Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric and Adult Subjects
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03058783 |
Recruitment Status :
Completed
First Posted : February 23, 2017
Last Update Posted : May 12, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Atopic Dermatitis | Drug: IDP-124 Lotion Drug: IDP-124 Vehicle Lotion | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 328 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | August 14, 2018 |
Actual Primary Completion Date : | May 12, 2020 |
Actual Study Completion Date : | May 12, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: IDP-124 Lotion
Lotion
|
Drug: IDP-124 Lotion
Lotion
Other Name: IDP-124 |
Active Comparator: IDP-124 Vehicle Lotion
Vehicle
|
Drug: IDP-124 Vehicle Lotion
Lotion
Other Name: Vehicle |
- Percent of Subjects with treatment success at Week 6 [ Time Frame: 6 weeks ]Treatment success will be defined by using a 5-Point Investigator Global Assessment (IGA) scale ranging from clear to severe; with success being defined as a 2 point improvement from baseline.

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Ages Eligible for Study: | 2 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03058783
United States, California | |
Valeant Site 05 | |
Fremont, California, United States, 94536 |
Study Director: | Anya Loncaric | Valeant Pharmaceitucals |
Responsible Party: | Bausch Health Americas, Inc. |
ClinicalTrials.gov Identifier: | NCT03058783 |
Other Study ID Numbers: |
V01-124A-302 |
First Posted: | February 23, 2017 Key Record Dates |
Last Update Posted: | May 12, 2021 |
Last Verified: | May 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Dermatitis, Atopic Dermatitis Eczema Skin Diseases Skin Diseases, Genetic |
Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |