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Open Label Extension Study to Evaluate the Safety of SD-101 Cream in Subjects With Epidermolysis Bullosa

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Scioderm, Inc. Identifier:
First received: March 12, 2014
Last updated: October 31, 2016
Last verified: October 2016

The purpose of this study is to assess the continued safety of topical use of SD-101 cream (6%) in subjects with Epidermolysis Bullosa

"Funding-Source-FDA OOPD"

Condition Intervention
Epidermolysis Bullosa
Drug: SD-101 dermal cream (6%)

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Scioderm, Inc.:

Primary Outcome Measures:
  • Demonstrate the continued safety of SD-101 dermal cream (6%) [ Time Frame: up to 1080 days ]
    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%).

Secondary Outcome Measures:
  • 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 ]
    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).

Estimated Enrollment: 48
Study Start Date: March 2014
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed 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.


Ages Eligible for Study:   6 Months and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  Contacts and Locations
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Please refer to this study by its 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
Sponsors and Collaborators
Scioderm, Inc.
  More Information

Responsible Party: Scioderm, Inc. Identifier: NCT02090283     History of Changes
Other Study ID Numbers: SD-004
1R01FD005093-01 ( US NIH Grant/Contract Award Number )
Study First Received: March 12, 2014
Last Updated: October 31, 2016

Keywords provided by Scioderm, Inc.:
Epidermolysis Bullosa
Recessive Dystrophic
Junctional non-Herlitz

Additional relevant MeSH terms:
Epidermolysis Bullosa
Skin Abnormalities
Congenital Abnormalities
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases
Skin Diseases, Vesiculobullous processed this record on March 29, 2017