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

NCT02462083 | Completed Phase 3 Results

• 1 other identifier: V01-118A-303
• Study Type: interventional
• Target: 555
• Locations: 1 country
• Sites: 46

Brief Summary

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

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

IDP-118 Lotion

EXPERIMENTAL

IDP-118 lotion (halobetasol propionate 0.01%, tazarotene 0.045%) will be applied topically on the affected area once daily for 8 weeks and then as needed once daily for up to 1 year.

Drug: IDP-118 Lotion

Interventions

IDP-118 Lotion DRUG

IDP-118 lotion will be applied as per the instructions provided by the investigational center staff.

IDP-118 Lotion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead
• Dow Pharmaceutical Sciences: collaborator

Study Sites (46)

Valeant Site 6

Mobile, Alabama, 36603, United States

Location

Valeant Site 24

Beverly Hills, California, 90210, United States

Location

Valeant Site 32

Encinitas, California, 92023, United States

Location

Valeant Site 27

Encino, California, 91436, United States

Location

Valeant Site 33

Los Angeles, California, 90001, United States

Location

Valeant Site 43

Los Angeles, California, 90002, United States

Location

Valeant Site 45

Sacramento, California, 94203, United States

Location

Valeant Site 25

San Diego, California, 92093, United States

Location

Valeant Site 4

San Diego, California, 92093, United States

Location

Valeant Site 44

Santa Monica, California, 90401, United States

Location

Valeant Site 36

Santa Rosa, California, 95401, United States

Location

Valeant Site 10

Englewood, Colorado, 80113, United States

Location

Valeant Site 3

Boynton Beach, Florida, 33424, United States

Location

Valeant Site 28

Coral Gables, Florida, 33134, United States

Location

Valeant Site 1

Miami, Florida, 33101, United States

Location

Valeant Site 37

North Miami Beach, Florida, 33160, United States

Location

Valeant Site 13

Sanford, Florida, 32771, United States

Location

Valeant Site 41

Snellville, Georgia, 30039, United States

Location

Valeant Site 17

South Bend, Indiana, 46601, United States

Location

Valeant Site 12

Olathe, Kansas, 66051, United States

Location

Valeant Site 19

Louisville, Kentucky, 40201, United States

Location

Valeant Site 14

Louisville, Kentucky, 40205, United States

Location

Valeant Site 35

Clinton Township, Michigan, 48036, United States

Location

Valeant Site 34

Detroit, Michigan, 48201, United States

Location

Valeant Site 16

Warren, Michigan, 48088, United States

Location

Valeant Site 18

Fridley, Minnesota, 55421, United States

Location

Valeant Site 31

Omaha, Nebraska, 68022, United States

Location

Valeant Site 2

East Windsor, New Jersey, 08520, United States

Location

Valeant Site 29

New York, New York, 10001, United States

Location

Valeant Site 39

Rochester, New York, 14603, United States

Location

Valeant Site 5

Portland, Oregon, 97201, United States

Location

Valeant Site 11

Philadelphia, Pennsylvania, 19019, United States

Location

Valeant Site 30

Charleston, South Carolina, 29401, United States

Location

Valeant Site 15

Nashville, Tennessee, 37115, United States

Location

Valeant Site 9

Dallas, Texas, 75201, United States

Location

Valeant Site 40

Houston, Texas, 77001, United States

Location

Valeant Site 8

Houston, Texas, 77004, United States

Location

Valeant Site 46

Katy, Texas, 77449, United States

Location

Valeant Site 20

Pflugerville, Texas, 78660, United States

Location

Valeant Site 21

San Antonio, Texas, 78201, United States

Location

Valeant Site 7

San Antonio, Texas, 78202, United States

Location

Valeant Site 22

Webster, Texas, 77598, United States

Location

Valeant Site 38

Salt Lake City, Utah, 84101, United States

Location

Valeant Site 23

Lynchburg, Virginia, 24501, United States

Location

Valeant Site 26

Norfolk, Virginia, 23501, United States

Location

Valeant Site 42

Spokane, Washington, 99201, United States

Location

Results Point of Contact

• Title: Director of Clinical Operations
• Organization: Bausch Health Americas, Inc.

aloncaric@bauschhealth.com

1-510-259-5284

Study Officials

• Binu J Alexander

  Valeant Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2015
• First Posted: June 3, 2015
• Study Start: August 11, 2015
• Primary Completion: January 31, 2017
• Study Completion: April 24, 2017
• Last Updated: January 27, 2020
• Results First Posted: January 27, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (46)