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

Psoriasis Clinical Trial

Official title:

A Phase 2, Multicenter, Double Blinded, Randomized, Vehicle Controlled Study to Compare the Safety and Efficacy of IDP-118 Lotion With Tazorac (Tazarotene) Cream, 0.05% in the Treatment of Plaque Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02785159
• Other study ID #: V01-118A-202
• Status: Completed
• Phase: Phase 2
• Start date: February 2016
• Est. completion date: December 2016

Study information

• Verified date: August 2020
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

A Phase 2, Multicenter, Double-Blinded, Randomized, Vehicle-Controlled Study to Compare the Safety and Efficacy of IDP-118 Lotion with Tazorac (tazarotene) Cream, 0.05% in the Treatment of Plaque Psoriasis

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: December 2016
• Est. primary completion date: November 20, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 Body Surface Area (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) Investigator Global Assessment 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.

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• IDP-118 Lotion
Lotion
• Tazorac Cream
Cream
• IDP-118 Vehicle Lotion
Lotion
• IDP-118 Vehicle Cream
Cream

Locations

Country	Name	City	State
United States	Valeant Site 02	Charlottesville	Virginia
United States	Valeant Site 09	Clarkston	Michigan
United States	Valeant Site 06	College Station	Texas
United States	Valeant Site 12	Encino	California
United States	Valeant Site 07	Fridley	Minnesota
United States	Valeant Site 10	Greenville	South Carolina
United States	Valeant Site 03	Murfreesboro	Tennessee
United States	Valeant Site 13	Orange Park	Florida
United States	Valeant Site 11	Pinellas Park	Florida
United States	Valeant Site 05	Plainfield	Indiana
United States	Valeant Site 14	Saint Joseph	Missouri
United States	Valeant Site 01	Tampa	Florida
United States	Valeant Site 04	Tampa	Florida
United States	Valeant Site 08	Webster	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of Subjects With Treatment Success, Defined by at Least a 2 Grade Improvement From Baseline in the Investigator Global Assessment (IGA) Score Equating to Clear or Almost Clear.	Treatment success defined as at least a 2-grade improvement from Baseline in the Investigator's Global Assessment (IGA) score and an IGA score equating to "clear" or "almost clear". The IGA score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe).	12 Weeks