Open Label Extension Study to Evaluate the Safety of SD-101 Cream in Subjects With Epidermolysis Bullosa
This trial is active, not recruiting.
|Treatment||sd-101 dermal cream (6%)|
|Start date||March 2014|
|End date||September 2017|
|Trial size||48 participants|
|Trial identifier||NCT02090283, 1R01FD005093-01, SD-004|
The purpose of this study is to assess the continued safety of topical use of SD-101 cream (6%) in subjects with Epidermolysis Bullosa
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Palo Alto, CA||Stanford University School of Medicine||no longer recruiting|
|Chicago, IL||Ann & Robert H. Lurie Children's Hospital of Chicago||no longer recruiting|
|St. Louis, MO||Washington University School of Medicine||no longer recruiting|
|Hackensack, NJ||Hackensack University Medical Center||no longer recruiting|
|Chapel Hill, NC||University of North Carolina School of Medicine||no longer recruiting|
|San Antonio, TX||Texas Dermatology and Laser Specialists||no longer recruiting|
|Seattle, WA||Seattle Children's Hospital||no longer recruiting|
|Endpoint classification||safety study|
|Intervention model||single group assignment|
All subjects will apply SD-101 dermal cream topically, once a day to the entire body for a period of up to 1080 days.
Demonstrate the continued safety of SD-101 dermal cream (6%)
time frame: up to 1080 days
Continue to assess the change in Body Surface Area (BSA) of blisters or lesions
time frame: at week 2 and months 3, 6, 9, 12 ,15, 18, 21, 24, 27, 30, 33, and 36
Male or female participants at least 6 months old.
- Informed consent form signed by the subject or subject's legal representative; if the subject is under the age of 18 but capable of providing assent, signed assent from the subject.
- Subject (or caretaker) must be willing to comply with all protocol requirements.
- Subject must have successfully completed the SD-003 study.
- Subjects who do not meet the inclusion criteria.
- Pregnancy or breastfeeding during the study. (A urine pregnancy test will be performed the the final visit for SD-003 for female subjects of childbearing potential)
- Females of childbearing potential who are not abstinent and not practicing a medically acceptable method of contraception
|Official title||An Open Label Extension, Multi-Center, Study to Evaluate the Safety of SD-101 Cream in Subjects With Epidermolysis Bullosa|
|Description||Epidermolysis Bullosa (EB) is a rare group of inherited disorders that manifest as blistering or erosion of the skin and in some cases, the epithelial lining of other organs, in response to little or no apparent trama. There is a lack of effective agents for skin disorders involving blistering and lesion formation. Current approved therapies are minimally effective and have safety issues. Scioderm has developed SD-101 Dermal Cream (6%) for treatment of EB. This is an open label extension study to assess the continued safety of topically applied SD-101 Dermal Cream (6%) in subjects with Simplex, Recessive Dystrophic, and Junctional non-Herlitz Epidermolysis Bullosa. SD-101 Dermal Cream (6%) will be applied topically, once a day to the entire body for a period of 1080 days. Subjects who successfully complete the entire SD-003 study will have the option to roll over into the SD-004 study. The baseline visit 1 will occur at the final visit date for SD-003. The Body Surface Area (BSA) coverage of blisters and lesions assessment made at the final SD-003 study visit will be used as the baseline information at visit 1 for the SD-004 study. The subject will return to the study site for visits 2, 3, 4, 5, 6, and 7, 8, 9, 10, 11, 12, 13, and 14 (at 14, 90, 180, 270, 360, 450, 630, 720, 810, 900, 990, and 1080 days respectively) to have BSA assessed. For female subjects of childbearing potential, a urine pregnancy test will be performed at visits 4, 6, 8, 10, 12 and 14.|
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