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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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16 December 2017 |
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Main ID: |
NCT03140449 |
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Date of registration:
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26/04/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Topical Rapamycin and Calcitriol for Angiofibroma of Tuberous Sclerosis
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Scientific title:
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Study of Combination Therapy With Topical Rapamycin and Calcitriol for Cutaneous Lesions of Tuberous Sclerosis: A Double-blind Randomized Controlled Trial |
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Date of first enrolment:
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September 5, 2013 |
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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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https://clinicaltrials.gov/show/NCT03140449 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
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Phase:
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Phase 3
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Contacts
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Name:
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YI-HUA LIAO, A.P. |
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Address:
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Telephone:
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Email:
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Affiliation:
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A.P. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Subjects must have been diagnosed or highly suspected as having TSC.
2. Subjects must be aged 7 to 70 years at Screening, and can be either sex.
3. Subjects must have symmetric facial angiofibromas.
Exclusion Criteria:
1. Pregnancy or with a plan to be pregnant.
2. Subjects who cannot comply the treatment protocol.
3. Subjects with kidney or liver/ biliary dysfunction.
4. Subjects with hypercalcaemia and patients known to suffer from abnormal calcium
metabolism.
5. Subjects on systemic treatment of calcium deficiency.
6. Subjects known to be hypersensitive to rapamycin or calcitriol.
Age minimum:
7 Years
Age maximum:
65 Years
Gender:
All
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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: Calcitriol
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Drug: Rapamycin-calcitriol combination
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Drug: Rapamycin
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Primary Outcome(s)
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facial angio?broma severity index (FASI)
[Time Frame: at week 12]
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Secondary ID(s)
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201306009MINB
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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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