Clinical study of safety and efficacy of rapamycin topical medication for skin lesions due to tuberous sclerosis complex

Phase 2

Recruiting

• Conditions: Tuberous sclerosis complex

• Registration Number: JPRN-UMIN000015114
• Lead Sponsor: Department of Dermatology Graduate School of Medicine, Osaka University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-09-10
• Study Completion: 2015-12-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients who cannot carry out this treatment plan. 2) Patients who have a severe erosion or ulcer on the lesion. 3) Patients who have allergy to macrolide antibiotics. 4) Patients who received oral administration of rapamycin (sirolimus) , everolimus or temsirolimus within 12 months prior to the study entry. 5) Patients who received topical treatment of tacrolimus within three months prior to the study entry. 6) Patients who received laser or surgical therapy to the target lesion within six months prior to the study entry. 7) Patients who have complications such as severe heart disease, liver disease, lung disease, or blood disorders, and are considered unsuitable to participate in this study. 8) Patients with alcohol intolerance. 9) Patients who are pregnant or lactating. 10) Patients who cannot agree to use effective methods of contraception during this study. 11) Patients who were judged unsuitable for this study by the investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified