Clinical trial for development of topical rapamycin treatment for white macules due to tuberous sclerosis complex, vitiligo vulgaris, and other congenital diseases
Phase 2
Recruiting
- Conditions
- tuberous sclerosis complex, vitiligo vulgaris, white macules due to congenital diseases
- Registration Number
- JPRN-UMIN000006108
- Lead Sponsor
- Department of Dermatology Graduate School of Medicine, Osaka University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 21
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients with severe mental retardation who cannot carry out this treatment plan. 2) Patients who have allergy to macrolide antibiotics. 3) Patients who received oral administration of rapamycin or RAD001 within six months prior to the study entry. 4) Patients who received topical treatment of tacrolimus, vitamin D, or steroid within three months prior to the study entry. 5) Patients who received phototherapy or surgical therapy within six months prior to the study entry. 6) Patients during pregnancy or lactation 7) Patients who were judged unsuitable for this study by the investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in color and size of white macules at 4, 8, and 12 weeks
- Secondary Outcome Measures
Name Time Method Appearance of contact dermatitis Rapamycin levels in whole blood Numbers and shapes of melanocyte in specimens of skin tissue in the cases who agree with skin biopsy