Long-Term Safety of IDP-118 Lotion in the Treatment of Plaque Psoriasis

Plaque Psoriasis Clinical Trial

Official title:

A Phase 3, Multicenter, Open Label Study to Evaluate the Long-Term Safety of IDP-118 Lotion in the Treatment of Plaque Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02462083
• Other study ID #: V01-118A-303
• Status: Completed
• Phase: Phase 3
• Start date: August 11, 2015
• Est. completion date: April 24, 2017

Study information

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

Clinical Trial Summary

The objective of this study is to evaluate the long-term safety of IDP-118 lotion.

Description:

This is a multicenter, open-label study of the long-term safety of IDP-118 lotion in participants with plaque psoriasis.

Other known NCT identifiers

• NCT02611349

Recruitment information / eligibility

• Status: Completed
• Enrollment: 555
• Est. completion date: April 24, 2017
• Est. primary completion date: January 31, 2017
• 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 Body Surface Area (BSA) of at least 3 percent (%), 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 Investigators Global Assessment (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
IDP-118 lotion will be applied as per the instructions provided by the investigational center staff.

Locations

Country	Name	City	State
United States	Valeant Site 24	Beverly Hills	California
United States	Valeant Site 3	Boynton Beach	Florida
United States	Valeant Site 30	Charleston	South Carolina
United States	Valeant Site 35	Clinton Township	Michigan
United States	Valeant Site 28	Coral Gables	Florida
United States	Valeant Site 9	Dallas	Texas
United States	Valeant Site 34	Detroit	Michigan
United States	Valeant Site 2	East Windsor	New Jersey
United States	Valeant Site 32	Encinitas	California
United States	Valeant Site 27	Encino	California
United States	Valeant Site 10	Englewood	Colorado
United States	Valeant Site 18	Fridley	Minnesota
United States	Valeant Site 40	Houston	Texas
United States	Valeant Site 8	Houston	Texas
United States	Valeant Site 46	Katy	Texas
United States	Valeant Site 33	Los Angeles	California
United States	Valeant Site 43	Los Angeles	California
United States	Valeant Site 14	Louisville	Kentucky
United States	Valeant Site 19	Louisville	Kentucky
United States	Valeant Site 23	Lynchburg	Virginia
United States	Valeant Site 1	Miami	Florida
United States	Valeant Site 6	Mobile	Alabama
United States	Valeant Site 15	Nashville	Tennessee
United States	Valeant Site 29	New York	New York
United States	Valeant Site 26	Norfolk	Virginia
United States	Valeant Site 37	North Miami Beach	Florida
United States	Valeant Site 12	Olathe	Kansas
United States	Valeant Site 31	Omaha	Nebraska
United States	Valeant Site 20	Pflugerville	Texas
United States	Valeant Site 11	Philadelphia	Pennsylvania
United States	Valeant Site 5	Portland	Oregon
United States	Valeant Site 39	Rochester	New York
United States	Valeant Site 45	Sacramento	California
United States	Valeant Site 38	Salt Lake City	Utah
United States	Valeant Site 21	San Antonio	Texas
United States	Valeant Site 7	San Antonio	Texas
United States	Valeant Site 25	San Diego	California
United States	Valeant Site 4	San Diego	California
United States	Valeant Site 13	Sanford	Florida
United States	Valeant Site 44	Santa Monica	California
United States	Valeant Site 36	Santa Rosa	California
United States	Valeant Site 41	Snellville	Georgia
United States	Valeant Site 17	South Bend	Indiana
United States	Valeant Site 42	Spokane	Washington
United States	Valeant Site 16	Warren	Michigan
United States	Valeant Site 22	Webster	Texas

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	Percentage of Participants Who Experienced Grade 3 Local Skin Reactions	Local skin reactions (itching, dryness, burning/stinging) graded at a level of 3 (severe) at any point in the study following the first application of study drug were assessed. Severe Itching (as reported by the participant within the last 24 hours) referred to the intense itching that may interrupt daily activities and/or sleep. Severe dryness (as assessed by the investigator) referred to as marked roughness of the skin. Severe burning/stinging (as reported by the participant within the last 24 hours) referred to as hot burning sensation that causes definite discomfort and may interrupt daily activities and/or sleep. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.	Baseline up to Week 52