Overview

This trial is active, not recruiting.

Condition epidermolysis bullosa
Treatment sd-101 dermal cream (6%)
Sponsor Scioderm, Inc.
Start date March 2014
End date December 2018
Trial size 48 participants
Trial identifier NCT02090283, 1R01FD005093-01, SD-004

Summary

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"

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Primary purpose treatment
Masking no masking
Arm
(Experimental)
All subjects will apply SD-101 dermal cream topically, once a day to the entire body for the duration of the study.
sd-101 dermal cream (6%) SD-101
applied topically once a day to the entire body for the duration of the study.

Primary Outcomes

Measure
Demonstrate the continued safety of SD-101 dermal cream (6%)
time frame: Through study completion, which is anticipated to be approximately 5 years

Secondary Outcomes

Measure
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

Eligibility Criteria

All participants at least 6 months old.

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

Additional Information

Official title An Open Label Extension, Multi-Center, Study to Evaluate the Safety of SD-101 Cream in Subjects With Epidermolysis Bullosa
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2017.
Information provided to ClinicalTrials.gov by Scioderm, Inc..