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

NCT03250624 | Completed Phase 2 Results

• 1 other identifier: RD.03.SPR.109696
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 5

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Eczema Area and Severity Index (EASI) Score at Day 43

  The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum), with the higher scores indicated the worse severity of AD. All missing values were imputed by Last Observation Carried Forward (LOCF).

  Baseline, Day 43

Secondary Outcomes (6)

• Percent Change From Baseline in EASI at Each Visit

  Baseline, Days 8,15, 22, 29, 36 and 43

• Percentage of Participants Who Achieved an Investigator Global Assessment (IGA) Score of 1 (Almost Clear) or 0 (Clear)

  Days 8, 15, 22, 29, 36 and 43

• Percent Change From Baseline in Total Sum Score (TSS) at Each Visit

  Baseline, Days 8, 15, 22, 29, 36 and 43

• Percent Change From Baseline in Modified Objective Scoring Atopic Dermatitis (SCORAD) at Each Visit

  Baseline, Days 8, 15, 22, 29, 36 and 43

• Change From Baseline in Pruritus Numerical Rating Scale (NRS) at Each Visit

  Baseline, Weeks 1, 2, 3, 4, 5 and 6

Study Arms (2)

CD5024 0.3% cream

EXPERIMENTAL

Drug: CD5024 0.3% cream

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

CD5024 0.3% cream 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.

Also known as: Ivermectin

CD5024 0.3% cream

Placebo 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.

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The participant was a male or female aged 18 to 60 years old inclusive at Screening.
• The participant presented with a total body surface area (tBSA) less than or equal to (\>=) 2 square meter (m\^2) at Screening.
• 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.
• Atopic dermatitis must be stable for at least one month before the screening visit (according to participant).
• 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.
• The participant had an overall Investigator's Global Assessment (IGA) score of 3 (moderate) at Day 1;

You may not qualify if:

• The participant was a pregnant female, is breastfeeding or intends to conceive a child during the study,
• 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.
• The participant presented with an acute flare of AD at Day 1.
• 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.
• The participant had a history of confounding skin condition (e.g. psoriasis, erythroderma) or a history of Netherton syndrome at Screening.
• The participant had a past history of serious persistent neurological disorders such as seizures, multiple sclerosis, or neurological signs or symptoms at Screening.

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (5)

Galderma Investigational Site (#8581)

Mississauga, Ontario, L5H 1G9, Canada

Location

Galderma Investigational Site (# 8338)

Richmond Hill, Ontario, L4B 1A5, Canada

Location

Galderma Investigational Site (#8587)

Richmond Hill, Ontario, L4C 9M7, Canada

Location

Galderma Investigational Site (# 8060)

Windsor, Ontario, N8W 5L7, Canada

Location

Galderma Investigational Site (#8089)

Montreal, Quebec, H2K 4L5, Canada

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Ivermectin

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Clinical Operations
• Organization: Galderma

Clinical.Studies@galderma.com

817 961 5000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2017
• First Posted: August 15, 2017
• Study Start: November 1, 2016
• Primary Completion: June 26, 2017
• Study Completion: June 26, 2017
• Last Updated: May 1, 2023
• Results First Posted: May 1, 2023

Record last verified: 2022-06

Locations

CA (5)