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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT01526356

NCT01526356
Completed Phase 2 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You must be willing and able to follow all the rules and requirements of the trial.
  • You have been diagnosed with Tuberous Sclerosis Complex (TSC) and have visible small skin growths on your face called facial angiofibromas (benign bumps typically found on the cheeks and nose).
  • If you are a woman who could become pregnant, you must not currently be pregnant and must agree to use a suitable form of birth control during the trial.

Who may not be able to join:

  • You are currently taking a medicine called Rapamycin (also known as sirolimus).
  • You are currently taking medication that suppresses your immune system, or you have had immune system problems in the past.
  • You are currently in another clinical trial using an experimental drug, or you were in one within the last 30 days.
  • You have a known allergy or sensitivity to Rapamycin or any of the ingredients in the treatment being tested.
  • You are pregnant or currently breastfeeding.
  • You have other skin conditions on your face that would make it difficult to properly assess any changes to your facial angiofibromas.
  • You have had laser surgery, freezing treatment (cryotherapy), or any other skin treatment on your facial angiofibromas within the last 6 months.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 2
Sponsor
The University of Texas Health Science Center, Houston
Registry
clinicaltrials_gov
Start date
1 May 2012
Est. completion
1 August 2014

Where this trial is recruiting

🇦🇺 Australia 🇺🇸 United States

1 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Change From Baseline in the Facial Angiofibroma Grading Scale (AGS) Score

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov