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Topical Rapamycin to Erase Angiofibromas in TSC

NCT01526356 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 179

Last updated 2020-10-26

Study results available
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Summary

The study is a multi-center prospective, randomized, double-blind, placebo-controlled evaluation of the safety and efficacy of a topically applied formulation of rapamycin to cutaneous angiofibromas in subjects with Tuberous Sclerosis Complex (TSC). Subjects will apply either the topical vehicle containing rapamycin or the topical vehicle alone nightly to their angiofibromas for six months.

The primary goal of this study is to evaluate the efficacy of the topical medication for reduction of cutaneous angiofibromas in patients with TSC. The secondary goal of this study is to confirm the safety of the topical medication.

Conditions

  • Angiofibromas
  • Tuberous Sclerosis

Interventions

DRUG

Placebo

Study cream is applied nightly to the affected areas on the face.

DRUG

Rapamycin

Study cream is applied nightly to the affected areas on the face. Low Dose

DRUG

Rapamycin

Study cream is applied nightly to the affected areas on the face. High Dose

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Mary Kay Koenig, MD · The University of Texas Medical School at Houston

  • Hope Northrup, MD · The University of Texas Medical School at Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • United States
  • Australia

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 NCT01526356 on ClinicalTrials.gov