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CompletedNCT02045277Updated Aug 20, 2020Results posted

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

A Phase 2 interventional study of IDP-118 Lotion and IDP-118 Monad HP Lotion in Plaque Psoriasis, sponsored by Bausch Health Americas, Inc.. Completed at 18 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-20.

Sponsored by Bausch Health Americas, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
212
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Plaque Psoriasis

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03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's enrollment of 212 is above the median of 70 across 1,447 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Bausch Health Americas, Inc. is the lead sponsor of 209 studies on the registry; 9 are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 16 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
212 participants (actual)

Study arms

  • Experimental
    IDP-118 Lotion

    halobetasol propionate \[HP\], tazarotene \[Taz\]

    Drug: IDP-118 Lotion

  • Active comparator
    IDP-118 Monad HP Lotion

    HP

    Drug: IDP-118 Monad HP Lotion

  • Active comparator
    IDP-118 Monad Taz Lotion

    Taz

    Drug: IDP-118 Monad Taz Lotion

  • Active comparator
    IDP-118 Vehicle Lotion

    Vehicle

    Drug: IDP-118 Vehicle Lotion

Interventions

  • DrugIDP-118 Lotion

    Lotion

    Also known as: Lotion

  • DrugIDP-118 Monad HP Lotion

    Active Comparator

    Also known as: HP

  • DrugIDP-118 Monad Taz Lotion

    Active Comparator

    Also known as: Taz

  • DrugIDP-118 Vehicle Lotion

    Vehicle

    Also known as: Vehicle

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 8 weeks

  2. 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).

    Time frame: Weeks 2, 4, 6, and 12 (4-week follow-up)

07

Results

Posted Aug 20, 2020

Participant flow

Participant flow — Overall Study
MilestoneIDP-118 LotionIDP-118 Monad HP LotionIDP-118 Monad Taz LotionIDP-118 Vehicle Lotion
Started59635931
Completed55624729
Not completed41122

Outcome measures

PrimaryPercentage 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).

Time frame:
8 weeks
Reported as:
Number · percentage of participants
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
percentage of participantsIDP-118 LotionIDP-118 Monad HP LotionIDP-118 Monad Taz LotionIDP-118 Vehicle Lotion
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 852.533.318.69.7
PrimaryPercentage 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).

Time frame:
Weeks 2, 4, 6, and 12 (4-week follow-up)
Reported as:
Number · percentage of participants
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
percentage of participantsIDP-118 LotionIDP-118 Monad HP LotionIDP-118 Monad Taz LotionIDP-118 Vehicle Lotion
Week 211.94.81.70
Week 425.417.51.76.5
Week 632.225.415.33.2
Week 1238.221.012.86.9

Adverse events

Collected over 12 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
IDP-118 Lotion—0/59 (0%)7/59 (11.9%)
IDP-118 Monad HP Lotion—1/62 (1.6%)0/62 (0%)
IDP-118 Monad Taz Lotion—1/58 (1.7%)9/58 (15.5%)
IDP-118 Vehicle Lotion—2/31 (6.5%)4/31 (12.9%)
Most frequent serious events
Most frequent serious events
EventIDP-118 LotionIDP-118 Monad HP LotionIDP-118 Monad Taz LotionIDP-118 Vehicle Lotion
Cardiac failure congestiveCardiac disorders0/590/620/581/31
Hernia obstructiveGeneral disorders0/590/620/581/31
InfectionInfections and infestations0/590/620/581/31
Colorectal adenocarcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/590/621/580/31
Coronary artery diseaseCardiac disorders0/591/620/580/31
Acute myocardial infarctionCardiac disorders0/591/620/580/31
Most frequent other events
Most frequent other events
EventIDP-118 LotionIDP-118 Monad HP LotionIDP-118 Monad Taz LotionIDP-118 Vehicle Lotion
Application site painGeneral disorders2/590/625/581/31
Application site pruritusGeneral disorders2/590/624/580/31
Pain in extremityMusculoskeletal and connective tissue disorders0/590/620/582/31
Application site erythemaGeneral disorders1/590/623/580/31
HeadacheNervous system disorders3/590/621/581/31

Baseline characteristics

Age, Continuous
Age, Continuous(years)IDP-118 LotionIDP-118 Monad HP LotionIDP-118 Monad Taz LotionIDP-118 Vehicle LotionTotal
Mean48.2 ± 13.7054.2 ± 11.5255.7 ± 13.1052.4 ± 16.1152.66 ± 13.55
Sex: Female, Male
Sex: Female, Male(Participants)IDP-118 LotionIDP-118 Monad HP LotionIDP-118 Monad Taz LotionIDP-118 Vehicle LotionTotal
Female2424191279
Male35394019133
08

Study locations

18 sites
  • Valeant Site 13
    Encino, California 91436, United States
  • Valeant Site 11
    San Diego, California 92123, United States
  • Valeant Site 15
    Santa Rosa, California 95403, United States
  • Valeant Site 10
    Augusta, Georgia 30909, United States
  • Valeant Site 09
    Newnan, Georgia 30263, United States
  • Valeant Site 08
    Louisville, Kentucky 40217, United States
  • Valeant Site 04
    Rockville, Maryland 20850, United States
  • Valeant Site 14
    Clinton Township, Michigan 48038, United States
  • Valeant Site 07
    Fridley, Minnesota 55432, United States
  • Valeant Site 01
    East Windsor, New Jersey 08520, United States
  • Valeant Site 03
    New York, New York 10075, United States
  • Valeant Site 17
    Rochester, New York 14623, United States
  • Valeant Site 02
    High Point, North Carolina 27262, United States
  • Valeant Site 05
    Austin, Texas 78759, United States
  • Valeant Site 06
    College Station, Texas 77845, United States
  • Valeant Site 16
    Salt Lake City, Utah 84117, United States
  • Valeant Site 18
    Lynchburg, Virginia 24501, United States
  • Valeant Site 12
    Norfolk, Virginia 23507, United States
09

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02045277
Lead sponsor
Bausch Health Americas, Inc.
Collaborators
Dow Pharmaceutical Sciences
Responsible party
Sponsor
First posted
Jan 24, 2014
Start date
Feb 2014
Primary completion
Nov 2014
Completion
Nov 2014
Results posted
Aug 20, 2020
Last update
Aug 20, 2020

Study contacts

Binu J Alexander
study director · Valeant Pharmaceuticals

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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