Clinical trial NCT02462122: Safety and Efficacy of IDP-118 in the Treatment of Plaque Psoriasis
Official title: A Phase 3, 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: PHASE3
Conditions: Plaque Psoriasis
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Dow Pharmaceutical Sciences
First posted: 2015-06-03
Enrollment: 215
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: Safety and Efficacy of IDP-118 in the treatment of plaque psoriasis

Detailed description: A Phase 3, Multicenter, Double-Blind, Randomized, Vehicle Controlled Clinical Study to Assess the Safety and Efficacy of IDP-118 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 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).

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: The Percentage of Participants With Treatment Success at Week 8
timeFrame: 8 weeks
Secondary outcomes:
measure: Percentage of Participants With Treatment Success at Weeks 12, 6, 4, and 2
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Fremont
country: United States
facility: Valeant Site 5
state: California
city: Boynton Beach
country: United States
facility: Valeant Site 2
state: Florida
city: North Miami Beach
country: United States
facility: Valeant Site 14
state: Florida
city: Detroit
country: United States
facility: Valeant Site 13
state: Michigan
city: Warren
country: United States
facility: Valeant Site 8
state: Michigan
city: Fridley
country: United States
facility: Valeant Site 10
state: Minnesota
city: East Windsor
country: United States
facility: Valeant Site 1
state: New Jersey
city: Albuquerque
country: United States
facility: Valeant Site 4
state: New Mexico
city: New York
country: United States
facility: Valeant Site 12
state: New York
city: High Point
country: United States
facility: Valeant Site 6
state: North Carolina
city: Portland
country: United States
facility: Valeant Site 3
state: Oregon
city: Knoxville
country: United States
facility: Valeant Site 7
state: Tennessee
city: College Station
country: United States
facility: Valeant Site 9
state: Texas
city: Houston
country: United States
facility: Valeant Site 15
state: Texas
city: Houston
country: United States
facility: Valeant Site 16
state: Texas
city: Pflugerville
country: United States
facility: Valeant Site 11
state: Texas
Study officials:
affiliation: Valeant Pharmaceuticals
name: Binu J Alexander, MD
role: STUDY_DIRECTOR
References: