Study of Effectiveness and Safety of SD-101 in Participants With Epidermolysis Bullosa (NCT02014376) | Clinical Trial Compass
CompletedPhase 2
Study of Effectiveness and Safety of SD-101 in Participants With Epidermolysis Bullosa
United States48 participantsStarted 2014-01-06
Plain-language 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).
Who can participate
Age range6 Months
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 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…
What they're measuring
1
Participants With Documented Complete Closure Of The Target Wound Within 1 Month After Initiation Of Treatment