At a glance
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A Phase 3 Clinical Trial to Confirm Efficacy and Evaluate Safety of Twice-daily Delgocitinib Cream 20 mg/g Compared With Cream Vehicle for a 16-week Treatment Period in Adult Subjects With Moderate to Severe Chronic Hand Eczema (DELTA 1)
In Brief
A Phase 3 clinical trial evaluating Delgocitinib cream and Cream vehicle for Chronic Hand Eczema. Completed, enrolled 487 participants across 54 sites in 6 countries.
Detailed Summary
This was a 16-week study in adult participants with chronic hand eczema (CHE). \> The participants visited the clinic regularly to have the study doctor assess their CHE and to answer questions about itch, pain, CHE symptoms, and quality of life. \> The purpose was to assess how delgocitinib cream works to treat CHE when compared to a placebo cream with no active substance.
Study Details
Timeline
Interventions
Cream for topical application
The cream vehicle is similar to the delgocitinib cream\> except that it does not contain any active ingredient.