Daily Topical Rapamycin for Vitiligo
- Registration Number
- NCT05342519
- Lead Sponsor
- Medical University of South Carolina
- Brief Summary
In current Dermatology practice, options for vitiligo remain limited. The purpose of this study is to determine if once daily dosed topical rapamycin is effective for the treatment of patients with vitiligo. Participants will apply either 0.1% topical rapamycin or 0.001% topical rapamycin for six months to a lesion on one side of the body, and topical placebo to a corresponding lesion on the opposite side of the body. The study also aims to evaluate patient satisfaction and identify any adverse effects on these dosing regimens.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 20
- Patients 13 years of age and older
- Patients with nonsegmental vitiligo
- Patients with segmental or mucosal vitiligo
- Patients with contraindication to use of rapamycin
- Patients with history of transplant
- Patients with a history of natural immunodeficiency
- Patients with a history of artificially induced immunodeficiency
- Patients with a history of a serious or life-threatening infection
- Patients taking CYP3A4 inhibiting medications
- Patients taking strong CYP3A4 inducers
- Patients undergoing current treatment for vitiligo
- Women that are or may become pregnant
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo All patients will apply 2 FTU (0.5 cc) topical placebo cream daily for 6 months to the corresponding anatomic location on the opposite side of the body where the experimental drug is not being applied Topical rapamycin 0.001% Rapamycin Patients randomized to this arm of the study will apply 2 finger tip units (FTU) or 0.5 cc topical rapamycin 0.001% cream daily for 6 months Topical rapamycin 0.1% Rapamycin Patients randomized to this arm of the study will apply 2 FTU (0.5 cc) topical rapamycin 0.1% cream daily for 6 months
- Primary Outcome Measures
Name Time Method Number of lesions with no response 6 months Absence of change in appearance of targeted lesion. Vitiligo is a depigmenting disease and treatment responses are graded by percentage of repigmentation on a 5-point scale
Numbers of lesions with complete response 6 months Targeted lesion is no longer grossly visible.
Number of lesions with partial response 6 months There is change in the size of dyspigmentation as compared to its appearance and symptoms at the initial visit, but the lesion remains grossly visible. Vitiligo is a depigmenting disease and treatment responses are graded by percentage of repigmentation on a 5-point scale. Changes in the characteristics of the targeted lesions will be evaluated by a dermatologist and documented via photographs at follow-up visits at 2, 4, and 6-months, with the final outcome measured at the 6-month visit.
- Secondary Outcome Measures
Name Time Method Average score of Dermatology Quality of Life questionnaire (or Teenager Quality of Life Index) 6 months The Dermatology Life Quality Index (DLQI) is designed to measure the health-related quality of life of adult (or teenage) patients suffering from a skin disease. Both physical and psychological symptoms are ranked on a 4-point scale from "not at all" to "very much" to provide a cumulative patient score.
Trial Locations
- Locations (1)
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States