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

NCT ID: NCT03250624

Last Updated: 2023-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-01
• Study Completion Date: 2017-06-26

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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

CD5024 0.3% cream

Group Type: EXPERIMENTAL

CD5024 0.3% cream

Intervention Type: DRUG

Participants applied CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 milligrams per centimeter square (mg/cm\^2) once daily for 6 weeks.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Participants applied placebo matched to CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm\^2 once daily for 6 weeks.

Interventions

CD5024 0.3% cream

Participants applied CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 milligrams per centimeter square (mg/cm\^2) once daily for 6 weeks.

Intervention Type: DRUG

Placebo

Participants applied placebo matched to CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm\^2 once daily for 6 weeks.

Intervention Type: DRUG

Other Intervention Names

Ivermectin

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Galderma R&D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Galderma Investigational Site (#8581)

Mississauga, Ontario, Canada

Galderma Investigational Site (# 8338)

Richmond Hill, Ontario, Canada

Galderma Investigational Site (#8587)

Richmond Hill, Ontario, Canada

Galderma Investigational Site (# 8060)

Windsor, Ontario, Canada

Galderma Investigational Site (#8089)

Montreal, Quebec, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

RD.03.SPR.109696

Identifier Type: -

Identifier Source: org_study_id