JPRN-UMIN000012420
Completed
Phase 1
Randomized, double-blind, placebo-controlled, clinical trial with OSD-001 for skin lesions due to tuberous sclerosis complex. - Clinical trial for development of OSD-001 for skin lesions due to tuberous sclerosis complex.
Department of Dermatology Graduate School of Medicine, Osaka University0 sites36 target enrollmentNovember 27, 2013
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Department of Dermatology Graduate School of Medicine, Osaka University
- Enrollment
- 36
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
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.
Outcomes
Primary Outcomes
Not specified
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