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

NCT03058783 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: V01-124A-302
• Study Type: interventional
• Target: 328
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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"

  Baseline to Week 10

• Percentage of Participants Who Had Eczema Area Severity Index (EASI) 75

  Baseline to Week 10

• 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"

  Baseline to Week 2

Study Arms (2)

IDP-124 Lotion

EXPERIMENTAL

IDP-124 Lotion, twice-daily application

Drug: IDP-124 Lotion

IDP-124 Vehicle Lotion

ACTIVE COMPARATOR

IDP-124 Vehicle Lotion, twice-daily application

Drug: IDP-124 Vehicle Lotion

Interventions

IDP-124 Lotion DRUG

IDP-124 Lotion, twice-daily application

IDP-124 Lotion

IDP-124 Vehicle Lotion DRUG

IDP-124 Vehicle Lotion, twice-daily application

IDP-124 Vehicle Lotion

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• History or presence of:
• basal cell carcinoma of skin effectively treated more than 2 years ago
• carcinoma of cervix effectively treated more than 5 years ago
• immunological deficiencies or diseases, HIV, or serious recurrent infection
• clinically significant severe renal insufficiency or severe hepatic disorders
• Current or recent serious infection

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (1)

Valeant Site 05

Fremont, California, 94536, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

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

Results Point of Contact

• Title: Study Director
• Organization: Bausch Health Americas, Inc

susan.harris@bauschhealth.com

19083009920

Study Officials

• Anya Loncaric

  Valeant Pharmaceitucals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2016
• First Posted: February 23, 2017
• Study Start: August 14, 2018
• Primary Completion: May 12, 2020
• Study Completion: May 12, 2020
• Last Updated: May 8, 2023
• Results First Posted: May 8, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)