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CompletedNCT02785185Updated Aug 27, 2020Results posted

Safety and Efficacy of IDP-122 Lotion When Applied Topically to Subjects With Moderate to Severe Plaque Psoriasis

A Phase 2 interventional study of IDP-122 Vehicle Lotion and IDP-122 Vehicle Cream in Psoriasis, sponsored by Bausch Health Americas, Inc.. Completed at 13 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-27.

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

Phase
Phase 2
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study.

Read the detailed description

A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study to Compare the Safety and Efficacy of IDP-122 Lotion (0.01% halobetasol propionate) to Ultravate® (halobetasol propionate) Cream, 0.05% in the Treatment of Plaque Psoriasis.

02

Conditions studied

  • 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 150 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
Yes

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.
  • Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study.
  • Subject is willing to comply with study instructions and return to the clinic for required visits.

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.
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Study design

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

Study arms

  • Experimental
    IDP-122 Lotion

    Lotion

    Drug: IDP-122 Lotion

  • Active comparator
    Ultravate Cream

    Cream

    Drug: Ultravate Cream

  • Active comparator
    IDP-122 Vehicle Lotion

    Lotion

    Drug: IDP-122 Vehicle Lotion

  • Active comparator
    IDP-122 Vehicle Cream

    Cream

    Drug: IDP-122 Vehicle Cream

Interventions

  • DrugIDP-122 Vehicle Lotion

    Vehicle

    Also known as: Lotion

  • DrugIDP-122 Vehicle Cream

    Vehicle

    Also known as: Cream

  • DrugIDP-122 Lotion

    Lotion

    Also known as: Lotion

  • DrugUltravate Cream

    Cream

    Also known as: Ultravate

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 2

    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 Week 2. 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: 2 weeks

07

Results

Posted Aug 27, 2020

Participant flow

Participant flow — Overall Study
MilestoneIDP-122 LotionUltravate CreamIDP-122 Vehicle LotionIDP-122 Vehicle Cream
Started60571716
Completed59561516
Not completed1120

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 2

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 Week 2. 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:
2 weeks
Reported as:
Count of participants · 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 2
ParticipantsIDP-122 LotionUltravate CreamIDP-122 Vehicle LotionIDP-122 Vehicle Cream
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 2181831

Adverse events

Collected over 8 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
IDP-122 Lotion—0/60 (0%)0/60 (0%)
Ultravate Cream—0/57 (0%)0/57 (0%)
IDP-122 Vehicle Lotion—0/15 (0%)1/15 (6.7%)
IDP-122 Vehicle Cream—0/16 (0%)0/16 (0%)
Most frequent other events
Most frequent other events
EventIDP-122 LotionUltravate CreamIDP-122 Vehicle LotionIDP-122 Vehicle Cream
Application site warmthGeneral disorders0/600/571/150/16

Baseline characteristics

Age, Continuous
Age, Continuous(years)IDP-122 LotionUltravate CreamIDP-122 Vehicle LotionIDP-122 Vehicle CreamTotal
Mean50.8 ± 14.250.2 ± 10.9144.7 ± 8.848.6 ± 14.9849.6 ± 12.6
Sex: Female, Male
Sex: Female, Male(Participants)IDP-122 LotionUltravate CreamIDP-122 Vehicle LotionIDP-122 Vehicle CreamTotal
Female252761270
Male353011480
08

Study locations

13 sites
  • Valeant Site 05
    Rogers, Arkansas 75758, United States
  • Valeant Site 10
    Beverly Hills, California 90210, United States
  • Valeant Site 09
    Carlsbad, California 92008, United States
  • Valeant Site 13
    Los Angeles, California 90045, United States
  • Valeant Site 12
    Santa Monica, California 90404, United States
  • Valeant Site 07
    Coral Gables, Florida 33134, United States
  • Valeant Site 11
    North Miami Beach, Florida 33162, United States
  • Valeant Site 03
    Sanford, Florida 32771, United States
  • Valeant Site 08
    Albany, Indiana 47150, United States
  • Valeant Site 04
    Louisville, Kentucky 40202, United States
  • Valeant Site 06
    Fridley, Minnesota 55432, United States
  • Valeant Site 02
    High Point, North Carolina 27262, United States
  • Valeant Site 01
    Houston, Texas 77065, United States
09

References and documents

Publications

  • Kerdel FA, Draelos ZD, Tyring SK, Lin T, Pillai R. A phase 2, multicenter, double-blind, randomized, vehicle-controlled clinical study to compare the safety and efficacy of a halobetasol propionate 0.01% lotion and halobetasol propionate 0.05% cream in the treatment of plaque psoriasis. J Dermatolog Treat. 2019 Jun;30(4):333-339. doi: 10.1080/09546634.2018.1523362. Epub 2018 Nov 5. PubMed 30207807 ↗

Individual participant data

Plan to share: Yes

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02785185
Lead sponsor
Bausch Health Americas, Inc.
Responsible party
Sponsor
First posted
May 27, 2016
Start date
Jun 2016
Primary completion
Dec 2, 2016
Completion
Jan 2017
Results posted
Aug 27, 2020
Last update
Aug 27, 2020

Study contacts

Binu J Alexander, MD
study director · Valeant Pharmaceuticals

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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