Clinical trial NCT02462083: Long-Term Safety of IDP-118 Lotion in the Treatment of Plaque Psoriasis
Official title: A Phase 3, Multicenter, Open Label Study to Evaluate the Long-Term Safety of IDP-118 Lotion 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: 555
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the long-term safety of IDP-118 lotion.

Detailed description: This is a multicenter, open-label study of the long-term safety of IDP-118 lotion in participants with 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 percent (%), 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 Investigators Global Assessment (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: Percentage of Participants Who Experienced Grade 3 Local Skin Reactions
timeFrame: Baseline up to Week 52
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Valeant Site 6
state: Alabama
city: Beverly Hills
country: United States
facility: Valeant Site 24
state: California
city: Encinitas
country: United States
facility: Valeant Site 32
state: California
city: Encino
country: United States
facility: Valeant Site 27
state: California
city: Los Angeles
country: United States
facility: Valeant Site 33
state: California
city: Los Angeles
country: United States
facility: Valeant Site 43
state: California
city: Sacramento
country: United States
facility: Valeant Site 45
state: California
city: San Diego
country: United States
facility: Valeant Site 25
state: California
city: San Diego
country: United States
facility: Valeant Site 4
state: California
city: Santa Monica
country: United States
facility: Valeant Site 44
state: California
city: Santa Rosa
country: United States
facility: Valeant Site 36
state: California
city: Englewood
country: United States
facility: Valeant Site 10
state: Colorado
city: Boynton Beach
country: United States
facility: Valeant Site 3
state: Florida
city: Coral Gables
country: United States
facility: Valeant Site 28
state: Florida
city: Miami
country: United States
facility: Valeant Site 1
state: Florida
city: North Miami Beach
country: United States
facility: Valeant Site 37
state: Florida
city: Sanford
country: United States
facility: Valeant Site 13
state: Florida
city: Snellville
country: United States
facility: Valeant Site 41
state: Georgia
city: South Bend
country: United States
facility: Valeant Site 17
state: Indiana
city: Olathe
country: United States
facility: Valeant Site 12
state: Kansas
city: Louisville
country: United States
facility: Valeant Site 19
state: Kentucky
city: Louisville
country: United States
facility: Valeant Site 14
state: Kentucky
city: Clinton Township
country: United States
facility: Valeant Site 35
state: Michigan
city: Detroit
country: United States
facility: Valeant Site 34
state: Michigan
city: Warren
country: United States
facility: Valeant Site 16
state: Michigan
city: Fridley
country: United States
facility: Valeant Site 18
state: Minnesota
city: Omaha
country: United States
facility: Valeant Site 31
state: Nebraska
city: East Windsor
country: United States
facility: Valeant Site 2
state: New Jersey
city: New York
country: United States
facility: Valeant Site 29
state: New York
city: Rochester
country: United States
facility: Valeant Site 39
state: New York
city: Portland
country: United States
facility: Valeant Site 5
state: Oregon
city: Philadelphia
country: United States
facility: Valeant Site 11
state: Pennsylvania
city: Charleston
country: United States
facility: Valeant Site 30
state: South Carolina
city: Nashville
country: United States
facility: Valeant Site 15
state: Tennessee
city: Dallas
country: United States
facility: Valeant Site 9
state: Texas
city: Houston
country: United States
facility: Valeant Site 40
state: Texas
city: Houston
country: United States
facility: Valeant Site 8
state: Texas
city: Katy
country: United States
facility: Valeant Site 46
state: Texas
city: Pflugerville
country: United States
facility: Valeant Site 20
state: Texas
city: San Antonio
country: United States
facility: Valeant Site 21
state: Texas
city: San Antonio
country: United States
facility: Valeant Site 7
state: Texas
city: Webster
country: United States
facility: Valeant Site 22
state: Texas
city: Salt Lake City
country: United States
facility: Valeant Site 38
state: Utah
city: Lynchburg
country: United States
facility: Valeant Site 23
state: Virginia
city: Norfolk
country: United States
facility: Valeant Site 26
state: Virginia
city: Spokane
country: United States
facility: Valeant Site 42
state: Washington
Study officials:
affiliation: Valeant Pharmaceuticals
name: Binu J Alexander
role: STUDY_DIRECTOR
References: