TCP-25 Gel for Epidermolysis Bullosa

(STEP Trial)

This trial tests a new gel treatment called TCP-25 for individuals with specific types of the rare skin condition epidermolysis bullosa (EB), specifically DEB or JEB. The researchers aim to evaluate the gel's effectiveness and safety by comparing it to a placebo gel. This trial suits those diagnosed with DEB or JEB, confirmed by medical tests, who are not currently using certain antibiotics or steroids on the affected areas. Participants will receive the TCP-25 gel on some wounds, while others will receive the placebo to determine which works better. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

You may need to stop certain medications. If you're on systemic antibiotics or using topical antibiotics on the index wounds, you might need to stop. However, if you're on a stable dose of preventive antibiotics or using inhaled, eye, or nasal corticosteroids, you can continue those.

Research has shown that treatments like TCP-25 gel, such as Oleogel-S10, are safe for patients with epidermolysis bullosa (EB). In previous studies, Oleogel-S10 was well-tolerated, and most participants did not discontinue its use due to side effects. Although some unwanted effects occurred, they were uncommon.

Unlike other treatments for epidermolysis bullosa, which often involve symptom management with bandaging and wound care, TCP-25 gel offers a new approach by delivering a topical therapy directly to the affected areas. Researchers are excited about TCP-25 because it is designed to potentially accelerate healing and reduce blister formation, targeting the underlying causes rather than just alleviating symptoms. This gel-based delivery system may also provide a more convenient and less invasive option compared to other treatments that require more intensive care.

Research has shown that TCP-25 gel, which participants in this trial may receive, may help heal wounds in people with epidermolysis bullosa (EB). In one study, patients using TCP-25 gel saw their wound size shrink by an average of 76% after 29 days. The gel reduces inflammation and fights bacteria, potentially speeding up healing. Another study found a 78% reduction in wound size over a similar period. These results suggest that TCP-25 gel could effectively aid wound healing for people with EB.⁶⁷⁸⁹¹⁰