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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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12 December 2020 |
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Main ID: |
NCT02090283 |
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Date of registration:
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12/03/2014 |
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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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Open-Label Extension Study to Evaluate the Safety of SD-101 Cream in Participants With Epidermolysis Bullosa
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Scientific title:
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An Open Label Extension, Multi-Center, Study to Evaluate the Safety of SD-101 Cream in Subjects With Epidermolysis Bullosa |
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Date of first enrolment:
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March 26, 2014 |
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Target sample size:
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42 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02090283 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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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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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Amicus Therapeutics |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Informed consent form signed by the participant or participant's legal representative;
if the participant is under the age of 18 but capable of providing assent, signed
assent from the participant.
- Participant (or caretaker) must be willing to comply with all protocol requirements.
- Participant must have successfully completed the SD-003 study.
Exclusion Criteria:
- Participants who do not meet the inclusion criteria.
- Pregnancy or breastfeeding during the study. A urine pregnancy test will be performed
at the final visit for SD-003 for female participants of childbearing potential.
- Females of childbearing potential who are not abstinent and not practicing a medically
acceptable method of contraception.
Age minimum:
6 Months
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Epidermolysis Bullosa
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Intervention(s)
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Drug: SD-101 dermal cream (6%)
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Primary Outcome(s)
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Number Of Participants With Treatment-Emergent Adverse Events (TEAEs)
[Time Frame: From baseline to 30 days after last application of study drug (up to a maximum of 54 months)]
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Secondary Outcome(s)
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Change From Baseline In Body Surface Area Index (BSAI) Of Lesional Skin At Month 24
[Time Frame: Baseline, Month 24]
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Secondary ID(s)
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1R01FD005093-01
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SD-004
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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