TerminatedPhase 2

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

Stopped: The Sponsor voluntarily recalled SD-101 and terminated the study due to GMP deficiencies identified during an FDA inspection at the site of the manufacturer.

United States42 participantsStarted 2014-03-26

Plain-language summary

The purpose of this study was to assess the continued safety of topical use of SD-101 cream (6%) in participants with Epidermolysis Bullosa (EB). Funding Source: FDA Office of Orphan Products Development

Who can participate

Age range6 Months

SexALL

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Inclusion Criteria: * Informed consent form signed by the participant or participant's legal representative; if the participant is under the age of 18 but capable of providing assent, signed assent from the participant. * Participant (or caretaker) must be willing to comply with all protocol requirements. * Participant must have successfully completed the SD-003 study. Exclusion Criteria: * Participants 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 participants of childbearing potential. * Females of childbearing potential who are not abstinent and not practicing a medically acceptable method of contraception.

What they're measuring

Number Of Participants With Treatment-Emergent Adverse Events (TEAEs)

Timeframe: From baseline to 30 days after last application of study drug (up to a maximum of 54 months)

Trial details

NCT IDNCT02090283

SponsorScioderm, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-09-14

Results submitted2019-09-10

View on ClinicalTrials.gov More Epidermolysis Bullosa trials