Safety and Efficacy of IDP-122 in the Treatment of Participants With Plaque Psoriasis
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02514577 |
Recruitment Status :
Completed
First Posted : August 3, 2015
Results First Posted : January 27, 2020
Last Update Posted : January 27, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Plaque Psoriasis | Drug: IDP-122 Lotion Drug: IDP-122 Vehicle Lotion | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 217 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | November 7, 2015 |
Actual Primary Completion Date : | May 1, 2017 |
Actual Study Completion Date : | May 1, 2017 |
Arm | Intervention/treatment |
---|---|
Experimental: IDP-122 Lotion
Participants will apply IDP-122 Lotion (halobetasol propionate [HP] 0.01%) topically once daily for 8 weeks.
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Drug: IDP-122 Lotion
Topical lotion
Other Name: HP 0.01% |
Active Comparator: IDP-122 Vehicle Lotion
Participants will apply IDP-122 Vehicle Lotion topically once daily for 8 weeks.
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Drug: IDP-122 Vehicle Lotion
Topical lotion. No active ingredient. |
- Percentage of Participants With Treatment Success at Week 8 [ Time Frame: 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.
- Percentage of Participants With Treatment Success at Weeks 2, 4, 6, and 12 [ Time Frame: 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). The face, scalp, palms, soles, axillae, and intertriginous areas were excluded from this assessment.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 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 from this calculation, 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02514577
United States, Arkansas | |
Valeant Site 11 | |
Hot Springs, Arkansas, United States, 71901 | |
United States, California | |
Valeant Site 1 | |
Encinitas, California, United States, 92023 | |
Valeant Site 10 | |
Encino, California, United States, 91436 | |
Valeant Site 12 | |
Santa Rosa, California, United States, 95401 | |
United States, Georgia | |
Valeant Site 13 | |
Atlanta, Georgia, United States, 30301 | |
United States, Idaho | |
Valeant Site 7 | |
Boise, Idaho, United States, 83701 | |
United States, Maryland | |
Valeant Site 6 | |
Rockville, Maryland, United States, 20847 | |
United States, Michigan | |
Valeant Site 4 | |
Ann Arbor, Michigan, United States, 48103 | |
Valeant Site 8 | |
Clarkston, Michigan, United States, 48346 | |
United States, Nevada | |
Valeant Site 15 | |
Las Vegas, Nevada, United States, 89101 | |
United States, North Carolina | |
Valeant Site 9 | |
Raleigh, North Carolina, United States, 27601 | |
United States, Tennessee | |
Valeant Site 5 | |
Knoxville, Tennessee, United States, 37901 | |
United States, Texas | |
Valeant Site 3 | |
Austin, Texas, United States, 73301 | |
Valeant Site 2 | |
San Antonio, Texas, United States, 78201 | |
United States, Washington | |
Valeant Site 14 | |
Spokane, Washington, United States, 99201 |
Study Director: | Binu j Alexander | Valeant Pharmaceuticals |
Documents provided by Bausch Health Americas, Inc.:
Responsible Party: | Bausch Health Americas, Inc. |
ClinicalTrials.gov Identifier: | NCT02514577 |
Other Study ID Numbers: |
V01-122A-301 |
First Posted: | August 3, 2015 Key Record Dates |
Results First Posted: | January 27, 2020 |
Last Update Posted: | January 27, 2020 |
Last Verified: | January 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Psoriasis Skin Diseases, Papulosquamous Skin Diseases |