Clinical trial NCT05342519: Daily Topical Rapamycin for Vitiligo
Official title: Daily Topical Rapamycin Therapy for the Treatment of Vitiligo
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Vitiligo
Keywords: Dermatology
Pediatrics
Rapamycin
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: American Skin Association
First posted: 2022-04-22
Enrollment: 20
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: During a clinical care visit, if a patient is eligible and agrees to participate, one lesion occupying less than 2% body surface area (BSA) will be identified for treatment with either 0.1% or 0.001% topical rapamycin cream to be applied daily for 6 months. Ten patients will be randomized to each treatment arm, however, if it is clear that one treatment arm is less effective, that treatment arm will be dropped, and study participants will be reallocated to the more effective treatment arm. A second, symmetric lesion about the same size and evolution time occupying less than 2% BSA will be identified for treatment with topical placebo cream to be applied daily for 6 months. The second lesion must be at the corresponding anatomic location on the other half of the body, i.e., if topical rapamycin is applied to the left arm, topical placebo will be applied to the right arm.
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Number of lesions with no response
timeFrame: 6 months
measure: Number of lesions with partial response
timeFrame: 6 months
measure: Numbers of lesions with complete response
timeFrame: 6 months
Secondary outcomes:
measure: Average score of Dermatology Quality of Life questionnaire (or Teenager Quality of Life Index)
timeFrame: 6 months
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Ahmad Aleisa, MD
role: PRINCIPAL_INVESTIGATOR
References: