Clinical Trials Logo

Clinical Trial 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).


Clinical Trial Description

Topical rapamycin has previously been used to treat FA associated with TSC, reducing erythema, papule size, while flattening lesions and improving skin texture. Topical rapamycin has been reported to be well tolerated. The efficacy and safety of a topical rapamycin cream at two strengths (0.5% and 1.0%) will be assessed during a 26 week double-blind treatment phase with assessments made at clinical visits at baseline, 2, 8, 14, 20 and 26 weeks, and at follow-up (4 weeks after the last dose of study drug). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03826628
Study type Interventional
Source Dermatology Specialties Limited Partnership
Contact
Status Completed
Phase Phase 2/Phase 3
Start date July 28, 2019
Completion date September 1, 2022

See also
  Status Clinical Trial Phase
Enrolling by invitation NCT06139172 - Promoting Prosocial Behavior in Syndromic Intellectual and Developmental Disabilities N/A
Recruiting NCT00001532 - Role of Genetic Factors in the Development of Lung Disease
Completed NCT00552955 - Effect of Fasting on the Size of Abdominal Lymphatic Tumors in Women
Recruiting NCT03422367 - JASPER Early Intervention for Tuberous Sclerosis N/A
Not yet recruiting NCT06081348 - Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders Phase 2
Unknown status NCT00490789 - Trial of Efficacy and Safety of Sirolimus in Tuberous Sclerosis and LAM Phase 2
Recruiting NCT04463316 - GROWing Up With Rare GENEtic Syndromes
Recruiting NCT06065852 - National Registry of Rare Kidney Diseases
Enrolling by invitation NCT03836300 - Parent and Infant Inter(X)Action Intervention (PIXI) N/A
Completed NCT02104011 - Treatment of Renal Angiomyolipomas in Tuberous Sclerosis by Beta-blockers Phase 2
Recruiting NCT02461459 - Autism Spectrum Disorder (ASD) and Intellectual Disability (ID) Determinants in Tuberous Sclerosis Complex (TSC)
Completed NCT01526356 - Topical Rapamycin to Erase Angiofibromas in TSC Phase 2
Withdrawn NCT03254680 - Turmeric as Treatment in Epilepsy N/A
Terminated NCT01092208 - Studies of Autistic Patients: Gene Networks and Clinical Subtypes
Active, not recruiting NCT01954693 - A Study of Everolimus in the Treatment of Neurocognitive Problems in Tuberous Sclerosis Phase 2
Completed NCT00989742 - Doxycycline In Lymphangioleiomyomatosis (LAM) Phase 4
Recruiting NCT05286632 - KidneYou - Innovative Digital Therapy N/A
Withdrawn NCT04344626 - Use of a Tonometer to Identify Epileptogenic Lesions During Pediatric Epilepsy Surgery N/A
Recruiting NCT05199402 - Clinical Trial Data Set Re-use With Statistical Methodologies Tailored for Clinical Trials in Rare Diseases
Recruiting NCT00001975 - Study of Skin Tumors in Tuberous Sclerosis