Dupilumab skin BArrier function and Lipidomics study in Atopic Dermatitis

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- Participant must be between 12 to 65 years of age (inclusive), at the time of signing the informed consent.
Atopic dermatitis patients:
- Male or female patients.
- Patients with AD diagnosis according to Hanifin and Rajka criteria at least 1 year before screening.
- IGA score of =3 at screening (on the 0-4 scale).
- Patients with moderate to severe atopic dermatitis that are eligible to be treated with dupilumab according to product monograph
- Patients with AD must have active lesions on the upper limbs or lower limbs, with severity for lesion erythema or edema/papulation =2 at screening on the 0-3 scale of the ISS.
- Participants should have a non-lesional (normal looking) skin area 4 cm from the edge of the lesional area. If unable to identify non-lesional skin 4 cm from the lesional area, it is acceptable to identify normal looking skin as close to the lesion as possible.
Healthy volunteers:
- Age and gender matched to a selected AD patient. Adolescents aged 12 to 17 years will be matched by post puberty status, and adults aged 18 to 65 years will be matched by age as close as possible within 10 years of age..
Are the trial subjects under 18? yes
Number of subjects for this age range: 24
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Previous treatment with dupilumab within 6 months prior to screening
- Skin conditions other than AD that can confound assessments in the area of TEWL assessments in the opinion of the investigator (ie, skin atrophy, ichthyosis, Netherton syndrome, severe photo damage).
- Cracked, crusted, oozing, or bleeding AD lesions in the designated lesional assessment area leaving insufficient skin that is adequate for TEWL assessments.
- Ocular disorder that in the opinion of the investigator could adversely affect the individual’s risk for study participation. Examples include -but are not limited to- individuals with a history of active cases of herpes keratitis; Sjogren’s syndrome, keratoconjunctivitis sicca or dry eye syndrome that require daily use of supplemental lubrication; or individuals with ocular conditions that require the use of ocular corticosteroids or cyclosporine.

- Healthy volunteers with a personal history of an atopic condition.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluate changes in skin barrier function with transepidermal water loss (TEWL) assessed after skin tape stripping (STS) in pre-defined lesional skin in patients with moderate to severe atopic dermatitis (AD) treated with dupilumab;Secondary Objective: - Evaluate changes in skin barrier function with TEWL assessed after STS in pre-defined lesional and non-lesional skin in patients with moderate to severe AD treated with dupilumab in reference to normal skin of healthy volunteers.<br>- Evaluate time course of skin barrier function with TEWL assessed before and after STS in pre-defined lesional and non-lesional skin in patients with moderate to severe AD treated with dupilumab in reference to normal skin of healthy volunteers<br>;Primary end point(s): Percent change in TEWL after 5 STS on lesional skin in AD patients ; Percent change from baseline in TEWL after 5 STS assessed on lesional skin in AD patients;Timepoint(s) of evaluation of this end point: Baseline to week 16

Secondary Outcome Measures

Name	Time	Method

Related Trials

Dupilumab-PEdiatric skin barrier function and LIpidomics STudy in patients with Atopic Dermatitis

Phase 1

Sanofi Aventis Recherche & Developpement

Updated 10/13/2020