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Topically Applied IDP-118 Lotion and HP Monad Lotion in Subjects With Moderate to Severe Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT03058744
Recruitment Status : Completed
First Posted : February 23, 2017
Last Update Posted : June 9, 2017
Sponsor:
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc.

Brief Summary:
Suppression Potential of Topically Applied IDP-118 Lotion and HP Monad Lotion in Subjects with Moderate to Severe Plaque Psoriasis.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: IDP-118 Lotion Drug: HP Monad Lotion Drug: Ultravate Cream Drug: Tazorac Cream Phase 1

Detailed Description:
A Phase 1b Open-Label, Randomized Study Evaluating the Absorption and Systemic Pharmacokinetics and HPA Axis Suppression Potential of Topically Applied IDP-118 Lotion and HP Monad Lotion in Subjects with Moderate to Severe Plaque Psoriasis.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b Open Label, Randomized Study Evaluating the Absorption and Systemic Pharmacokinetics and HPA Axis Suppression Potential of Topically Applied IDP-118 Lotion and HP Monad Lotion in Subjects With Moderate to Severe Plaque Psoriasis
Actual Study Start Date : April 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: IDP-118 Lotion
8 Weeks
Drug: IDP-118 Lotion
Lotion
Other Name: Lotion
Experimental: HP Monad Lotion
8 Weeks
Drug: HP Monad Lotion
Lotion
Other Name: Lotion
Active Comparator: Ultravate Cream
2 Weeks
Drug: Ultravate Cream
Cream
Other Name: Ultravate
Active Comparator: Tazorac Cream
4 Weeks
Drug: Tazorac Cream
Cream
Other Name: Taz



Primary Outcome Measures :
  1. Local Skin Reactions (LSRs) [ Time Frame: 8 Weeks ]
    Tolerability will be evaluated through assessment of local signs and symptoms (itching, dryness, burning/stinging) on a scale of non, mild, moderate, and severe.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or Female of any race, at least 18 years old of age (inclusive)
  • Freely provides both written and oral informed consent.
  • Has a clinical diagnosis of psoriasis at the Baseline visit with an Investigator's Global Assessment Score of 3 or 4. The face, scalp ,axillae, and intertriginous areas are to be excluded in this calculation.
  • Has an area of plaque psoriasis for topical treatment that involves a BSA of at least 20%.
  • The willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study.

Key Exclusion Criteria:

  • Has spontaneously improving or rapidly deteriorating plaque psoriasis or postural psoriasis, as determined by the investigator.
  • Presents with psoriasis that was treated with prescription medication and failed to respond to presents).
  • Has a history of adrenal disease.
  • Presents with any other concurrent skin conditions that could interfere with the evaluation of the treatment areas, as determined by the investigator.
  • Is pregnant, nursing, or planning pregnancy during the study period.

Information from the National Library of Medicine

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): NCT03058744


Locations
United States, California
Valeant Site 12
Anaheim, California, United States, 92801
Valeant Site 05
Encino, California, United States, 91436
Valeant Site 01
San Diego, California, United States, 92093
Valeant Site 07
Santa Rosa, California, United States, 95401
United States, Florida
Valeant Site 10
Orange Park, Florida, United States, 32065
Valeant Site 09
Sanford, Florida, United States, 32771
United States, Georgia
Valeant Site 08
Atlanta, Georgia, United States, 30301
United States, Indiana
Valeant Site 04
Plainfield, Indiana, United States, 46168
United States, New York
Valeant Site 06
New York, New York, United States, 10001
United States, Pennsylvania
Valeant Site 11
Philadelphia, Pennsylvania, United States, 19019
United States, Texas
Valeant Site 03
Austin, Texas, United States, 73301
Valeant Site 02
Katy, Texas, United States, 77449
Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
Investigators
Study Director: Lindsey Mathew Valeant Pharmaceuticals

Responsible Party: Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier: NCT03058744     History of Changes
Other Study ID Numbers: V01-118A-501
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: June 9, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Tazarotene
Halobetasol
Clobetasol
Dermatologic Agents
Keratolytic Agents
Vasoconstrictor Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs