Daily Topical Rapamycin for Vitiligo

• Status: Not yet recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of South Carolina
• Collaborator: American Skin Association
• Treatments: Sirolimus

Criteria

Inclusion Criteria:

• Patients 13 years of age and older

• Patients with nonsegmental vitiligo

Exclusion Criteria:

• 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