DELTA FORCE
Research type
Research Study
Full title
A 24 week, randomised, assessor blinded, active-controlled, parallel group, phase 3, 2 arm trial to compare the efficacy and safety of delgocitinib cream 20 mg/g twice-daily with alitretinoin capsules once-daily in adult participants with severe chronic hand eczema
IRAS ID
1004431
Contact name
Elin Hoffmann
Contact email
Sponsor organisation
LEO Pharma A/S
Eudract number
2021-003543-16
ISRCTN Number
ISRCTN44123892
Research summary
Chronic hand eczema (CHE) is a serious inflammatory skin disorder located anywhere on the hands or wrists. It is characterised by erythema (rash), hyperkeratosis (thickening of the outer layer of skin) and oedema (swelling). CHE is generally difficult to treat and presents with periods of flares and remissions. As the currently available treatment options either lack documented treatment effect or are limited by restrictions of long-term use due to safety concerns, there is a high unmet medical need for new topical treatments of moderate to severe CHE, especially for long-term use. New and better treatments would potentially improve the everyday lives of patients with moderate to severe CHE.
This study will compare the effectiveness, safety and affect on general health status and quality of life of delgocitinib cream and alitretinoin capsules for treating patients with CHE. Delgocitinib, an experimental medication, is a pan JAK inhibitor (blocks specific processes, such as immune pathways, in the body’s response to conditions like hand eczema). Alitretinoin is the only approved product specifically indicated for treatment of CHE, but it is only indicated for severe CHE and only approved in a few countries worldwide.
This study is randomised, which means that which of these two medications participants will receive is chosen at random. A computer will randomly select participants treatment. Participants will have a 50% chance of receiving any one of these medications. Participants assigned to receive delgocitinib will apply delgocitinib cream to the skin twice a day for 16 weeks Participants assigned to receive Alitretinoin will take Alitretinoin by mouth once a day for 12 weeks. All participants may continue on treatment for up to 24 weeks if the doctor considers that they are benefiting from the treatment.
The Sponsor of the study is LEO Pharma A/S. Approximately 510 participants will take part in this study.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
22/SC/0033
Date of REC Opinion
8 Mar 2022
REC opinion
Further Information Favourable Opinion