Safety and Efficacy of CD5024 0.3% Cream in Subjects With Atopic Dermatitis

Galderma

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: Placebo; Drug: CD5024 0.3% cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT03250624

RD.03.SPR.109696

Details and patient eligibility

About

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.

Full description

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

Enrollment: 63 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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63 participants in 2 patient groups, including a placebo group

CD5024 0.3% cream

Experimental group

Treatment:

Drug: CD5024 0.3% cream

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo