Clinical trial NCT02785172: Safety and Efficacy of IDP-118 Lotion to Ultravate® in the Treatment of Plaque Psoriasis
Official title: A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study to Compare the Safety and Efficacy of IDP-118 Lotion to Ultravate® in the Treatment of Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2016-05-27
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Safety and Efficacy of IDP-118 Lotion to Ultravate® Cream, in the Treatment of Plaque Psoriasis

Detailed description: 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

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.

Primary outcomes:
measure: Percent of Subjects With Treatment Success
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Fullerton
country: United States
facility: Valeant Site 12
state: California
city: La Mesa
country: United States
facility: Valeant Site 04
state: California
city: San Diego
country: United States
facility: Valeant Site 03
state: California
city: San Diego
country: United States
facility: Valeant Site 09
state: California
city: Lauderdale Lakes
country: United States
facility: Valeant Site 05
state: Florida
city: Miami
country: United States
facility: Valeant Site 02
state: Florida
city: Fridley
country: United States
facility: Valeant Site 07
state: Minnesota
city: Chapel Hill
country: United States
facility: Valeant Site 08
state: North Carolina
city: Columbus
country: United States
facility: Valeant Site 06
state: Ohio
city: Mount Pleasant
country: United States
facility: Valeant Site 13
state: South Carolina
city: Katy
country: United States
facility: Valeant Site 11
state: Texas
city: San Antonio
country: United States
facility: Valeant Site 10
state: Texas
city: Sugar Land
country: United States
facility: Valeant Site 01
state: Texas
city: Salt Lake City
country: United States
facility: Valeant Site 14
state: Utah
Study officials:
affiliation: Valeant Pharmaceuticals
name: Binu J Alexander, MD
role: STUDY_DIRECTOR
affiliation: Valeant Pharmaceuticals
name: Binu Alexander
role: STUDY_DIRECTOR
References: