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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02090283
First Posted: March 18, 2014
Last Update Posted: April 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Scioderm, Inc.
  Purpose

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: None (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: 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%).


Secondary Outcome Measures:
  • 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).


Estimated Enrollment: 48
Study Start Date: March 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (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 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

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 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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 at 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
Information from the National Library of Medicine

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


Locations
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.
ClinicalTrials.gov Identifier: NCT02090283     History of Changes
Other Study ID Numbers: SD-004
1R01FD005093-01 ( U.S. FDA Grant/Contract )
First Submitted: March 12, 2014
First Posted: March 18, 2014
Last Update Posted: April 12, 2017
Last Verified: April 2017

Keywords provided by Scioderm, Inc.:
Epidermolysis Bullosa
Simplex
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