts due to the participant's skin condition. Scores range from 0 to 6, where 0 is never bothered by the skin condition and 6 is always bothered by the skin condition. Results are summed to produce an overall score, ranging from 0 to 96, where lower scores indicated a higher level of quality of life.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States