An Open-Label Pilot Study to Evaluate the Effectiveness and Tolerability of a Topical Composition Therapy for the Treatment of Cutaneous Mastocytosis
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Cutaneous Mastocytoses
- Sponsor
- Joseph Butterfield
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Cutaneous Symptom Relief
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
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.
Investigators
Joseph Butterfield
Principal Investigator
Mayo Clinic
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Cutaneous Symptom Relief
Time Frame: 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
Time Frame: 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.