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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03002571
Other study ID # V01-124A-301
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date July 24, 2018
Est. completion date April 14, 2020

Study information

Verified date April 2023
Source Bausch Health Americas, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric and Adult Subjects


Description:

A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Study to Evaluate the Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric and Adult Subjects


Recruitment information / eligibility

Status Completed
Enrollment 338
Est. completion date April 14, 2020
Est. primary completion date April 14, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years and older
Eligibility Key Inclusion Criteria: - Male or female at least 2 years of age and older - Written and verbal informed consent must be obtained; subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if subject reaches age of consent during the study they should be re-consented at the next study visit) - Nonimmunocompromized male or female who failed to respond adequately to other topical prescription treatment for AD or for whom those treatments are not advisable - Subjects must be willing to comply with study instructions and return to the clinic for required visits; subjects under the age of consent must be accompanied by the parent or legal guardian at the time of assent/consent signing Key Exclusion Criteria: - Females who are pregnant, breast feeding, or who wish to become pregnant during the study period - Active cutaneous bacterial or viral infection in any treatment area at Baseline (eg, clinically infected AD) - Sunburn, extensive scarring, or pigmented lesion(s) in any treatment area at Baseline, which would interfere with evaluations - History of confounding skin conditions, eg, psoriasis, rosacea, erythroderma, or ichthyosis (other than ichthyosis vulgaris)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
IDP-124 Lotion
IDP-124 Lotion, twice-daily application
IDP-124 Vehicle Lotion
IDP-124 Vehicle Lotion, twice-daily application

Locations

Country Name City State
United States Valeant Site 01 Fort Lauderdale Florida

Sponsors (1)

Lead Sponsor Collaborator
Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants Who Had at Least a 2-grade Reduction From Baseline at Week 6 in the Investigator Global Assessment (IGA) Scale and Had an IGA at Week 6 That Equated to "Clear" or "Almost Clear" Investigator Global Assessment (IGA) was determined based on evaluator-blinded evaluations of the inflammatory signs of atopic dermatitis. Evaluations were scored using a 5-point scale from clear (0) to severe (4), with higher numbers indicating worse scores. Baseline to Week 6
Secondary Percentage of Participants Who Had at Least a 2-grade Reduction From Baseline in the Investigator Global Assessment (IGA) Scale and Had an IGA That Equated to "Clear" or "Almost Clear" Investigator Global Assessment (IGA) was determined based on evaluator-blinded evaluations of the inflammatory signs of atopic dermatitis. Evaluations were scored using a 5-point scale from clear (0) to severe (4), with higher numbers indicating worse scores. Baseline to Week 10
Secondary Percentage of Participants Who Had Eczema Area Severity Index (EASI) 75 EASI 75 is defined as at least a 75% reduction in the Eczema Area Severity Index (EASI) score from Baseline. EASI is composite score based on the evaluated severity of 4 key signs of AD (i.e., erythema, infiltration/papulation, excoriation and lichenification), and the extent of disease in each of the 4 body regions (i.e., head/neck, trunk, upper limbs, and lower limbs). The area of involvement (affected by inflammation, not including dry skin) of each of the 4 body regions is determined and represented by a numeric coded value based on a scale from 0 to 6. The 4 body regions are assessed separately for each sign/symptom, and the average degree of severity of each sign in each of the 4 body parts is assigned a score of 0 (none) to 3 (severe) on a scale that allows half-unit increments. The EASI score ranges from 0 to 72, with higher scores being worse. Baseline to Week 10
Secondary Percentage of Participants Who Had at Least a 1 Grade Improvement From Baseline in the Severity of Pruritus Score and a Pruritus Score Equating to "None" or "Mild" Pruritis was assessed on a 4-point scale with 0 (none) to 3 (severe) and higher scores being worse. Baseline to Week 2
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