When compared to a vehicle control cream, researchers said delgocitinib cream proved more efficacious.
When compared to a vehicle control cream, delgocitinib cream improved itch, pain, and other symptoms of chronic hand eczema.
In a recent study,1 researchers sought to determine the safety and efficacy of the cream in patients with mild to severe disease states, citing a lack of specifically-approved drugs and therapies for the condition. Additionally, they aimed to establish a dose-response relationship between the drug and the condition.
The phase 2b trial, which was 5-arm, double-blind, randomized, parallel-group, and vehicle-controlled, spanned multiple centers and was dose-ranging in nature. Researchers also sought a secondary endpoint of improvement to participants’ health-related quality of life.
258 patients with chronic, mild to severe atopic dermatitis impacting their hands were eligible for participation in the trial. All prospective participants partook in a less than or equal to 4-week screening period before being assigned to treatment.
Using a 1:1:1:1:1 ration, researchers assigned participants to 1 of several treatment groups, including:
From the end of the screening period (baseline) through 16 weeks, all participants were instructed to apply their assigned treatment at a twice-daily rate.
During the last week of the screening period and throughout the entire duration of the treatment portion of the study, researchers conducted qualitative patient interviewsin accordance with the Hand Eczema Symptom Diary (HESD) on a daily basis. Each week, all participants were required to complete the patient interview a minimum of 4 times in order for researchers to establish a weekly symptom average. Interviews assessed patients for symptoms (burning sensation, itch, pain) and signs (bleeding, cracking, dryness, flaking, oozing/weeping, redness, swelling, thickening) on an 11-point numeric rating scale.
By the conclusion of the study, HESD itch scores had changed more significantly from baseline in participants being treated with delgocitinib than the vehicle cream, apart from for the 3 mg/g group. 40% of participants in the 1 mg/g group experienced a greater than or equal to 4 weekly average reduction in itch score. This benchmark was reached by 30.8% of those in the 3 mg/g group, 54.8% in the 8 mg/g group, 48.4% in the 20 mg/g group, and 17.9% in the vehicle control group.
At week 16, HESD pain scores were also more significant among all of the delgocitinib treatment groups than among the control cream group. Furthermore, with respect to burning sensations, participants in the 1, 8, and 20 mg/g delgocitinib groups experienced significant reductions from baseline.
Potential study limitations included the use of the HESD tool, which is new tool developed in managing chronic hand eczema. Researchers also cited a lack of diversity among participants and recommended further qualification research related to meaningful clinical change and the numeric rating scale.
“In this study, delgocitinib cream reduced itch and pain, as well as other signs and symptoms of CHE [chronic hand eczema] as recorded by patients using the HESD, further supporting the potential of delgocitinib cream as an effective topical treatment for patients with CHE,” study authors wrote.