MedTrace Logo

Dose-Ranging Efficacy and Safety Study of Topical Rapamycin Cream for Facial Angiofibroma Associated With Tuberous Sclerosis Complex

NCT03826628 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2023-09-08

Study results available
· View outcomes & findings →

Summary

The study aims to compare the safety and efficacy of two different strengths of Rapamycin cream, topical and placebo over 26 weeks in the treatment of facial angiofibroma (FA) associated with Tuberous Sclerosis Complex (TSC).

Conditions

  • Facial Angiofibroma
  • Tuberous Sclerosis

Interventions

DRUG

rapamycin

Apply to the affected area once a day, approximately half an hour before retiring for bed in the evening, for 26 weeks

DRUG

placebo

Apply to the affected area once a day, approximately half an hour before retiring for bed in the evening, for 26 weeks

Sponsors & Collaborators

  • Dermatology Specialties Limited Partnership

    lead INDUSTRY

Principal Investigators

  • Ioana Stanescu · Dermatology Specialties Limited Partnership

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-28
Primary Completion
2022-09-01
Completion
2022-09-01
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Czechia
  • Hungary
  • New Zealand
  • Serbia
  • Slovakia
  • Spain
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs

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 NCT03826628 on ClinicalTrials.gov