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Topical Rapamycin Therapy to Alleviate Cutaneous Manifestations of Tuberous Sclerosis Complex and Neurofibromatosis 1


Phase 1
13 Years
N/A
Not Enrolling
Both
Tuberous Sclerosis, Neurofibromatoses, Angiofibroma, Neurofibroma

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Trial Information

Topical Rapamycin Therapy to Alleviate Cutaneous Manifestations of Tuberous Sclerosis Complex and Neurofibromatosis 1


Inclusion Criteria:



- Subject is willing and able to comply with all trial requirements

- Subject is male or female and over 13 years of age

- Subject has a diagnosis of either TSC or NF1 and has visible fibromatous lesions
(angiofibromas or neurofibromas)

- Female subjects of child-bearing potential must not be pregnant and must agree to use
appropriate contraceptive methods for the duration of the trial

Exclusion Criteria:

- Subject is currently receiving therapy with rapamycin or sirolimus

- 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
any clinical trial involving an investigational drug

- Subject has a known hypersensitivity to either the PVDF coating (Skincerity®) or
rapamycin

- Subject is a pregnant or nursing female

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:

Rapamycin level

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

Mary Kay Koenig, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The University of Texas Health Science Center, Houston

Authority:

United States: Institutional Review Board

Study ID:

HSC-MS-09-0259

NCT ID:

NCT01031901

Start Date:

December 2009

Completion Date:

June 2011

Related Keywords:

  • Tuberous Sclerosis
  • Neurofibromatoses
  • Angiofibroma
  • Neurofibroma
  • Tuberous Sclerosis
  • Neurofibromatoses
  • Angiofibroma
  • Neurofibroma
  • Sirolimus
  • Neurofibroma
  • Neurofibromatoses
  • Neurofibromatosis 1
  • Osteitis Fibrosa Cystica
  • Sclerosis
  • Tuberous Sclerosis
  • Angiofibroma

Name

Location

The University Of Texas Health Science CenterSan Antonio, Texas  78229