Open Label Extension Study to Evaluate the Safety of SD-101 Cream in Subjects With Epidermolysis Bullosa
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label Extension, Multi-Center, Study to Evaluate the Safety of SD-101 Cream in Subjects With Epidermolysis Bullosa|
- Demonstrate the continued safety of SD-101 dermal cream (6%) [ Time Frame: up to 1080 days ] [ Designated as safety issue: Yes ]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: at week 2 and months 3, 6, 9, 12 ,15, 18, 21, 24, 27, 30, 33, and 36 ] [ Designated as safety issue: No ]Body coverage in blisters or lesions based on body surface area (BSA) measurements at baseline (end of study visit from Study SD-003), week 2, month 3, month 6, month 9, month 12, month 15, month 18, month 21, month 24, month 27, month 30, month 33 and month 36 using the Body Surface Area Index (BSAI).
|Study Start Date:||March 2014|
|Estimated Study Completion Date:||April 2017|
|Estimated Primary Completion Date:||April 2017 (Final data collection date for primary outcome measure)|
Experimental: SD-101 dermal cream (6%)
All subjects will apply SD-101 dermal cream topically, once a day to the entire body for a period of up to 1080 days.
Drug: SD-101 dermal cream (6%)
applied topically once a day to the entire body for 1080 days
Other Name: SD-101
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02090283
|United States, California|
|Stanford University School of Medicine|
|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|
|St. Louis, Missouri, United States, 63110|
|United States, New Jersey|
|Hackensack University Medical Center|
|Hackensack, New Jersey, United States, 07601|
|United States, North Carolina|
|University of North Carolina School of Medicine|
|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|