Tuberous sclerosis complex
Conditions
Interventions
0.05% Sirolimus gel(adult)
0.1% Sirolimus gel(adult)
0.2% Sirolimus gel(adult)
0.05% Sirolimus gel(children)
0.1% Sirolimus gel(children)
0.2% Sirolimus gel(children)
Sponsors
Department of Dermatology Graduate School of Medicine, Osaka University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients diagnosed as tuberous sclerosis complex based on the clinical diagnostic criteria in guideline of Japanese Dermatological Association. 2) Patients who have three or more isolated lesions of facial angiofibroma. 3) Patients to whom laser therapy or surgical therapy is not applicabie or patients who do not want to receive surgical treatments.
Exclusion criteria
Exclusion criteria: 1) Patients who cannot carry out this treatment plan or follow-up assessment. 2) Patients who have serious skin lesions such as erosions or ulcers. 3) Patients who have allergy to macrolide antibiotics. 4) Patients who received sirolimus, everolimus or temsirolimus administration within twelve months prior to the study entry. 5) Patients who received topical treatment of tacrolimus, vitamin D or steroid within three months prior to the study entry. 6) Patients who received laser therapy or surgical therapy within six months prior to the study entry. 7) Patients during pregnancy or lactation. 8) Patients who were judged unsuitable for this clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in color and size of skin lesions at 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Global improvement rating Patients satisfaction | — |
Countries
Japan
Contacts
Public ContactMari Wataya-Kaneda
Graduate School of Medicine, Osaka University Department of Dermatology
Outcome results
None listed