Clinical trial NCT02785159: Safety and Efficacy of IDP-118 Lotion in the Treatment of Plaque Psoriasis
Official title: A Phase 2, Multicenter, Double Blinded, Randomized, Vehicle Controlled Study to Compare the Safety and Efficacy of IDP-118 Lotion With Tazorac (Tazarotene) Cream, 0.05% 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: 152
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 in the Treatment of Plaque Psoriasis

Detailed description: A Phase 2, Multicenter, Double-Blinded, Randomized, Vehicle-Controlled Study to Compare the Safety and Efficacy of IDP-118 Lotion with Tazorac (tazarotene) Cream, 0.05% 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 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 (IGA) Investigator 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.)

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, Defined by at Least a 2 Grade Improvement From Baseline in the Investigator Global Assessment (IGA) Score Equating to Clear or Almost Clear.
timeFrame: 12 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Encino
country: United States
facility: Valeant Site 12
state: California
city: Orange Park
country: United States
facility: Valeant Site 13
state: Florida
city: Pinellas Park
country: United States
facility: Valeant Site 11
state: Florida
city: Tampa
country: United States
facility: Valeant Site 01
state: Florida
city: Tampa
country: United States
facility: Valeant Site 04
state: Florida
city: Plainfield
country: United States
facility: Valeant Site 05
state: Indiana
city: Clarkston
country: United States
facility: Valeant Site 09
state: Michigan
city: Fridley
country: United States
facility: Valeant Site 07
state: Minnesota
city: Saint Joseph
country: United States
facility: Valeant Site 14
state: Missouri
city: Greenville
country: United States
facility: Valeant Site 10
state: South Carolina
city: Murfreesboro
country: United States
facility: Valeant Site 03
state: Tennessee
city: College Station
country: United States
facility: Valeant Site 06
state: Texas
city: Webster
country: United States
facility: Valeant Site 08
state: Texas
city: Charlottesville
country: United States
facility: Valeant Site 02
state: Virginia
Study officials:
affiliation: Valeant Pharmaceuticals
name: Binu J Alexander, MD
role: STUDY_DIRECTOR
References: