Delgocitinib Cream for Lichen Sclerosus

(DELTA CARE 1 Trial)

This trial tests a new cream, delgocitinib, to evaluate its effectiveness for individuals with mild to severe lichen sclerosus (LS), a skin condition often affecting the genital area and causing discomfort. The study consists of two parts: initially, it tests different doses on female participants to determine the optimal dose, then applies that dose to both men and women. Those with LS affecting the anogenital area, with symptoms ranging from mild to severe, might find this trial suitable. Participants will apply the cream twice daily and will be involved in the study for about a year. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Yes, you may need to stop certain medications before joining the trial. Specifically, you cannot use systemic immunosuppressive drugs, topical treatments on the anogenital area, or certain other medications within a specified time before starting the trial. Please discuss your current medications with the trial team to see if they are allowed.

Previous studies have shown that delgocitinib cream is safe. Research indicates that this cream is well-tolerated and does not significantly enter the bloodstream. For example, trials for chronic hand eczema demonstrated that delgocitinib was both safe and effective for adults. Its approval for treating moderate-to-severe chronic hand eczema suggests a good safety record. Overall, evidence suggests that delgocitinib cream is generally safe for use in humans.¹²³⁴⁵

Delgocitinib cream is unique because it targets Janus kinase (JAK) pathways, which play a crucial role in immune responses and inflammation, making it a promising option for treating lichen sclerosus. Unlike standard treatments like corticosteroids, which can have long-term side effects, delgocitinib offers a targeted approach that may reduce inflammation with potentially fewer side effects. Researchers are particularly excited about its potential to provide sustained relief with varying dosages, offering flexibility in treatment plans and improving quality of life for patients.

Research suggests that delgocitinib cream could help treat lichen sclerosus (LS), a long-lasting skin condition. Studies have found that delgocitinib blocks certain enzymes called Janus kinases (JAKs), which contribute to inflammation. In tests for similar skin issues like chronic hand eczema, delgocitinib cream proved effective and safe for patients. While specific results for LS are still being gathered, its success in treating other skin conditions suggests potential effectiveness for LS. Early reports also indicate it has few side effects. Participants in this trial will receive different dosages of delgocitinib cream or a cream vehicle to evaluate its effectiveness and safety for LS.¹²³⁴⁵