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

Phase 2

Completed

• Conditions: Plaque Psoriasis
• Interventions: Drug: IDP-118 Monad HP Lotion; Drug: IDP-118 Lotion; Drug: IDP-118 Monad Taz Lotion; Drug: IDP-118 Vehicle Lotion

• Registration Number: NCT02045277
• Lead Sponsor: Bausch Health Americas, Inc.

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2014-01-22
• Study First Submitted QC: 2014-01-22
• Study First Posted: 2014-01-24
• Study Start: 2014-02
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Disposition First Submitted: 2017-12-13
• Disposition First Submitted QC: 2017-12-13
• Disposition First Posted: 2017-12-15
• Status Verified: 2020-08
• Results First Submitted: 2020-08-08
• Results First Submitted QC: 2020-08-08
• Last Update Submitted: 2020-08-08
• Results First Posted: 2020-08-20
• Last Update Posted: 2020-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 212

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
IDP-118 Monad HP Lotion	IDP-118 Monad HP Lotion	HP
IDP-118 Lotion	IDP-118 Lotion	halobetasol propionate \[HP\], tazarotene \[Taz\]
IDP-118 Monad Taz Lotion	IDP-118 Monad Taz Lotion	Taz
IDP-118 Vehicle Lotion	IDP-118 Vehicle Lotion	Vehicle

Primary Outcome Measures

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

Trial Locations

Locations (18)

Valeant Site 13; 🇺🇸 Encino, California, United States

Valeant Site 15; 🇺🇸 Santa Rosa, California, United States

Valeant Site 11; 🇺🇸 San Diego, California, United States

Valeant Site 10; 🇺🇸 Augusta, Georgia, United States

Valeant Site 09; 🇺🇸 Newnan, Georgia, United States

Valeant Site 04; 🇺🇸 Rockville, Maryland, United States

Valeant Site 01; 🇺🇸 East Windsor, New Jersey, United States

Valeant Site 06; 🇺🇸 College Station, Texas, United States

Valeant Site 16; 🇺🇸 Salt Lake City, Utah, United States

Valeant Site 18; 🇺🇸 Lynchburg, Virginia, United States

Valeant Site 12; 🇺🇸 Norfolk, Virginia, United States

Valeant Site 14; 🇺🇸 Clinton Township, Michigan, United States

Valeant Site 07; 🇺🇸 Fridley, Minnesota, United States

Valeant Site 02; 🇺🇸 High Point, North Carolina, United States

Valeant Site 17; 🇺🇸 Rochester, New York, United States

Valeant Site 03; 🇺🇸 New York, New York, United States

Valeant Site 08; 🇺🇸 Louisville, Kentucky, United States

Valeant Site 05; 🇺🇸 Austin, Texas, United States