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Phase III Trial of Topical Formulation of Sirolimus to Skin Lesions in Patients With Tuberous Sclerosis Complex (TSC)

NCT02635789 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2017-02-02

No results posted yet for this study

Summary

The purpose of this trial is to evaluate the efficacy and safety of NPC-12G gel (topical formulation of sirolimus) versus placebo gel to facial angiofibroma and other skin lesions in patients with tuberous sclerosis complex (TSC)

Conditions

  • Tuberous Sclerosis
  • Angiofibroma
  • Hypomelanotic Macule
  • Plaque

Interventions

DRUG

NPC-12G gel

NPC-12G gel is administered topically twice a day for 12 weeks

DRUG

Placebo gel

NPC-12G gel placebo is administered topically twice a day for 12 weeks

Sponsors & Collaborators

  • Nobelpharma

    lead INDUSTRY

Principal Investigators

  • Mari Wataya-Kaneda, MD, PhD · Department of Dermatology, Graduate School of Medicine, Osaka University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2016-10-31
Completion
2016-10-31

Countries

  • Japan

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02635789 on ClinicalTrials.gov