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COMPLETED
NCT05355818
PHASE3

Efficacy and Safety of Delgocitinib Cream in Adolescents 12-17 Years of Age With Moderate to Severe Chronic Hand Eczema

Sponsor: LEO Pharma

View on ClinicalTrials.gov

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

Interventions

DRUG

Delgocitinib

Cream for topical application

DRUG

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