Overview

Long-Term Safety of IDP-118 Lotion in the Treatment of Plaque Psoriasis

Status:
Completed
Trial end date:
2017-04-24
Target enrollment:
0
Participant gender:
All
Summary
The objective of this study is to evaluate the long-term safety of IDP-118 lotion.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bausch Health Americas, Inc.
Valeant Pharmaceuticals International, Inc.
Collaborator:
Dow Pharmaceutical Sciences
Treatments:
Halobetasol
Tazarotene
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 Body
Surface Area (BSA) of at least 3 percent (%), 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.