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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01031901 |
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Date of registration:
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10/12/2009 |
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Primary sponsor: |
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Public title:
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Topical Rapamycin Therapy to Alleviate Cutaneous Manifestations of Tuberous Sclerosis Complex (TSC) and Neurofibromatosis I (NF1)
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Scientific title:
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Topical Rapamycin Therapy to Alleviate Cutaneous Manifestations of Tuberous Sclerosis Complex and Neurofibromatosis 1 |
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Date of first enrolment:
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December 2009 |
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Target sample size:
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52 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01031901 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Hope Northrup, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The University of Texas Health Science Center, Houston |
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Name:
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Mary Kay Koenig, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The University of Texas Health Science Center, Houston |
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Key inclusion & exclusion criteria
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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
Age minimum:
13 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Angiofibroma
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Neurofibroma
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Neurofibromatoses
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Tuberous Sclerosis
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Intervention(s)
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Drug: Skincerity
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Drug: Skincerity plus sirolimus/rapamycin
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Drug: Skinercity plus sirolimus/rapamycin
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Primary Outcome(s)
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Complete blood count
[Time Frame: 6 months]
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Dermatologic sensitivity at site of application (pain, erythema, edema, pruritis)
[Time Frame: 6 months]
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Rapamycin level
[Time Frame: 6 months]
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Total cholesterol
[Time Frame: 6 months]
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Secondary Outcome(s)
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Reduction in lesion size and appearance
[Time Frame: 6 months]
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Secondary ID(s)
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HSC-MS-09-0259
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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