Clinical trial NCT02045277: Safety and Efficacy of IDP 118 in the Treatment of Plaque Psoriasis
Official title: A Phase 2, Multicenter, Double-Blind, Randomized, Vehicle Controlled Clinical Study to Assess the Safety and Efficacy of IDP 118 in the Treatment of Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Plaque Psoriasis
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Dow Pharmaceutical Sciences
First posted: 2014-01-24
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The objective of the study is to evaluate the safety and efficacy of a topical lotion

Detailed description: The objective of the study is to evaluate the safety and efficacy of a topical lotion when applied once daily to adult subjects with moderate to severe 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 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, 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: Percentage of Participants With Treatment Success of a 2-Grade IGA Score Improvement From Baseline and an IGA Score of Clear or Almost Clear at Week 8
timeFrame: 8 weeks
measure: Percentage of Participants With Treatment Success of a 2-Grade IGA Score Improvement From Baseline and an IGA Score of Clear or Almost Clear at Weeks 2, 4, 6, and 12
timeFrame: Weeks 2, 4, 6, and 12 (4-week follow-up)
Secondary outcomes:
Other outcomes:
Locations:
city: Encino
country: United States
facility: Valeant Site 13
state: California
city: San Diego
country: United States
facility: Valeant Site 11
state: California
city: Santa Rosa
country: United States
facility: Valeant Site 15
state: California
city: Augusta
country: United States
facility: Valeant Site 10
state: Georgia
city: Newnan
country: United States
facility: Valeant Site 09
state: Georgia
city: Louisville
country: United States
facility: Valeant Site 08
state: Kentucky
city: Rockville
country: United States
facility: Valeant Site 04
state: Maryland
city: Clinton Township
country: United States
facility: Valeant Site 14
state: Michigan
city: Fridley
country: United States
facility: Valeant Site 07
state: Minnesota
city: East Windsor
country: United States
facility: Valeant Site 01
state: New Jersey
city: New York
country: United States
facility: Valeant Site 03
state: New York
city: Rochester
country: United States
facility: Valeant Site 17
state: New York
city: High Point
country: United States
facility: Valeant Site 02
state: North Carolina
city: Austin
country: United States
facility: Valeant Site 05
state: Texas
city: College Station
country: United States
facility: Valeant Site 06
state: Texas
city: Salt Lake City
country: United States
facility: Valeant Site 16
state: Utah
city: Lynchburg
country: United States
facility: Valeant Site 18
state: Virginia
city: Norfolk
country: United States
facility: Valeant Site 12
state: Virginia
Study officials:
affiliation: Valeant Pharmaceuticals
name: Binu J Alexander
role: STUDY_DIRECTOR
References: