Clinical trial NCT03058783: Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric and Adult Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2017-02-23
Enrollment: 328
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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

Eligibility criteria: 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

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)
* 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

Primary outcomes:
measure: 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"
timeFrame: Baseline to Week 6
Secondary outcomes:
measure: 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"
timeFrame: Baseline to Week 10
measure: Percentage of Participants Who Had Eczema Area Severity Index (EASI) 75
timeFrame: Baseline to Week 10
measure: 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"
timeFrame: Baseline to Week 2
Other outcomes:
Locations:
city: Fremont
country: United States
facility: Valeant Site 05
state: California
Study officials:
affiliation: Valeant Pharmaceitucals
name: Anya Loncaric
role: STUDY_DIRECTOR
References: