Safety and Efficacy of IDP 118 in the Treatment of Plaque Psoriasis

Bausch Health

Status and phase: Completed; Phase 2

Conditions: Plaque Psoriasis

Treatments: Drug: IDP-118 Vehicle Lotion; Drug: IDP-118 Lotion; Drug: IDP-118 Monad Taz Lotion; Drug: IDP-118 Monad HP Lotion

Study type: Interventional

Funder types: Industry

Identifiers

NCT02045277

V01-118A-201

Details and patient eligibility

About

The objective of the study is to evaluate the safety and efficacy of a topical lotion

Full description

The objective of the study is to evaluate the safety and efficacy of a topical lotion when applied once daily to adult subjects with moderate to severe plaque psoriasis.

Enrollment: 212 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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 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, if psoriasis is present).

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: Factorial Assignment

Masking: Quadruple Blind

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212 participants in 4 patient groups

IDP-118 Lotion

Experimental group

Description:

halobetasol propionate \[HP\], tazarotene \[Taz\]

Treatment:

Drug: IDP-118 Lotion

IDP-118 Monad HP Lotion

Active Comparator group

Description:

HP

Treatment:

Drug: IDP-118 Monad HP Lotion

IDP-118 Monad Taz Lotion

Active Comparator group

Description:

Taz

Treatment:

Drug: IDP-118 Monad Taz Lotion

IDP-118 Vehicle Lotion

Active Comparator group

Description:

Vehicle

Treatment:

Drug: IDP-118 Vehicle Lotion