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NPC-12G gel for facial angiofibroma in TSC
NCT02635789Phase 3
Key facts
- Status
- Completed
- Start
- Dec 2015
- Primary completion
- Oct 2016
- Countries
- 1
- Sponsor
- Nobelpharma Co., Ltd.
- Modality
- Small Molecules
- Drugs
- sirolimus
- Conditions
- tuberous sclerosis complex (TSC)
01
Overview
Phase 3, randomised, double-blind trial in tuberous sclerosis complex (TSC) comparing NPC-12G gel with Placebo gel (2 arms). Primary endpoint: Improvements in angiofibroma at 12 weeks. Started Dec 2015; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
NPC-12G gel
0.2% Sirolimus gel applied twice daily
Placebo gel
Placebo gel applied twice daily
03
Who it enrols
Patients 3 years or older with definite Tuberous Sclerosis Complex and at least 3 facial angiofibromas (>= 2mm with redness). Excludes patients with recent mTOR inhibitor use (12 months), topical tacrolimus (3 months), or laser/surgery (6 months).
04
Endpoints
Primary
Improvements in angiofibroma
Secondary
Improvements in angiofibroma
Improvements in redness of angiofibroma
Improvements in hypomelanotic macule and plaque of upper neck
The rate of patients who are evaluated as 'improvement' or more
Change in total score from baseline for DLQI and CDLQI
Adverse events
Sirolimus blood concentration
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