Long-Term Safety of IDP-118 Lotion in the Treatment of Plaque Psoriasis
- Conditions
- Plaque Psoriasis
- Interventions
- Drug: IDP-118 Lotion
- Registration Number
- NCT02462083
- Lead Sponsor
- Bausch Health Americas, Inc.
- Brief Summary
The objective of this study is to evaluate the long-term safety of IDP-118 lotion.
- Detailed Description
This is a multicenter, open-label study of the long-term safety of IDP-118 lotion in participants with plaque psoriasis.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 555
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description IDP-118 Lotion IDP-118 Lotion 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants Who Experienced Grade 3 Local Skin Reactions Baseline up to Week 52 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (46)
Valeant Site 6
🇺🇸Mobile, Alabama, United States
Valeant Site 43
🇺🇸Los Angeles, California, United States
Valeant Site 44
🇺🇸Santa Monica, California, United States
Valeant Site 17
🇺🇸South Bend, Indiana, United States
Valeant Site 11
🇺🇸Philadelphia, Pennsylvania, United States
Valeant Site 9
🇺🇸Dallas, Texas, United States
Valeant Site 40
🇺🇸Houston, Texas, United States
Valeant Site 25
🇺🇸San Diego, California, United States
Valeant Site 4
🇺🇸San Diego, California, United States
Valeant Site 21
🇺🇸San Antonio, Texas, United States
Valeant Site 7
🇺🇸San Antonio, Texas, United States
Valeant Site 46
🇺🇸Katy, Texas, United States
Valeant Site 12
🇺🇸Olathe, Kansas, United States
Valeant Site 34
🇺🇸Detroit, Michigan, United States
Valeant Site 5
🇺🇸Portland, Oregon, United States
Valeant Site 15
🇺🇸Nashville, Tennessee, United States
Valeant Site 38
🇺🇸Salt Lake City, Utah, United States
Valeant Site 24
🇺🇸Beverly Hills, California, United States
Valeant Site 27
🇺🇸Encino, California, United States
Valeant Site 32
🇺🇸Encinitas, California, United States
Valeant Site 33
🇺🇸Los Angeles, California, United States
Valeant Site 10
🇺🇸Englewood, Colorado, United States
Valeant Site 36
🇺🇸Santa Rosa, California, United States
Valeant Site 3
🇺🇸Boynton Beach, Florida, United States
Valeant Site 28
🇺🇸Coral Gables, Florida, United States
Valeant Site 1
🇺🇸Miami, Florida, United States
Valeant Site 37
🇺🇸North Miami Beach, Florida, United States
Valeant Site 41
🇺🇸Snellville, Georgia, United States
Valeant Site 35
🇺🇸Clinton Township, Michigan, United States
Valeant Site 16
🇺🇸Warren, Michigan, United States
Valeant Site 18
🇺🇸Fridley, Minnesota, United States
Valeant Site 29
🇺🇸New York, New York, United States
Valeant Site 2
🇺🇸East Windsor, New Jersey, United States
Valeant Site 39
🇺🇸Rochester, New York, United States
Valeant Site 20
🇺🇸Pflugerville, Texas, United States
Valeant Site 8
🇺🇸Houston, Texas, United States
Valeant Site 23
🇺🇸Lynchburg, Virginia, United States
Valeant Site 26
🇺🇸Norfolk, Virginia, United States
Valeant Site 42
🇺🇸Spokane, Washington, United States
Valeant Site 13
🇺🇸Sanford, Florida, United States
Valeant Site 22
🇺🇸Webster, Texas, United States
Valeant Site 45
🇺🇸Sacramento, California, United States
Valeant Site 19
🇺🇸Louisville, Kentucky, United States
Valeant Site 14
🇺🇸Louisville, Kentucky, United States
Valeant Site 31
🇺🇸Omaha, Nebraska, United States
Valeant Site 30
🇺🇸Charleston, South Carolina, United States