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

Launched by BAUSCH HEALTH AMERICAS, INC. · May 24, 2016

Keywords

ClinConnect Summary

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

Gender

ALL

Eligibility 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.