Safety and Efficacy of IDP-118 Lotion to Ultravate® in the Treatment of Plaque Psoriasis

Bausch Health

Status and phase: Completed; Phase 2

Conditions: Psoriasis

Treatments: Drug: Ultravate Cream; Drug: IDP-118 Vehicle Lotion; Drug: IDP-118 Vehicle Cream; Drug: IDP-118 Lotion

Study type: Interventional

Funder types: Industry

Identifiers

NCT02785172

V01-118A-203

Details and patient eligibility

About

Safety and Efficacy of IDP-118 Lotion to Ultravate® Cream, in the Treatment of Plaque Psoriasis

Full description

A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study to Compare the Safety and Efficacy of IDP-118 Lotion to Ultravate® Cream, in the Treatment of Plaque Psoriasis

Enrollment: 154 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key 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 BSA (Body Surface Area) 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 (Investigators Global Assessment) score of 3 or 4. (The face, scalp, palms, soles, axillae, and intertriginous areas are to be excluded in this assessment, if psoriasis is present.)
• If female and of childbearing potential, must have a negative urine and serum pregnancy test at the Screening visit and negative urine pregnancy at Baseline visit prior to randomization.
• Subject is willing to comply with study instructions and return to the clinic for required visits.

Key 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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154 participants in 4 patient groups

IDP-118 Lotion

Experimental group

Description:

Lotion

Treatment:

Drug: IDP-118 Lotion

Ultravate Cream

Active Comparator group

Description:

Cream

Treatment:

Drug: Ultravate Cream

IDP-118 Vehicle Lotion

Active Comparator group

Description:

Lotion

Treatment:

Drug: IDP-118 Vehicle Lotion

IDP-118 Vehicle Cream

Active Comparator group

Description:

Cream

Treatment:

Drug: IDP-118 Vehicle Cream