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Topical Sirolimus Ointment for Cutaneous Angiofibromas in Subjects With Tuberous Sclerosis Complex

NCT03363763 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-12-01

Study results available
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Summary

The objective of this study is to evaluate the safety and efficacy of sirolimus (0.2% and 0.4% formulations) and its vehicle when applied topically once daily for 12 weeks for the treatment of cutaneous angiofibromas in pediatric subjects with tuberous sclerosis complex (TSC).

Conditions

  • Angiofibroma of Face
  • Tuberous Sclerosis

Interventions

DRUG

Sirolimus 0.2%

Ointment for topical administration hs x 12 weeks

DRUG

Sirolimus 0.4%

Ointment for topical administration hs x 12 weeks

DRUG

Placebo ointment

Placebo ointment comparator for topical administration hs x 12 weeks

Sponsors & Collaborators

  • Aucta Pharmaceuticals, Inc

    lead INDUSTRY

Principal Investigators

  • Shoufeng Li, Ph.D · Aucta Pharmaceuticals, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-12
Primary Completion
2023-03-24
Completion
2023-03-24
FDA Drug
Yes

Countries

  • United States
  • China

Study Locations

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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 NCT03363763 on ClinicalTrials.gov