Topically Applied IDP-118 Lotion and HP Monad Lotion in Subjects With Moderate to Severe Plaque Psoriasis

Bausch Health

Status and phase: Completed; Phase 1

Conditions: Psoriasis

Treatments: Drug: Tazorac Cream; Drug: Ultravate Cream; Drug: IDP-118 Lotion; Drug: HP Monad Lotion

Study type: Interventional

Funder types: Industry

Identifiers

NCT03058744

V01-118A-501

Details and patient eligibility

About

Suppression Potential of Topically Applied IDP-118 Lotion and HP Monad Lotion in Subjects with Moderate to Severe Plaque Psoriasis.

Full description

A Phase 1b Open-Label, Randomized Study Evaluating the Absorption and Systemic Pharmacokinetics and HPA Axis Suppression Potential of Topically Applied IDP-118 Lotion and HP Monad Lotion in Subjects with Moderate to Severe Plaque Psoriasis.

Enrollment: 94 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Male or Female of any race, at least 18 years old of age (inclusive)
• Freely provides both written and oral informed consent.
• Has a clinical diagnosis of psoriasis at the Baseline visit with an Investigator's Global Assessment Score of 3 or 4. The face, scalp ,axillae, and intertriginous areas are to be excluded in this calculation.
• Has an area of plaque psoriasis for topical treatment that involves a BSA of at least 20%.
• The willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study.

Key Exclusion Criteria:

• Has spontaneously improving or rapidly deteriorating plaque psoriasis or postural psoriasis, as determined by the investigator.
• Presents with psoriasis that was treated with prescription medication and failed to respond to presents).
• Has a history of adrenal disease.
• Presents with any other concurrent skin conditions that could interfere with the evaluation of the treatment areas, as determined by the investigator.
• Is pregnant, nursing, or planning pregnancy during the study period.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 4 patient groups

IDP-118 Lotion

Experimental group

Description:

8 Weeks

Treatment:

Drug: IDP-118 Lotion

HP Monad Lotion

Experimental group

Description:

8 Weeks

Treatment:

Drug: HP Monad Lotion

Ultravate Cream

Active Comparator group

Description:

2 Weeks

Treatment:

Drug: Ultravate Cream

Tazorac Cream

Active Comparator group

Description:

4 Weeks

Treatment:

Drug: Tazorac Cream