MedTrace Logo

Tuberous Sclerosis Complex: Facial Angiofibroma Skin Cream

NCT01853423 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2016-08-19

No results posted yet for this study

Summary

The objective of this study is to evaluate the safety and efficacy of a 0.1% formulation of rapamune cream in children with Tuberous Sclerosis Complex (TSC), ages 3 years and older, who have facial angiofibromas that would benefit from treatment.

Conditions

  • Facial Angiofibroma

Interventions

DRUG

Rapamune

Small amount of 0.1% rapamune ointment applied topically to affected facial areas twice daily for the first two weeks, then once daily.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • University of Tennessee

    collaborator OTHER

  • Le Bonheur Children's Hospital

    lead OTHER

Principal Investigators

  • James W Wheless, MD · LeBonheur Children's Hospital- Neuroscience Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2016-05-31
Completion
2016-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT01853423 on ClinicalTrials.gov