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: NCT02515097
• Other study ID #: V01-122A-302
• Status: Completed
• Phase: Phase 3
• Start date: November 5, 2015
• Est. completion date: March 15, 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:

The objective of the study is to evaluate the safety and efficacy of topical IDP-122 Lotion when applied once daily to adult participants with moderate to severe plaque psoriasis. The intent of the study is specifically to evaluate the safety and efficacy of a once daily application of IDP-122 Lotion in comparison with vehicle.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: March 15, 2017
• Est. primary completion date: March 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 in this assessment).

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
Medicated topical lotion
• IDP-122 Vehicle Lotion
Vehicle topical lotion with no active ingredient

Locations

Country	Name	City	State
United States	Valeant Site 02	Boynton Beach	Florida
United States	Valeant Site 10	Clearwater	Florida
United States	Valeant Site 08	Fridley	Minnesota
United States	Valeant Site 05	High Point	North Carolina
United States	Valeant Site 03	Houston	Texas
United States	Valeant Site 11	Knoxville	Tennessee
United States	Valeant Site 04	New York	New York
United States	Valeant Site 15	Olathe	Kansas
United States	Valeant Site 13	Omaha	Nebraska
United States	Valeant Site 07	Plainfield	Indiana
United States	Valeant Site 09	San Antonio	Texas
United States	Valeant Site 14	Santa Ana	California
United States	Valeant Site 12	Stony Brook	New York
United States	Valeant Site 1	Tampa	Florida
United States	Valeant Site 06	West Jordan	Utah

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)