Clinical trial NCT02515097: Safety and Efficacy of IDP-122 in the Treatment of Participants With Plaque Psoriasis
Official title: A Phase 3, Multicenter, Double-Blind, Randomized, Vehicle Controlled Clinical Study to Assess the Safety and Efficacy of IDP-122 in the Treatment of Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Plaque Psoriasis
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2015-08-04
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to evaluate the safety and efficacy of a topical lotion when applied once daily to adult participants with moderate to severe plaque psoriasis (defined as an Investigator's Global Assessment \[IGA\] score of 3 or 4).

Detailed description: The objective of the study is to evaluate the safety and efficacy of topical IDP-122 Lotion when applied once daily to adult participants with moderate to severe plaque psoriasis. The intent of the study is specifically to evaluate the safety and efficacy of a once daily application of IDP-122 Lotion in comparison with vehicle.

Eligibility criteria: 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 score of 3 or 4. (The face, scalp, palms, soles, axillae and intertriginous areas are to be excluded in this assessment).

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: Percentage of Participants With Treatment Success at Week 8
timeFrame: Week 8
Secondary outcomes:
measure: Percentage of Participants With Treatment Success at Weeks 2, 4, 6, and 12
timeFrame: Weeks 2, 4, 6, and 12 (4-week follow-up)
Other outcomes:
Locations:
city: Santa Ana
country: United States
facility: Valeant Site 14
state: California
city: Boynton Beach
country: United States
facility: Valeant Site 02
state: Florida
city: Clearwater
country: United States
facility: Valeant Site 10
state: Florida
city: Tampa
country: United States
facility: Valeant Site 1
state: Florida
city: Plainfield
country: United States
facility: Valeant Site 07
state: Indiana
city: Olathe
country: United States
facility: Valeant Site 15
state: Kansas
city: Fridley
country: United States
facility: Valeant Site 08
state: Minnesota
city: Omaha
country: United States
facility: Valeant Site 13
state: Nebraska
city: New York
country: United States
facility: Valeant Site 04
state: New York
city: Stony Brook
country: United States
facility: Valeant Site 12
state: New York
city: High Point
country: United States
facility: Valeant Site 05
state: North Carolina
city: Knoxville
country: United States
facility: Valeant Site 11
state: Tennessee
city: Houston
country: United States
facility: Valeant Site 03
state: Texas
city: San Antonio
country: United States
facility: Valeant Site 09
state: Texas
city: West Jordan
country: United States
facility: Valeant Site 06
state: Utah
Study officials:
affiliation: Valeant Pharmaceuticals
name: Binu J Alexander
role: STUDY_DIRECTOR
References: