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Phase II Study of Topical Rapamycin to Erase Angiofibromas in TSC-Multicenter Evaluation of a Novel Therapy


Phase 2
N/A
N/A
Open (Enrolling)
Both
Angiofibromas, Tuberous Sclerosis

Thank you

Trial Information

Phase II Study of Topical Rapamycin to Erase Angiofibromas in TSC-Multicenter Evaluation of a Novel Therapy


Inclusion Criteria:



- Subjects must be willing and able to comply with all trial requirements.

- Subject has a diagnosis of TSC and has visible facial angiofibromas.

- Female subjects of child bearing potential must not be pregnant and must agree to use
appropriate contraceptive methods .

Exclusion Criteria:

- Subject is currently receiving therapy with Rapamycin.

- Subject is receiving any form of immunosuppression or has previously experienced
immune dysfunction.

- Subject is currently participating in or has participated within the last 30 days in
a clinical trial involving an investigational drug.

- Subject has a known hypersensitivity to either the vehicle or Rapamycin.

- Subject is a pregnant or nursing female.

- Subject has other dermatologic conditions that would preclude or prevent adequate
assessment of changes to their facial angiofibromas.

- Subject has had laser surgery, cryotherapy, or other dermatologic treatment to their
facial angiofibromas within the previous 6 months.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Reduction in lesion size and appearance

Outcome Description:

Photographic, visual, and measurable reduction in the size and severity of the lesions.

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Mary Kay Koenig, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The University of Texas Medical School at Houston

Authority:

United States: Federal Government

Study ID:

HSC-MS-11-0501

NCT ID:

NCT01526356

Start Date:

May 2012

Completion Date:

August 2013

Related Keywords:

  • Angiofibromas
  • Tuberous Sclerosis
  • Angiofibroma
  • Tuberous Sclerosis
  • Rapamycin
  • Sirolimus
  • mTOR
  • Sclerosis
  • Tuberous Sclerosis
  • Angiofibroma

Name

Location
Cincinnati Children's Hospital Medical Center Cincinnati, Ohio  45229-3039
University of Alabama at Birmingham Birmingham, Alabama  35294-3300
The University Of Texas Medical School At Houston Houston, Texas  77030
Jack & Julia Center for TSC at Oakland Children's Hospital & Research Center Oakland, California  94609
Herscot Center for Adults and Children with TSC Massachusetts General Hospital Boston, Massachusetts  02114
Clinic Without Walls Saint Paul, Minnesota  55102-2697
Texas Scottish Rite Hospital Dallas, Texas  75219