Trial record 12 of 37 for:    "epidermolysis bullosa simplex" OR "Epidermolysis Bullosa"

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:
Information provided by (Responsible Party):
Scioderm, Inc.
ClinicalTrials.gov Identifier:
NCT02090283
First received: March 12, 2014
Last updated: June 26, 2014
Last verified: June 2014
  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


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

Study Type: Interventional
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

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 450 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%).


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 and 15 ] [ 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, and month 15 using the Body Surface Area Index (BSAI).


Estimated Enrollment: 48
Study Start Date: March 2014
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (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 450 days.
Drug: SD-101 dermal cream (6%)
applied topically once a day to the entire body for 450 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 450 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 (at 14, 90, 180, 270, 360, 450 days respectively) to have BSA assessed. For female subjects of childbearing potential, a urine pregnancy test will be performed at visits 4, 6, and 7.

  Eligibility

Ages Eligible for Study:   6 Months and older
Genders Eligible for Study:   Both
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 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Scioderm, Inc.
ClinicalTrials.gov Identifier: NCT02090283     History of Changes
Other Study ID Numbers: SD-004
Study First Received: March 12, 2014
Last Updated: June 26, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 28, 2014