Overview
Safety and Efficacy of IDP-118 Lotion to Ultravate® in the Treatment of Plaque Psoriasis
Status:
Completed
Completed
Trial end date:
2017-01-01
2017-01-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
Safety and Efficacy of IDP-118 Lotion to Ultravate® Cream, in the Treatment of Plaque PsoriasisPhase:
Phase 2Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Bausch Health Americas, Inc.
Valeant Pharmaceuticals International, Inc.Treatments:
Clobetasol
Halobetasol
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.