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

• Status: Completed
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bausch Health Americas, Inc.; Valeant Pharmaceuticals International, Inc.
• Treatments: Clobetasol; Halobetasol; Tazarotene

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.