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

Plaque Psoriasis Clinical Trial

Official title:

A Phase 3, Multicenter, Double-Blind, Randomized, Vehicle Controlled Clinical Study to Assess the Safety and Efficacy of IDP-118 in the Treatment of Plaque Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02462070
• Other study ID #: V01-118A-301
• Status: Completed
• Phase: Phase 3
• Start date: August 11, 2015
• Est. completion date: December 1, 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

The objective of the study is to evaluate the safety and efficacy of a topical lotion.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: December 1, 2016
• Est. primary completion date: November 8, 2016
• Accepts healthy volunteers: No
• 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 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).

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

• Plaque Psoriasis
• Psoriasis

Intervention

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

Locations

Country	Name	City	State
United States	Valeant Site 5	Austin	Texas
United States	Valeant Site 9	Beverly Hills	California
United States	Valeant Site 13	Clinton Township	Michigan
United States	Valeant Site 16	Denver	Colorado
United States	Valeant Site 12	Encino	California
United States	Valeant Site 4	Houston	Texas
United States	Valeant Site 8	Louisville	Kentucky
United States	Valeant Site 3	Mobile	Alabama
United States	Valeant Site 6	Nashville	Tennessee
United States	Valeant Site 11	Norfolk	Virginia
United States	Valeant Site 14	Rochester	New York
United States	Valeant Site 10	San Diego	California
United States	Valeant Site 1	Santa Rosa	California
United States	Valeant Site 7	South Bend	Indiana
United States	Valeant Site 15	Spokane	Washington
United States	Valeant Site 2	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.	Dow Pharmaceutical Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Percentage of Participants With Treatment Success at Week 8	Treatment success was defined as at least a 2-grade improvement from Baseline in IGA score and an IGA score equating to "Clear" or "Almost Clear". IGA was based on a 5-point scale ranging from 0 to 4; where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.	8 weeks
Secondary	Percentage of Participants With Treatment Success at Weeks 12, 6, 4, and 2	Treatment success was defined as at least a 2-grade improvement from Baseline in IGA score and an IGA score equating to "Clear" or "Almost Clear". IGA was based on a 5-point scale ranging from 0 to 4; where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.	12 weeks