Safety and Efficacy of IDP-122 in the Treatment of Participants With Plaque Psoriasis

Plaque Psoriasis Clinical Trial

Official title:

A Phase 3, Multicenter, Double-Blind, Randomized, Vehicle Controlled Clinical Study to Assess the Safety and Efficacy of IDP-122 in the Treatment of Plaque Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02514577
• Other study ID #: V01-122A-301
• Status: Completed
• Phase: Phase 3
• Start date: November 7, 2015
• Est. completion date: May 1, 2017

Study information

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

Clinical Trial Summary

This study is to evaluate the safety and efficacy of a topical lotion when applied once daily to adult participants with moderate to severe plaque psoriasis (defined as an Investigator's Global Assessment [IGA] score of 3 or 4).

Description:

This study is a multicenter, double-blind, randomized, parallel-group study designed to assess the safety and efficacy of IDP-122 Lotion in comparison with its vehicle. To be eligible for the study, participants must be at least 18 years of age and have a clinical diagnosis of moderate to severe psoriasis (defined as an IGA score of 3 or 4).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: May 1, 2017
• Est. primary completion date: May 1, 2017
• Accepts healthy volunteers: No
• 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.

• Has an area of plaque psoriasis appropriate for topical treatment that covers a body surface area (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 from this calculation, 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.

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• IDP-122 Lotion
Topical lotion
• IDP-122 Vehicle Lotion
Topical lotion. No active ingredient.

Locations

Country	Name	City	State
United States	Valeant Site 4	Ann Arbor	Michigan
United States	Valeant Site 13	Atlanta	Georgia
United States	Valeant Site 3	Austin	Texas
United States	Valeant Site 7	Boise	Idaho
United States	Valeant Site 8	Clarkston	Michigan
United States	Valeant Site 1	Encinitas	California
United States	Valeant Site 10	Encino	California
United States	Valeant Site 11	Hot Springs	Arkansas
United States	Valeant Site 5	Knoxville	Tennessee
United States	Valeant Site 15	Las Vegas	Nevada
United States	Valeant Site 9	Raleigh	North Carolina
United States	Valeant Site 6	Rockville	Maryland
United States	Valeant Site 2	San Antonio	Texas
United States	Valeant Site 12	Santa Rosa	California
United States	Valeant Site 14	Spokane	Washington

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 at Week 8	Treatment success defined as at least a 2-grade improvement from Baseline in the IGA score and an IGA score equating to "clear" or "almost clear" at Week 8. 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). The face, scalp, palms, soles, axillae, and intertriginous areas were excluded from this assessment.	Week 8
Secondary	Percentage of Participants With Treatment Success at Weeks 2, 4, 6, and 12	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 Weeks 2, 4, 6, and 12. 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). The face, scalp, palms, soles, axillae, and intertriginous areas were excluded from this assessment.	Weeks 2, 4, 6, and 12 (4-week follow-up)