Study of Effectiveness and Safety of SD-101 in Participants With Epidermolysis Bullosa

• Status: Completed
• Trial end date: 2014-06-24
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to assess whether the topical use of SD-101 cream (3% or 6%) was effective in treating wounds in participants with Simplex, Recessive Dystrophic, or Junctional non-Herlitz Epidermolysis Bullosa (EB).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Scioderm, Inc.
• Collaborator: Amicus Therapeutics

Criteria

Inclusion Criteria:

• Informed Consent form signed by the participant or the participant's legal representative; if the participant is under the age of majority but capable of providing assent, signed assent from the participant.

• Participant (or caretaker) was willing to comply with all protocol requirements.

• Diagnosis of Simplex, Recessive Dystrophic, or Junctional non-Herlitz EB.

• Participants 6 months of age and older.

• Participants had 1 target wound within a prespecified size range at study entry.

• Target wound was at least 21 days or older.

Exclusion Criteria:

• Participants who did not meet all the entry criteria outlined in inclusion criteria.

• Selected target wound had clinical evidence of local infection.

• Use of any investigational drug within 30 days before enrollment.

• Use of immunotherapy or cytotoxic chemotherapy within 60 days before enrollment.

• Use of systemic or topical steroidal therapy within 30 days before enrollment (inhaled steroids and ophthalmic drops containing steroids were allowed).

• Use of systemic antibiotics within 7 days before enrollment.

• Current or former malignancy.

• Arterial or venous disorder resulting in ulcerated wounds.

• Diabetes mellitus.

• Pregnancy or breastfeeding during the study (a urine pregnancy test was performed at screening for female participants of childbearing potential).

• Females of childbearing potential who were not abstinent and not practicing a medically acceptable method of contraception.

• Known history of cardiac, hepatic, or renal disease.