Overview

This trial is active, not recruiting.

Condition plaque psoriasis
Treatments idp-118 lotion, idp-118 vehicle lotion
Phase phase 3
Sponsor Valeant Pharmaceuticals International, Inc.
Collaborator Dow Pharmaceutical Sciences
Start date July 2015
End date October 2016
Trial size 210 participants
Trial identifier NCT02462122, NCT02615093, V01-118A-302

Summary

Safety and Efficacy of IDP-118 in the treatment of plaque psoriasis

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Lotion
idp-118 lotion Lotion
Lotion
(Active Comparator)
Vehicle Lotion
idp-118 vehicle lotion Vehicle
Lotion

Primary Outcomes

Measure
The percent of subjects with treatment success
time frame: 3 months

Eligibility Criteria

Male or female participants at least 18 years old.

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). 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.

Additional Information

Official title A Phase 3, Multicenter, Double-Blind, Randomized, Vehicle Controlled Clinical Study to Assess the Safety and Efficacy of IDP-118 in the Treatment of Plaque Psoriasis
Description A Phase 3, Multicenter, Double-Blind, Randomized, Vehicle Controlled Clinical Study to Assess the Safety and Efficacy of IDP-118 in the Treatment of Plaque Psoriasis
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Valeant Pharmaceuticals International, Inc..