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

Last updated: August 8, 2020
Sponsor: Bausch Health Americas, Inc.
Overall Status: Completed

Phase

3

Condition

Rosacea

Warts

Psoriasis And Psoriatic Disorders

Treatment

N/A

Clinical Study ID

NCT02462070
V01-118A-301
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 ofat least 3%, but no more than 12%. The face, scalp, palms, soles, axillae andintertriginous areas are to be excluded in this calculation.

  • Is willing and able to avoid prolonged exposure of the treatment area to ultravioletradiation (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

  1. (The face, scalp, palms, soles, axillae and intertriginous areas are to be excludedin this assessment).

Exclusion

Key Exclusion Criteria:

  • Has spontaneously improving or rapidly deteriorating plaque psoriasis or pustularpsoriasis, as determined by the investigator.

  • Presents with psoriasis that was treated with prescription medication and failed torespond to treatment, even partially or temporarily, as determined by theinvestigator.

  • Presents with any concurrent skin condition that could interfere with the evaluationof 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 5drug half lives (whichever is longer) prior to the Baseline visit, or is concurrentlyparticipating in another clinical study with an investigational drug or device.

Study Design

Total Participants: 203
Study Start date:
August 11, 2015
Estimated Completion Date:
December 01, 2016

Study 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.

Connect with a study center

  • Valeant Site 3

    Mobile, Alabama 36601
    United States

    Site Not Available

  • Valeant Site 9

    Beverly Hills, California 90210
    United States

    Site Not Available

  • Valeant Site 12

    Encino, California 91316
    United States

    Site Not Available

  • Valeant Site 10

    San Diego, California 92093
    United States

    Site Not Available

  • Valeant Site 1

    Santa Rosa, California 95403
    United States

    Site Not Available

  • Valeant Site 16

    Denver, Colorado 80123
    United States

    Site Not Available

  • Valeant Site 2

    Tampa, Florida 33601
    United States

    Site Not Available

  • Valeant Site 7

    South Bend, Indiana 46601
    United States

    Site Not Available

  • Valeant Site 8

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Valeant Site 13

    Clinton, Michigan 48036
    United States

    Site Not Available

  • Valeant Site 13

    Clinton Township, Michigan 48036
    United States

    Site Not Available

  • Valeant Site 14

    Rochester, New York 14603
    United States

    Site Not Available

  • Valeant Site 6

    Nashville, Tennessee 37115
    United States

    Site Not Available

  • Valeant Site 5

    Austin, Texas 73344
    United States

    Site Not Available

  • Valeant Site 4

    Houston, Texas 77001
    United States

    Site Not Available

  • Valeant Site 11

    Norfolk, Virginia 23501
    United States

    Site Not Available

  • Valeant Site 15

    Spokane, Washington 99201
    United States

    Site Not Available

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