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

Phase 1

Completed

• Conditions: Psoriasis
• Interventions: Drug: IDP-118 Lotion; Drug: HP Monad Lotion; Drug: Ultravate Cream; Drug: Tazorac Cream

• Registration Number: NCT03058744
• Lead Sponsor: Bausch Health Americas, Inc.

Brief Summary

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

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 Timeline

• Study Start: 2015-04
• Primary Completion: 2016-12
• Study First Submitted: 2016-12-21
• Study Completion: 2017-01
• Study First Submitted QC: 2017-02-16
• Study First Posted: 2017-02-23
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-08
• Last Update Posted: 2017-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IDP-118 Lotion	IDP-118 Lotion	8 Weeks
HP Monad Lotion	HP Monad Lotion	8 Weeks
Ultravate Cream	Ultravate Cream	2 Weeks
Tazorac Cream	Tazorac Cream	4 Weeks

Primary Outcome Measures

Name	Time	Method
Local Skin Reactions (LSRs)	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.

Trial Locations

Locations (12)

Valeant Site 05; 🇺🇸 Encino, California, United States

Valeant Site 06; 🇺🇸 New York, New York, United States

Valeant Site 01; 🇺🇸 San Diego, California, United States

Valeant Site 07; 🇺🇸 Santa Rosa, California, United States

Valeant Site 09; 🇺🇸 Sanford, Florida, United States

Valeant Site 12; 🇺🇸 Anaheim, California, United States

Valeant Site 08; 🇺🇸 Atlanta, Georgia, United States

Valeant Site 10; 🇺🇸 Orange Park, Florida, United States

Valeant Site 04; 🇺🇸 Plainfield, Indiana, United States

Valeant Site 11; 🇺🇸 Philadelphia, Pennsylvania, United States

Valeant Site 02; 🇺🇸 Katy, Texas, United States

Valeant Site 03; 🇺🇸 Austin, Texas, United States