Dupilumab Skin Barrier Function Study in Atopic Dermatitis

Part of paid clinical trials in Denver, Colorado.

Sponsor
Sanofi
Study ID
NCT04447417
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Dupilumab SAR231893 — DRUG
    Pharmaceutical form:solution for injection Route of administration: subcutaneous

Study Details

Primary Objective: \- Evaluate changes in skin barrier function with transepidermal water loss (TEWL) assessed after skin tape stripping (STS) in pre-defined lesional skin in participants with moderate to severe atopic dermatitis (AD) treated with dupilumab. Secondary Objectives: * Evaluate changes in skin barrier function with TEWL assessed after STS in pre-defined lesional and non-lesional skin in participants with moderate to severe AD treated with dupilumab in reference to normal skin of healthy volunteers. * Evaluate time course of skin barrier function with TEWL assessed before and after STS in pre-defined lesional and non-lesional skin in participants with moderate to severe AD treated with dupilumab in reference to normal skin of healthy volunteers.

Key Dates

Start date
Jul 16, 2020
Status verified
Sep 2025
Primary completion
Jun 17, 2021
Completion
Jun 17, 2021

Study Design

Enrollment
52 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Healthy Volunteer
    Healthy volunteers with age, gender, location of targeted skin lesion area and study site matched to a selected atopic dermatitis (AD) participants, received no treatment, but were monitored in similar way as like enrolled AD participants.
  • Experimental: Atopic Dermatitis Patients
    Participants with moderate to severe AD and aged 18 years and older received dupilumab 600 milligrams (mg) (loading dose) subcutaneous (SC) injection on Day 1, followed by dupilumab 300 mg SC injection every 2 weeks (Q2W) through Week 14 (i.e., at Day 15, 29, 43, 57 and 85). Participants aged greater than or equal to (\>=) 12 to less than (\<) 18 years received treatment based on their body weight: \<60 kilograms (kg) and \>=60 kg - received dupilumab 400 mg and 600 mg (loading dose) SC injection on Day 1, respectively, followed by dupilumab 200 mg and 300 mg SC injection Q2W through Week 14 (i.e., at Day 15, 29, 43, 57 and 85).

Primary Outcome Measure

Percent Change From Baseline in Transepidermal Water Loss After 5 Skin Tape Stripping (STS) on Lesional Skin (LS) in AD Patients at Week 16 [ Time Frame: Baseline, Week 16 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Investigational Site Number 8400001DenverColorado80206-

Find similar trials in Denver, CO

By condition
Atopic dermatitis / eczema
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Investigational· Denver, CO

Related Studies