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

A Phase 2, Multicenter, Double-Blind, Randomized, Vehicle Controlled Clinical Study to Assess the Safety and Efficacy of IDP 118 in the Treatment of Plaque Psoriasis

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

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.

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.