JPRN-UMIN000036527CompletedPhase 2
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Efficacy and Safety of NPC-12G for Skin Lesions in Patients with Neurofibromatosis type 1 - NEDOC-2 Study
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Osaka University Hospital
- Enrollment
- 76
Study Overview
Brief Summary
0.2% NPC-12G, 0.4% NPC12-G and placebo were topically administered to the skin lesion of the patients with neurofibromatosis type 1 for 52 weeks. There were no statistical differences between the NPC12-G group and the placebo group regarding the efficacy evaluation. There were no serious side effects observed and there were no special concerns regarding the safety of 0.2% NPC-12G and 0.4% NPC12-G when topically administered to the skin lesion of the patients with neurofibromatosis type 1 for 52 weeks.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 3years-old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- Not provided
Exclusion Criteria
- •1) Patients who treated with mTOR inhibitors (sirolimus, everolimus or temsirolimus), within 12 months prior to enrollment. 2) Patients who treated with RAS-MAPK inhibitors (sorafenib, regorafenib or lenvatinib), within 12 months prior to enrollment. 3) Patients who have active infectious lesions. 4) Patients who have abnormal findings (pneumonic lesions) by chest X-ray inspection. 5) Patients with creatinine clearance less than 50ml/min. 6)Patients with uncontrolled dyslipidemia (serum triglyceride is 500mg / dL or more, or LDL cholesterol is 190mg / dL or more even treated) 7) Patients who have severe complications such as cardiac disease, liver disease, pulmonary disease, hematological disorder or malignant tumor . 8) Patients who have previously experienced alcoholic sensitivity or allergy to sirolimus. 9) Patients who are pregnant or lactating. 10) Patients who cannot agree to use effective contraceptive methods during the study period and until 8 weeks after treatment. 11) Patients who have entered another clinical trial within 6 months prior to enrollment.
Investigators
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