ESSENCE Study: Efficacy and Safety of SD-101 Cream in Participants With Epidermolysis Bullosa (NCT02384460) | Clinical Trial Compass
CompletedPhase 3
ESSENCE Study: Efficacy and Safety of SD-101 Cream in Participants With Epidermolysis Bullosa
United States169 participantsStarted 2015-03-11
Plain-language summary
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).
Who can participate
Age range1 Month
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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…
What they're measuring
1
Time To Complete Target Wound Closure Within 3 Months
Timeframe: From baseline to Month 3 visit
2
The Percentage Of Participants Experiencing Complete Closure Of Their Target Wound Within 3 Months