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Terminated Phase 2 Interventional Results available

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

ClinicalTrials.gov ID: NCT03363763

Public ClinicalTrials.gov record NCT03363763. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 1:48 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Phase 2 Multi Center Prospective Rand. Double Blind Placebo Cont. Parallel Design Study to Evaluate Safety & Efficacy of Topical Sirolimus for Cutaneous Angiofibromas in Subjects W/ Tuberous Sclerosis Complex Followed by Opt. Open Label

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT03363763
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 2
Lead sponsor
Aucta Pharmaceuticals, Inc
Industry
Enrollment
24 participants

Conditions and interventions

Eligibility (public fields only)

Age range
2 Years to 21 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 12, 2017 (Actual)
Primary completion
Mar 24, 2023 (Actual)
Completion
Mar 24, 2023 (Actual)
Last update posted
Dec 1, 2025

2017 – 2023

United States locations

U.S. sites
7
U.S. states
7
U.S. cities
7
Facility City State ZIP Site status
Translational Genomics Research Phoenix Arizona 85004 —
Children's Hospital of Los Angeles, Division of Neurology Los Angeles California 90027 —
Children's Clinical Research Organization, Children's Hospital Colorado Aurora Colorado 80045 —
Children's Healthcare of Atlanta Atlanta Georgia 30329 —
Boston Children's Hospital Boston Massachusetts 02115 —
Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104 —
LeBonheur Children's Hospital Memphis Tennessee 38103 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03363763, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 1, 2025 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03363763 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →