The Study Sponsor, Xinnate, is conducting a Phase 2 research study to determine if TCP-25, a topical anti-inflammatory and antibacterial gel, can effectively promote and maintain wound healing of DEB and JEB patient wounds, following repeat application and to evaluate the change from baseline in Patient Reported Outcomes.
Children above 4 years, teens and adults with DEB or JEB are eligible for participation. Patients are enrolled upon obtaining consent and meeting entry criteria. Participants must have at least one pair of matching wounds that are similar in size and location. The wounds in a pair will be randomized, such that one wound in the pair will receive TCP-25 and the other will receive a placebo. Subjects will be on-trial for approximately 3 months, with 6 bi-weekly visits to the clinical site.
During the study, the Investigator will complete physical exams, administer questionnaires, image and assess the study wounds, monitor your vitals and lab specimens as well as ask you how you are feeling. Additionally, they will monitor changes in your medications.
- Clinical diagnosis of the recessive or dominant form of dystrophic epidermolysis bullosa or junctional
- Age: 4 years or older at the time of consent
- At least two wounds that are similar in size and location
- Subjects, who are, in the opinion of the Investigator, 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
- Please visit ClinicalTrials.gov for exclusion criteria
This trial is not yet recruiting. Contacts and Locations will be posted once recruitment has begun.