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Long-term Trial of Topical Sirolimus to Angiofibroma in Patient With Tuberous Sclerosis Complex

NCT02634931 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2019-02-20

No results posted yet for this study

Summary

The purpose of this trial is to evaluate the safety and efficacy of long-term treatment with NPC-12G gel (0.2% sirolimus gel) to angiofibroma and other skin lesions in patients with tuberous sclerosis complex in the open-label trial.

Conditions

  • Tuberous Sclerosis
  • Angiofibroma
  • Hypomelanotic Macule
  • Plaque

Interventions

DRUG

NPC-12G gel

NPC-12G gel is administered topically twice a day for 52 weeks or longer

Sponsors & Collaborators

  • Nobelpharma

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2018-10-31
Completion
2018-10-31

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 NCT02634931 on ClinicalTrials.gov