Open Label Extension Study to Evaluate the Safety of SD-101 Cream in Subjects With Epidermolysis Bullosa
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|ClinicalTrials.gov Identifier: NCT02090283|
Recruitment Status : Terminated (The Sponsor voluntarily recalled SD-101 and terminated the study due to GMP deficiencies identified during an FDA inspection at the site of the manufacturer.)
First Posted : March 18, 2014
Last Update Posted : November 14, 2018
The purpose of this study is to assess the continued safety of topical use of SD-101 cream (6%) in subjects with Epidermolysis Bullosa
|Condition or disease||Intervention/treatment||Phase|
|Epidermolysis Bullosa||Drug: SD-101 dermal cream (6%)||Not Applicable|
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 trauma. 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 the duration of the study. 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 visit 2 through visit 14 (1080 days) to have BSA assessed. Body Surface Area will be assessed at all subsequent scheduled study center visits. Scheduled study center visits occur every 6 months after visit 14 (visits 16, 18, 20, etc.). After completion of visit 14, the next subject visit (visit 15) will be a phone call from the site to the patient. Telephone visits will occur every 6 months thereafter (visits 17,19, 21, etc.) and include assessment of adverse events and concomitant medications only. For female subjects of childbearing potential, a urine pregnancy test will be performed at visit 4 and every 6 months up to and including the final study visit.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Extension, Multi-Center, Study to Evaluate the Safety of SD-101 Cream in Subjects With Epidermolysis Bullosa|
|Actual Study Start Date :||March 26, 2014|
|Actual Primary Completion Date :||June 4, 2018|
|Actual Study Completion Date :||September 14, 2018|
Experimental: SD-101 dermal cream (6%)
All subjects will apply SD-101 dermal cream topically, once a day to the entire body for the duration of the study.
Drug: SD-101 dermal cream (6%)
applied topically once a day to the entire body for the duration of the study.
Other Name: SD-101
- Demonstrate the continued safety of SD-101 dermal cream (6%) [ Time Frame: Through study completion, which is anticipated to be approximately 5 years ]The primary objective is to demonstrate in subjects, with Simplex, Recessive Dystrophic, and Junctional non-Herlitz Epidermolysis Bullosa, the continued safety of SD-101 dermal cream (6%).
- Continue to assess the change in Body Surface Area (BSA) of blisters or lesions [ Time Frame: Through study completion, which is anticipated to be approximately 5 years ]Body coverage in blisters or lesions based on body surface area (BSA) measurements at baseline (end of study visit from Study SD-003), visit 2 through visit 14, and each subsequent scheduled study center visit using the Body Surface Area Index (BSAI).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02090283
|United States, California|
|Lucile Packard Children's Hopsital Dermatology Clinic|
|Palo Alto, California, United States, 94304|
|United States, Illinois|
|Ann & Robert H. Lurie Children's Hospital of Chicago|
|Chicago, Illinois, United States, 60611|
|United States, Missouri|
|Washington University School of Medicine-Dermatology|
|Saint Louis, Missouri, United States, 63110|
|United States, New Jersey|
|Hackensack University Medical Center|
|Hackensack, New Jersey, United States, 07601|
|United States, North Carolina|
|UNC Department of Dermatology|
|Chapel Hill, North Carolina, United States, 27516|
|United States, Texas|
|Texas Dermatology and Laser Specialists|
|San Antonio, Texas, United States, 78218|
|United States, Washington|
|Seattle Children's Hospital|
|Seattle, Washington, United States, 98105|
|Study Director:||Clinical Research||Amicus Therapeutics|