Safety and Efficacy of IDP-122 Lotion When Applied Topically to Subjects With Moderate to Severe Plaque Psoriasis

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02785185
• Other study ID #: V01-122A-203
• Status: Completed
• Phase: Phase 2
• Start date: June 2016
• Est. completion date: January 2017

Study information

• Verified date: August 2020
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 2017
• Est. primary completion date: December 2, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• IDP-122 Vehicle Lotion
Vehicle
• IDP-122 Vehicle Cream
Vehicle
• IDP-122 Lotion
Lotion
• Ultravate Cream
Cream

Locations

Country	Name	City	State
United States	Valeant Site 08	Albany	Indiana
United States	Valeant Site 10	Beverly Hills	California
United States	Valeant Site 09	Carlsbad	California
United States	Valeant Site 07	Coral Gables	Florida
United States	Valeant Site 06	Fridley	Minnesota
United States	Valeant Site 02	High Point	North Carolina
United States	Valeant Site 01	Houston	Texas
United States	Valeant Site 13	Los Angeles	California
United States	Valeant Site 04	Louisville	Kentucky
United States	Valeant Site 11	North Miami Beach	Florida
United States	Valeant Site 05	Rogers	Arkansas
United States	Valeant Site 03	Sanford	Florida
United States	Valeant Site 12	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Treatment success defined as at least a 2-grade improvement from Baseline in the Investigator's Global Assessment (IGA) score and an IGA score equating to "clear" or "almost clear" at Week 2. The IGA score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe).	2 weeks