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

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

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

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Ultravate Cream; Drug: IDP-118 Lotion; Drug: Tazorac Cream; Drug: HP Monad Lotion

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
• Enrollment (Actual): 94
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Valeant Site 12
    • Encino, California, United States, 91436
      • Valeant Site 05
    • San Diego, California, United States, 92093
      • Valeant Site 01
    • Santa Rosa, California, United States, 95401
      • Valeant Site 07
  • Florida
    • Orange Park, Florida, United States, 32065
      • Valeant Site 10
    • Sanford, Florida, United States, 32771
      • Valeant Site 09
  • Georgia
    • Atlanta, Georgia, United States, 30301
      • Valeant Site 08
  • Indiana
    • Plainfield, Indiana, United States, 46168
      • Valeant Site 04
  • New York
    • New York, New York, United States, 10001
      • Valeant Site 06
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19019
      • Valeant Site 11
  • Texas
    • Austin, Texas, United States, 73301
      • Valeant Site 03
    • Katy, Texas, United States, 77449
      • Valeant Site 02

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: IDP-118 Lotion; 8 Weeks	Drug: IDP-118 Lotion; Lotion; Other Names: Lotion
EXPERIMENTAL: HP Monad Lotion; 8 Weeks	Drug: HP Monad Lotion; Lotion; Other Names: Lotion
ACTIVE_COMPARATOR: Ultravate Cream; 2 Weeks	Drug: Ultravate Cream; Cream; Other Names: Ultravate
ACTIVE_COMPARATOR: Tazorac Cream; 4 Weeks	Drug: Tazorac Cream; Cream; Other Names: Taz

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bausch Health Americas, Inc.
• Investigators: Study Director: Lindsey Mathew, Valeant Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2015
• Primary Completion (ACTUAL): December 1, 2016
• Study Completion (ACTUAL): January 1, 2017

Study Registration Dates

• First Submitted: December 21, 2016
• First Submitted That Met QC Criteria: February 16, 2017
• First Posted (ACTUAL): February 23, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 9, 2017
• Last Update Submitted That Met QC Criteria: June 8, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dermatologic Agents; Keratolytic Agents; Vasoconstrictor Agents; Clobetasol; Halobetasol; Tazarotene
• Other Study ID Numbers: V01-118A-501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES