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Efficacy and Safety of Delgocitinib Cream in Adolescents 12-17 Years of Age With Moderate to Severe Chronic Hand Eczema
Sponsor: LEO Pharma
Summary
The purpose of this trial is to test if delgocitinib cream is effective in treating chronic hand eczema (CHE) and to find out what side effects it may have compared with a cream vehicle with no active medical ingredient in adolescents aged 12-17 years. At each visit to the clinic, the doctor will assess the severity and extent of CHE, and during the trial, the adolescents will assess their CHE signs and symptoms as well as quality of life. The trial will last up to 22 weeks and has a 1-4 week screening period, a 16-week treatment period and a 2- week follow-up period. During the treatment period, each adolescent participant will use either the delgocitinib cream or cream vehicle twice daily.
Official title: A Phase 3 Clinical Trial to Evaluate Efficacy and Safety of Twice-daily Applications of Delgocitinib Cream 20 mg/g Compared With Cream Vehicle for a 16-week Treatment Period in Adolescents 12-17 Years of Age With Moderate to Severe Chronic Hand Eczema (DELTA TEEN)
Key Details
Gender
All
Age Range
12 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
98
Start Date
2022-07-14
Completion Date
2024-12-17
Last Updated
2026-05-04
Healthy Volunteers
No
Conditions
Interventions
Delgocitinib
Cream for topical application
Cream vehicle
The cream vehicle is similar to the delgocitinib cream except that it does not contain any active medical ingredient.
Locations (37)
LEO Pharma investigational site
Darlinghurst, Australia
LEO Pharma investigational site
Mitcham, Australia
LEO Pharma investigational site
Phillip, Australia
LEO Pharma investigational site
Woolloongabba, Australia
LEO Pharma investigational site
Brussels, Belgium
LEO Pharma investigational site
Ghent, Belgium
LEO Pharma investigational site
Gilly, Belgium
LEO Pharma investigational site
Liège, Belgium
LEO Pharma investigational site
Edmonton, Canada
LEO Pharma investigational site
Fredericton, Canada
LEO Pharma investigational site
Kingston, Canada
LEO Pharma investigational site
Montreal, Canada
LEO Pharma investigational site
Red Deer, Canada
LEO Pharma investigational site
St. John's, Canada
LEO Pharma investigational site
Toronto, Canada
LEO Pharma investigational site
Winnipeg, Canada
LEO Pharma investigational site
Martigues, Bouches-du-Rhône, France
LEO Pharma investigational site
Nice, France
LEO Pharma investigational site
Reims, France
LEO Pharma investigational site
Toulouse, France
LEO Pharma investigational site
Chorzów, Poland
LEO Pharma investigational site
Krakow, Poland
LEO Pharma investigational site
Krakow, Poland
LEO Pharma investigational site
Krakow, Poland
LEO Pharma investigational site
Warsaw, Poland
LEO Pharma investigational site
Wroclaw, Poland
LEO Pharma investigational site
Alicante, Spain
LEO Pharma investigational site
Barcelona, Spain
LEO Pharma investigational site
Cadiz, Spain
LEO Pharma investigational site
Esplugues de Llobregat, Spain
LEO Pharma investigational site
Fuenlabrada, Spain
LEO Pharma investigational site
Granada, Spain
LEO Pharma investigational site
Ipswich, United Kingdom
LEO Pharma investigational site
Kings Lynn, United Kingdom
LEO Pharma investigational site
Lincoln, United Kingdom
LEO Pharma investigational site
London, United Kingdom
LEO Pharma investigational site
Walsall, United Kingdom