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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02514577
Other study ID # V01-122A-301
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date November 7, 2015
Est. completion date May 1, 2017

Study information

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

Clinical Trial Summary

This study is to evaluate the safety and efficacy of a topical lotion when applied once daily to adult participants with moderate to severe plaque psoriasis (defined as an Investigator's Global Assessment [IGA] score of 3 or 4).


Description:

This study is a multicenter, double-blind, randomized, parallel-group study designed to assess the safety and efficacy of IDP-122 Lotion in comparison with its vehicle. To be eligible for the study, participants must be at least 18 years of age and have a clinical diagnosis of moderate to severe psoriasis (defined as an IGA score of 3 or 4).


Recruitment information / eligibility

Status Completed
Enrollment 217
Est. completion date May 1, 2017
Est. primary completion date May 1, 2017
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 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
IDP-122 Lotion
Topical lotion
IDP-122 Vehicle Lotion
Topical lotion. No active ingredient.

Locations

Country Name City State
United States Valeant Site 4 Ann Arbor Michigan
United States Valeant Site 13 Atlanta Georgia
United States Valeant Site 3 Austin Texas
United States Valeant Site 7 Boise Idaho
United States Valeant Site 8 Clarkston Michigan
United States Valeant Site 1 Encinitas California
United States Valeant Site 10 Encino California
United States Valeant Site 11 Hot Springs Arkansas
United States Valeant Site 5 Knoxville Tennessee
United States Valeant Site 15 Las Vegas Nevada
United States Valeant Site 9 Raleigh North Carolina
United States Valeant Site 6 Rockville Maryland
United States Valeant Site 2 San Antonio Texas
United States Valeant Site 12 Santa Rosa California
United States Valeant Site 14 Spokane Washington

Sponsors (1)

Lead Sponsor Collaborator
Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Treatment Success 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). The face, scalp, palms, soles, axillae, and intertriginous areas were excluded from this assessment. Week 8
Secondary Percentage of Participants With Treatment Success 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). The face, scalp, palms, soles, axillae, and intertriginous areas were excluded from this assessment. Weeks 2, 4, 6, and 12 (4-week follow-up)
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