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Main
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Note: This record shows only 22 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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29 August 2016 |
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Main ID: |
NCT01853423 |
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Date of registration:
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12/04/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Tuberous Sclerosis Complex: Facial Angiofibroma Skin Cream
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Scientific title:
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Tuberous Sclerosis Complex: Facial Angiofibroma Skin Cream |
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Date of first enrolment:
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October 2013 |
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Target sample size:
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11 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01853423 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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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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James W Wheless, 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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LeBonheur Children's Hospital- Neuroscience Institute |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patient or his / her legally authorize representative (LAR) must sign and date the
approved informed consent prior to study participation or initiation of study
procedures. If appropriate, the patient will give written or verbal consent.
Surrogate consent will be obtained utilizing the "legally authorized representative
(LAR)". The LAR must be an adult who has exhibited special care and concern for the
subject, who is familiar with the subject's personal values, who is reasonably
available, and who is willing to serve. No person who is identified as a protective
order or other court order that directs that person to avoid contact with the subject
shall be eligible to serve as the subject's LAR. Identification of LAR should
normally be made using the following order of descending preference: Conservator,
guardian, attorney in fact, subject's spouse (unless legally separated), the
subject's adult child, the subject's parent, the subject's adult sibling, any other
adult relative of the subject, or other adult who is familiar with the patient's
personal values, who is reasonably available, and who is willing to serve.
1. Patient must have a diagnosis of Tuberous Sclerosis Complex.
2. Female or male patients over the age of 3 years.
3. Female subjects of child bearing potential must not be pregnant and must undergo
a pregnancy test, and must agree to use appropriate contraceptive methods
Exclusion Criteria:
- Patients will be excluded from entry into the study if any of the following are true:
1. Patient has a history of drug allergy to rapamune.
2. Patient is pregnant or lactating.
3. Subject is receiving therapy with Rapamycin.
4. Subject is receiving any form of immunosuppression or has previously experienced
immune dysfunction.
5. Subject is currently participating in or has participated within the Last 30
days in a clinical trial involving an investigative drug.
6. Subject has other dermatologic conditions that would preclude or prevent
adequate assessment of changes to their facial angiofibromas.
7. Subject has had laser surgery, cryotherapy, or other dermatologic treatment to
their facial angiofibromas within the previous 6 months.
Age minimum:
3 Years
Age maximum:
45 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Facial Angiofibroma
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Intervention(s)
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Drug: Rapamune
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Primary Outcome(s)
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Reduction of facial angiofibroma with use of rapamune facial skin cream
[Time Frame: 1 year]
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Secondary ID(s)
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UTHSC TSC01
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12-2008
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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