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

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

Completed

Open to: ALL

Age: 12.0 - 17.0

Medical Conditions

Eczema


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


The purpose of this trial is to test if delgocitinib cream is effective at treating chronic hand eczema (CHE) and what side effects it may have, in children aged 12-17. There will be a range of assessments that rate the severity and extent of CHE symptoms, general health and quality of life.

Delgocitinib is a cream that suppresses specific processes in the body's response to diseases like CHE, such as inflammation.

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 child will use either delgocitinib cream or a cream vehicle twice a day. Which cream each child receives is chosen randomly by a computer. The cream vehicle is made of the same ingredients as the delgocitinib cream except for the active medical ingredient. There will be 8 visits with the trial doctor.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Jul 2022 Dec 2024

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Cream for topical application

Intervention Arm Group : Delgocitinib cream;

Intervention Type : DRUG
Intervention Description : The cream vehicle is similar to the delgocitinib cream except that it does not contain any active medical ingredient.

Intervention Arm Group : Cream vehicle;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • LEO Pharma investigational site
    Ipswich
    IP4 5PD
  • LEO Pharma investigational site
    King's Lynn
    PE30 4ET
  • LEO Pharma investigational site
    London
    SW10 9NH
  • Leo Pharma Investigational site
    Lincoln
    LN2 5QY
  • LEO Pharma investigational site
    Walsall
    WS2 9PS


The study is sponsored by LEO Pharma




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Read full details for Trial ID: NCT05355818
Last updated 22 January 2025

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