Ignite Creation Date:
2025-12-24 @ 12:09 PM
Ignite Modification Date:
2025-12-29 @ 10:09 PM
Study NCT ID:
NCT06983561
Status:
RECRUITING
Last Update Posted:
2025-08-28
First Post:
2025-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Description of the Population With Moderate to Severe Atopic Dermatitis, Treated by Systemic Treatments and Needs Regarding Emollients
Sponsor:
Pierre Fabre Dermo Cosmetique
Organization:
Study Overview
Official Title:
An Exploratory and Proof of Concept Study to Characterize and Describe the Population of Subjects Suffering From Moderate to Severe Atopic Dermatitis, Treated and Controlled by Systemic Treatments and Their Needs and Expectations Regarding the Use of Emollient
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Atopic dermatitis (AD) is a common chronic inflammatory skin disease, affecting both children (15- 20%) and adults (2-5%). The pathogenesis of AD is complex and multifactorial, including skin barrier dysfunction and immune dysregulation. AD often requires a long management and has a major impact on quality of life. For mild to moderate disease, first-line treatment involves topical therapies including corticosteroids and calcineurin inhibitors. Patients with more severe and refractory symptoms require systemic treatments as phototherapy, conventional systemic treatments (cyclosporine, methotrexate…), biologics and JAK-inhibitors.
Regardless of the severity of the disease, additional basic topical treatment with emollient is the mainstay of the management. Emollients, commonly referred to as moisturizing creams are well known for their role in moisture retention, barrier repair and symptom control in AD.
Publications on emollient in atopic dermatitis are numerous but there are limited data on how patients with AD treated by systemic treatment use and evaluate emollients.
The aim of this study is to characterize and describe the population of subjects suffering from moderate to severe AD, treated and controlled by systemic treatments in terms of pathology, the state of their skin at this stage of their systemic treatment (controlled period), their habits, needs and expectations regarding the use of emollient.
This study will be conducted as an exploratory, proof of concept, international, multicentric study in adult subjects suffering from moderate to severe AD, treated and controlled by systemic treatments.
2 visits are planned: Visit 1 (Day 1): Inclusion Visit 2 (from Day 2 to Day 8): End-of-study visit - remote visit for subject's questionnaire filling The maximal duration of participation for a subject is 8 days.
Regardless of the severity of the disease, additional basic topical treatment with emollient is the mainstay of the management. Emollients, commonly referred to as moisturizing creams are well known for their role in moisture retention, barrier repair and symptom control in AD.
Publications on emollient in atopic dermatitis are numerous but there are limited data on how patients with AD treated by systemic treatment use and evaluate emollients.
The aim of this study is to characterize and describe the population of subjects suffering from moderate to severe AD, treated and controlled by systemic treatments in terms of pathology, the state of their skin at this stage of their systemic treatment (controlled period), their habits, needs and expectations regarding the use of emollient.
This study will be conducted as an exploratory, proof of concept, international, multicentric study in adult subjects suffering from moderate to severe AD, treated and controlled by systemic treatments.
2 visits are planned: Visit 1 (Day 1): Inclusion Visit 2 (from Day 2 to Day 8): End-of-study visit - remote visit for subject's questionnaire filling The maximal duration of participation for a subject is 8 days.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: