Ph 3 Efficacy and Safety of B-VEC for the Treatment of DEB (NCT04491604) | Clinical Trial Compass
CompletedPhase 3
Ph 3 Efficacy and Safety of B-VEC for the Treatment of DEB
United States31 participantsStarted 2020-08-17
Plain-language summary
To determine whether administration of topical B-VEC improves wound healing as compared to placebo, and to evaluate durability, repeat dosing (Primary Endpoint) and further obtain safety and tolerability data.
Who can participate
Age range6 Months
SexALL
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Inclusion criteria
✓. The subject or legally appointed and authorized representative must have read, understood and signed an Institutional Review Board/Ethics Committee (IRB/EC) approved Informed Consent or Assent Form and must be able to and willing to follow study procedures and instructions.
✓. Age ≥ 6 months and older at the time of Informed Consent.
✓. Clinical diagnosis of the Dystrophic Epidermolysis Bullosa.
✓. Confirmation of DEB diagnosis (either DDEB or RDEB) by genetic testing including COL7A1.
✓. Two (2) cutaneous wounds meeting the following criteria:
✓. Location: similar in size, located in similar anatomical regions, and have similar appearance
✓. Appearance: clean with adequate granulation tissue, excellent vascularization, and do not appear infected.
✓. Subjects and caregivers who, in the opinion of the Investigator, are able to understand the study, co-operate with the study procedures and are willing to return to the clinic for all the required follow-up visits.
Exclusion criteria
✕. Medical instability limiting ability to travel to the Investigative Center.
✕. Diseases or conditions that could interfere with the assessment of safety and efficacy of the study treatment and compliance of the subject with study visits/procedures, as determined by the Investigator.
✕
What they're measuring
1
Primary Wound With Complete Wound Healing (100% Wound Closure) on Weeks 22 and 24 or Weeks 24 and 26