Safety and Efficacy of IDP-122 in the Treatment of Participants With Plaque Psoriasis

Bausch Health

Status and phase

Completed

Phase 3

Conditions

Plaque Psoriasis

Treatments

Drug: IDP-122 Vehicle Lotion

Drug: IDP-122 Lotion

Study type

Interventional

Funder types

Industry

Identifiers

NCT02515097

V01-122A-302

Details and patient eligibility

About

This study is to evaluate the safety and efficacy of a topical lotion when applied once daily to adult participants with moderate to severe plaque psoriasis (defined as an Investigator's Global Assessment [IGA] score of 3 or 4).

Full description

The objective of the study is to evaluate the safety and efficacy of topical IDP-122 Lotion when applied once daily to adult participants with moderate to severe plaque psoriasis. The intent of the study is specifically to evaluate the safety and efficacy of a once daily application of IDP-122 Lotion in comparison with vehicle.

Enrollment

213 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female, of any race, at least 18 years of age (inclusive).
Freely provides both verbal and written informed consent.
Has an area of plaque psoriasis appropriate for topical treatment that covers a body surface area (BSA) of at least 3%, but no more than 12%. The face, scalp, palms, soles, axillae, and intertriginous areas are to be excluded in this calculation.
Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study.
Has a clinical diagnosis of psoriasis at the Baseline visit with an IGA score of 3 or 4. (The face, scalp, palms, soles, axillae and intertriginous areas are to be excluded in this assessment).

Exclusion criteria

Has spontaneously improving or rapidly deteriorating plaque psoriasis or pustular psoriasis, as determined by the Investigator.
Presents with psoriasis that was treated with prescription medication and failed to respond to treatment, even partially or temporarily, as determined by the Investigator.
Presents with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the Investigator.
Is pregnant, nursing an infant, or planning a pregnancy during the study period.
Has received treatment with any investigational drug or device within 60 days or 5 drug half-lives (whichever is longer) prior to the Baseline visit or is concurrently participating in another clinical study with an investigational drug or device.