Clinical Trials Directory

Trials / Completed

CompletedNCT05214326

A Study to Assess the Disease Control of Moderate to Severe Atopic Dermatitis in Male and Female Participants of Atleast 12 Years Old Receiving Dupilumab Injections in Gulf Countries

A Real-World Study to Assess the Disease Control of Moderate to Severe Atopic Dermatitis in Patients Receiving Dupilumab Therapy, With Atopic Dermatitis Control Tool in Gulf Countries

Status
Completed
Phase
Study type
Observational
Enrollment
187 (actual)
Sponsor
Sanofi · Industry
Sex
All
Age
12 Years
Healthy volunteers
Not accepted

Summary

Primary objective: To assess the disease control of moderate to severe atopic dermatitis in patients aged 12 years and above treated with dupilumab therapy using Atopic Dermatitis Control Tool (ADCT) after 24 weeks of treatment. Secondary objectives: * To figure the proportion of patients with reduction of ADCT score by 5 points after 4, 12, and 24 weeks of treatment. * To figure the proportion of patients with ADCT score less than 7 at weeks 4, 12, and 24. * Assess the effectiveness of dupilumab in moderate to severe atopic dermatitis (AD) patients, using the severity score as routine practice SCORing Atopic Dermatitis (SCORAD). * To describe comorbidities related to type 2 inflammation. * To characterize the safety profile of dupilumab in the local Gulf population. * To evaluate treatment satisfaction in the local Gulf population.

Detailed description

24 weeks

Conditions

Timeline

Start date
2022-01-18
Primary completion
2023-03-21
Completion
2023-03-21
First posted
2022-01-28
Last updated
2023-11-29

Locations

3 sites across 3 countries: Kuwait, Saudi Arabia, United Arab Emirates

Source: ClinicalTrials.gov record NCT05214326. Inclusion in this directory is not an endorsement.