ESSENCE Study: Efficacy and Safety of SD-101 Cream in Participants With Epidermolysis Bullosa

Completed · Phase 3 · Has a placebo group

Conditions studied: Epidermolysis Bullosa

In brief

The aim was to assess the efficacy and safety of SD-101-6.0 cream versus Placebo (SD-101-0.0) cream in the treatment of skin lesions in participants with Epidermolysis Bullosa. Funding Source - United States Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD).

Key facts

Study ID

NCT02384460

Run by

Scioderm, Inc.

People needed

169

Starts

2015-03-11

Expected to finish

2017-07-05

Last updated by the study team

2020-04-09

Who can join

Age: 0 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Informed Consent form signed by the participant or participant's legal representative; if the participant was under the age of 18 but capable of providing assent, signed assent from the participant.
• Participant (or caretaker) must have been willing to comply with all protocol requirements.
• Diagnosis of Simplex, Recessive Dystrophic, or Junctional non-Herlitz EB.
• Participant must have had 1 target wound (size 10 to 50 cm\^2) at study entry.
• Participants 1 month and older.
• Target wound must have been present for at least 21 days.

You may not qualify if…

• Participants who did not meet the entry criteria outlined above.
• Selected target wound did not have clinical evidence of local infection.
• Use of any investigational drug within the 30 days before enrollment.
• Use of immunotherapy or cytotoxic chemotherapy within the 60 days before enrollment.
• Use of systemic or topical steroidal therapy within the 30 days before enrollment. (Inhaled steroids and ophthalmic drops containing steroids were allowed).
• Use of systemic antibiotics within the 7 days before enrollment.
• Current or former malignancy.
• Arterial or venous disorder resulting in ulcerated lesions.
• Pregnancy or breastfeeding during the study. (A urine pregnancy test was performed at screening and every 30 days until the final visit for female participants of childbearing potential).
• Females of childbearing potential who were not abstinent and not practicing a medically acceptable method of contraception.

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Redwood City, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Miami, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Columbia, Missouri, United States
• Study site — St Louis, Missouri, United States
• Study site — Lebanon, New Hampshire, United States
• Study site — Hackensack, New Jersey, United States
• Study site — East Setauket, New York, United States
• Study site — New York, New York, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Charleston, South Carolina, United States
• Study site — Austin, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Seattle, Washington, United States
• Study site — Kogarah, New South Wales, Australia
• Study site — Parkville, Victoria, Australia
• Study site — Parkville, Victoria, Australia
• Study site — Salzburg, Austria

Full record on ClinicalTrials.gov

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