Overview

This trial is active, not recruiting.

Condition plaque psoriasis
Treatment idp-118 lotion
Phase phase 3
Sponsor Valeant Pharmaceuticals International, Inc.
Collaborator Dow Pharmaceutical Sciences
Start date July 2015
End date August 2017
Trial size 555 participants
Trial identifier NCT02462083, NCT02611349, V01-118A-303

Summary

The objective of this study is to evaluate the long-term safety of IDP-118 Lotion.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
halobetasol propionate [HP], tazarotene [Taz]
idp-118 lotion Tazarotene
Applied topically once daily

Primary Outcomes

Measure
The percent of subjects who experience a local skin reaction
time frame: up to 12 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 Body Surface Area (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 Investigators Global Assessment (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, Open Label Study to Evaluate the Long-Term Safety of IDP-118 Lotion in the Treatment of Plaque Psoriasis
Description This is a multicenter, open label study of the long-term safety of IDP-118 Lotion in subjects with plaque psoriasis. To be eligible for the study, subjects must be at least 18 years of age and have a clinical diagnosis of moderate to severe plaque psoriasis (defined as an Investigator's Global Assessment [IGA] score of 3 or 4).
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Valeant Pharmaceuticals International, Inc..