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

Information source: Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Plaque Psoriasis

Intervention: IDP-118 Lotion (Drug); IDP-118 Monad HP 0.01% Lotion (Drug); IDP-118 Monad Taz 0.045% Lotion (Drug); IDP-118 Vehicle Lotion (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Valeant Pharmaceuticals International, Inc.


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.

Clinical Details

Official title: A Phase 2, Multicenter, Double-Blind, Randomized, Vehicle Controlled Clinical Study to Assess the Safety and Efficacy of IDP 118 in the Treatment of Plaque Psoriasis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

The percent of subjects who experience a local skin reaction graded at a level of 3 at any point in the study

The percent of subjects with at least a 2-grade improvement from Baseline in the score for each of the signs of psoriasis


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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.

Locations and Contacts

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 Twp, Michigan 48038, United States

Valeant Site 07, Fridley, Minnesota 55432, United States

Valeant Site 01, East Windsor, New Jersey, 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

Additional Information

Starting date: February 2014
Last updated: December 8, 2014

Page last updated: August 23, 2015

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