Safety and Efficacy of IDP 118 in the Treatment of Plaque Psoriasis

Plaque Psoriasis Clinical Trial

Official title:

A Phase 2, Multicenter, Double-Blind, Randomized, Vehicle Controlled Clinical Study to Assess the Safety and Efficacy of IDP 118 in the Treatment of Plaque Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02045277
• Other study ID #: V01-118A-201
• Status: Completed
• Phase: Phase 2
• Start date: February 2014
• Est. completion date: November 2014

Study information

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

Clinical Trial Summary

The objective of the study is to evaluate the safety and efficacy of a topical lotion

Description:

The objective of the study is to evaluate the safety and efficacy of a topical lotion when applied once daily to adult subjects with moderate to severe plaque psoriasis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• 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 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, 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-118 Lotion
Lotion
• IDP-118 Monad HP Lotion
Active Comparator
• IDP-118 Monad Taz Lotion
Active Comparator
• IDP-118 Vehicle Lotion
Vehicle

Locations

Country	Name	City	State
United States	Valeant Site 10	Augusta	Georgia
United States	Valeant Site 05	Austin	Texas
United States	Valeant Site 14	Clinton Township	Michigan
United States	Valeant Site 06	College Station	Texas
United States	Valeant Site 01	East Windsor	New Jersey
United States	Valeant Site 13	Encino	California
United States	Valeant Site 07	Fridley	Minnesota
United States	Valeant Site 02	High Point	North Carolina
United States	Valeant Site 08	Louisville	Kentucky
United States	Valeant Site 18	Lynchburg	Virginia
United States	Valeant Site 03	New York	New York
United States	Valeant Site 09	Newnan	Georgia
United States	Valeant Site 12	Norfolk	Virginia
United States	Valeant Site 17	Rochester	New York
United States	Valeant Site 04	Rockville	Maryland
United States	Valeant Site 16	Salt Lake City	Utah
United States	Valeant Site 11	San Diego	California
United States	Valeant Site 15	Santa Rosa	California

Sponsors (2)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.	Dow Pharmaceutical Sciences

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 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).	8 weeks
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 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).	Weeks 2, 4, 6, and 12 (4-week follow-up)