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

Trial ID or NCT#

NCT02014376

Status

recruiting iconRECRUITING

Purpose

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).

Official Title

A Phase 2b, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled Study of the Effectiveness and Safety of SD-101 Cream in Subjects With Epidermolysis Bullosa

Eligibility Criteria

Ages Eligible for Study: Older than 6 Months
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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.

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Contact

Emily Gorell
650-721-7166