- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07323394
Real-World Study on the Impact of Atopic Dermatitis From a Caregiver Perspective
January 22, 2026 updated by: PeriPharm
This study will address this gap by providing comprehensive data on disease burden from a caregiver perspective in a Canadian population, ultimately supporting improved clinical decision-making and healthcare resource allocation.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jean Lachaine, Ph. D.
- Phone Number: 514-731-8207
- Email: jean.lachaine@peripharm.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Caregiver of a child aged ≥2 to ≤11 years with mild to moderate atopic dermatitis
Description
Inclusion Criteria:
- Aged ≥18 years;
- Caregiver of a child aged ≥2 to ≤11 years with mild to moderate atopic dermatitis;
- Able to read and understand French or English;
- Willing and able to provide written informed consent.
Exclusion Criteria:
- Caregivers whose child has been diagnosed with severe atopic dermatitis ;
- Caregivers whose child is currently treated with oral or topical Janus Kinase Inhibitor);
- Caregivers whose child is currently participating in a clinical trial for atopic dermatitis;
- Other parent or caregiver within the household of the child with atopic dermatitis.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Caregiver of child with atopic dermatitis
Caregiver of a child aged ≥2 to ≤11 years with mild to moderate atopic dermatitis
|
No specific intervention is assess in this study.
Observational cohort.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To estimate work productivity loss in caregivers of children with mild or moderate atopic dermatitis.
Time Frame: At recruitment
|
Using the Work Productivity and Activity Impairment questionnaire.
This questionnaire provides a quantitative measure of impairment over the last 7 days and includes four metrics: absenteeism (work time missed because of health issues during the past 7 days), presenteeism (impairment while working due to health issues during the past 7 days), overall work productivity loss (combination of absenteeism and presenteeism), and activity impairment.
|
At recruitment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To estimate family burden of mild to moderate atopic dermatitis in children, as reported by caregivers
Time Frame: At recruitment
|
The Dermatitis Family Impact (DFI) questionnaire will be administered to caregivers to evaluate the family burden of pediatric atopic dermatitis.
The DFI is a validated, 10-item instrument specifically developed for atopic dermatitis, covering domains such as housework, feeding, sleep, leisure activities, time spent shopping, expenditure, physical fatigue, emotional distress, relationships, helping with treatment, with a 7-day recall period.
Each item is scored on a 4-point Likert scale ("Not at all = 0" to "Very much = 3"), with higher total scores indicating greater impact
|
At recruitment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
January 1, 2026
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
July 1, 2026
Study Registration Dates
First Submitted
December 22, 2025
First Submitted That Met QC Criteria
December 22, 2025
First Posted (Actual)
January 7, 2026
Study Record Updates
Last Update Posted (Actual)
January 23, 2026
Last Update Submitted That Met QC Criteria
January 22, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PROxy96AD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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