Daily Topical Rapamycin for Vitiligo

Medical University of South Carolina (MUSC)

Status and phase: Active, not recruiting; Phase 2

Conditions: Vitiligo

Treatments: Drug: Rapamycin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05342519

115924

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 3 patient groups, including a placebo group

Topical rapamycin 0.001%

Experimental group

Description:

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

Treatment:

Drug: Rapamycin

Drug: Rapamycin

Topical rapamycin 0.1%

Active Comparator group

Description:

Patients randomized to this arm of the study will apply 2 FTU (0.5 cc) topical rapamycin 0.1% cream daily for 6 months

Treatment:

Drug: Rapamycin

Drug: Rapamycin

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo