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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

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Bausch Health

Status and phase

Completed
Phase 3

Conditions

Atopic Dermatitis

Treatments

Drug: IDP-124 Lotion
Drug: IDP-124 Vehicle Lotion

Study type

Interventional

Funder types

Industry

Identifiers

NCT03058783
V01-124A-302

Details and patient eligibility

About

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

Full 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

Enrollment

328 patients

Sex

All

Ages

2+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

328 participants in 2 patient groups

IDP-124 Lotion
Experimental group
Description:
IDP-124 Lotion, twice-daily application
Treatment:
Drug: IDP-124 Lotion
IDP-124 Vehicle Lotion
Active Comparator group
Description:
IDP-124 Vehicle Lotion, twice-daily application
Treatment:
Drug: IDP-124 Vehicle Lotion

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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