Clinical trial NCT02785185: Safety and Efficacy of IDP-122 Lotion When Applied Topically to Subjects With Moderate to Severe Plaque Psoriasis
Official title: A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study to Compare the Safety and Efficacy of IDP-122 Lotion (0.01% Halobetasol Propionate) to Ultravate® (Halobetasol Propionate) Cream, 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: 150
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: A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study.

Detailed description: A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study to Compare the Safety and Efficacy of IDP-122 Lotion (0.01% halobetasol propionate) to Ultravate® (halobetasol propionate) 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.
* Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study.
* Subject is willing to comply with study instructions and return to the clinic for required visits.

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 2
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rogers
country: United States
facility: Valeant Site 05
state: Arkansas
city: Beverly Hills
country: United States
facility: Valeant Site 10
state: California
city: Carlsbad
country: United States
facility: Valeant Site 09
state: California
city: Los Angeles
country: United States
facility: Valeant Site 13
state: California
city: Santa Monica
country: United States
facility: Valeant Site 12
state: California
city: Coral Gables
country: United States
facility: Valeant Site 07
state: Florida
city: North Miami Beach
country: United States
facility: Valeant Site 11
state: Florida
city: Sanford
country: United States
facility: Valeant Site 03
state: Florida
city: Albany
country: United States
facility: Valeant Site 08
state: Indiana
city: Louisville
country: United States
facility: Valeant Site 04
state: Kentucky
city: Fridley
country: United States
facility: Valeant Site 06
state: Minnesota
city: High Point
country: United States
facility: Valeant Site 02
state: North Carolina
city: Houston
country: United States
facility: Valeant Site 01
state: Texas
Study officials:
affiliation: Valeant Pharmaceuticals
name: Binu J Alexander, MD
role: STUDY_DIRECTOR
References:
citation: Kerdel FA, Draelos ZD, Tyring SK, Lin T, Pillai R. A phase 2, multicenter, double-blind, randomized, vehicle-controlled clinical study to compare the safety and efficacy of a halobetasol propionate 0.01% lotion and halobetasol propionate 0.05% cream in the treatment of plaque psoriasis. J Dermatolog Treat. 2019 Jun;30(4):333-339. doi: 10.1080/09546634.2018.1523362. Epub 2018 Nov 5.