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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03058783
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

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

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: IDP-124 Lotion Drug: IDP-124 Vehicle Lotion Phase 3

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 348 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
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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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
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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Karen Villaluna 9085413279 karen.villaluna@valeant.com
Contact: Zach Pfauth 9085413279 zachary.pfauth@valeant.com

Locations
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United States, California
Valeant Site 05 Recruiting
Fremont, California, United States, 94536
Sponsors and Collaborators
Bausch Health Americas, Inc.
Investigators
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Study Director: Anya Loncaric Valeant Pharmaceitucals
More Information
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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: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
 Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases