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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

NCT05214326 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 187

Last updated 2023-11-29

No results posted yet for this study

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.

Conditions

  • Dermatitis Atopic

Sponsors & Collaborators

Principal Investigators

  • Trial Transparency Clinical Sciences & Operations · Sanofi

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-18
Primary Completion
2023-03-21
Completion
2023-03-21

Countries

  • Kuwait
  • Saudi Arabia
  • United Arab Emirates

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05214326 on ClinicalTrials.gov