Clinical trial NCT03250624: Safety and Efficacy of CD5024 0.3% Cream in Subjects With Atopic Dermatitis
Official title: Safety and Efficacy of CD5024 0.3% Cream in Subjects With Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2017-08-15
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Exploratory, multi-centric, randomized, vehicle-controlled, investigator-blind, parallel group study, involved participants with chronic lesions of Atopic Dermatitis (AD) to evaluate the local and systemic safety of CD5024 0.3% cream over a 6-week treatment period compared to its vehicle.

Detailed description: Study application was performed once daily, 7 days a week for 6 weeks.

Eligibility criteria: Inclusion Criteria:

1. The participant was a male or female aged 18 to 60 years old inclusive at Screening.
2. The participant presented with a total body surface area (tBSA) less than or equal to (\>=) 2 square meter (m\^2) at Screening.
3. The participant had atopic dermatitis for at least 6 months prior to Day 1. The clinical diagnosis of atopic dermatitis must be confirmed with the criteria of Hanifin and Rajka at the screening visit.
4. Atopic dermatitis must be stable for at least one month before the screening visit (according to participant).
5. The participant had a Body Surface Area (BSA) affected by AD ranging from 1% inclusive to 10% inclusive at Day 1, excluding scalp and genitals.
6. The participant had an overall Investigator's Global Assessment (IGA) score of 3 (moderate) at Day 1;

Exclusion Criteria:

1. The participant was a pregnant female, is breastfeeding or intends to conceive a child during the study,
2. The participant had any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with the interpretation of the clinical trial results (e.g. extensive scaring or pigmented lesion in a treated area), and/or put the participant at significant risk according to Investigator's judgment if he/she participates in the clinical trial (e.g. active cancer, AIDS, insulin-dependent diabetes...) at Screening or Day 1.
3. The participant presented with an acute flare of AD at Day 1.
4. The participant had active cutaneous bacterial or viral infection in any treated area at baseline (e.g. clinically infected AD) at Screening or Day 1.
5. The participant had a history of confounding skin condition (e.g. psoriasis, erythroderma) or a history of Netherton syndrome at Screening.
6. The participant had a past history of serious persistent neurological disorders such as seizures, multiple sclerosis, or neurological signs or symptoms at Screening.

Primary outcomes:
measure: Change From Baseline in Eczema Area and Severity Index (EASI) Score at Day 43
timeFrame: Baseline, Day 43
Secondary outcomes:
measure: Percent Change From Baseline in EASI at Each Visit
timeFrame: Baseline, Days 8,15, 22, 29, 36 and 43
measure: Percentage of Participants Who Achieved an Investigator Global Assessment (IGA) Score of 1 (Almost Clear) or 0 (Clear)
timeFrame: Days 8, 15, 22, 29, 36 and 43
measure: Percent Change From Baseline in Total Sum Score (TSS) at Each Visit
timeFrame: Baseline, Days 8, 15, 22, 29, 36 and 43
measure: Percent Change From Baseline in Modified Objective Scoring Atopic Dermatitis (SCORAD) at Each Visit
timeFrame: Baseline, Days 8, 15, 22, 29, 36 and 43
measure: Change From Baseline in Pruritus Numerical Rating Scale (NRS) at Each Visit
timeFrame: Baseline, Weeks 1, 2, 3, 4, 5 and 6
measure: Change From Baseline in Pruritus Verbal Rating Scale (VRS) Score at Day 43
timeFrame: Baseline, Day 43
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: Galderma Investigational Site (#8581)
state: Ontario
city: Richmond Hill
country: Canada
facility: Galderma Investigational Site (# 8338)
state: Ontario
city: Richmond Hill
country: Canada
facility: Galderma Investigational Site (#8587)
state: Ontario
city: Windsor
country: Canada
facility: Galderma Investigational Site (# 8060)
state: Ontario
city: Montreal
country: Canada
facility: Galderma Investigational Site (#8089)
state: Quebec
Study officials:
References: