Plaque PsoriasisPhase 3NCT02462083
Long-Term Safety of IDP-118 Lotion in the Treatment of Plaque Psoriasis
A Phase 3 study testing IDP-118 Lotion in people with Plaque Psoriasis, run by Bausch Health Americas, Inc. at 46 sites in United States.
Trial summary
The objective of this study is to evaluate the long-term safety of IDP-118 lotion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- IDP-118 Lotion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 555 participants
- Where
- 46 sitesUnited States
- Study dates
- 11 Aug 2015to 24 Apr 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
46 sites in 1 country.
46 sites in 1 country
United States46 sites
Valeant Site 24
Beverly Hills, California, 90210
Valeant Site 3
Boynton Beach, Florida, 33424
Valeant Site 30
Charleston, South Carolina, 29401
Valeant Site 35
Clinton Township, Michigan, 48036
Valeant Site 28
Coral Gables, Florida, 33134
Valeant Site 9
Dallas, Texas, 75201
Valeant Site 34
Detroit, Michigan, 48201
Valeant Site 2
East Windsor, New Jersey, 08520
Valeant Site 32
Encinitas, California, 92023
Valeant Site 27
Encino, California, 91436
Valeant Site 10
Englewood, Colorado, 80113
Valeant Site 18
Fridley, Minnesota, 55421
Valeant Site 40
Houston, Texas, 77001
Valeant Site 8
Houston, Texas, 77004
Valeant Site 46
Katy, Texas, 77449
Valeant Site 33
Los Angeles, California, 90001
Valeant Site 43
Los Angeles, California, 90002
Valeant Site 19
Louisville, Kentucky, 40201
Valeant Site 14
Louisville, Kentucky, 40205
Valeant Site 23
Lynchburg, Virginia, 24501
Valeant Site 1
Miami, Florida, 33101
Valeant Site 6
Mobile, Alabama, 36603
Valeant Site 15
Nashville, Tennessee, 37115
Valeant Site 29
New York, New York, 10001
Valeant Site 26
Norfolk, Virginia, 23501
Valeant Site 37
North Miami Beach, Florida, 33160
Valeant Site 12
Olathe, Kansas, 66051
Valeant Site 31
Omaha, Nebraska, 68022
Valeant Site 20
Pflugerville, Texas, 78660
Valeant Site 11
Philadelphia, Pennsylvania, 19019
Valeant Site 5
Portland, Oregon, 97201
Valeant Site 39
Rochester, New York, 14603
Valeant Site 45
Sacramento, California, 94203
Valeant Site 38
Salt Lake City, Utah, 84101
Valeant Site 21
San Antonio, Texas, 78201
Valeant Site 7
San Antonio, Texas, 78202
Valeant Site 25
San Diego, California, 92093
Valeant Site 4
San Diego, California, 92093
Valeant Site 13
Sanford, Florida, 32771
Valeant Site 44
Santa Monica, California, 90401
Valeant Site 36
Santa Rosa, California, 95401
Valeant Site 41
Snellville, Georgia, 30039
Valeant Site 17
South Bend, Indiana, 46601
Valeant Site 42
Spokane, Washington, 99201
Valeant Site 16
Warren, Michigan, 48088
Valeant Site 22
Webster, Texas, 77598
About this study
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
The objective of this study is to evaluate the long-term safety of IDP-118 lotion.
Read the detailed description
This is a multicenter, open-label study of the long-term safety of IDP-118 lotion in participants with plaque psoriasis.
- Conditions
- Plaque Psoriasis
- Being tested
- IDP-118 Lotion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IDP-118 LotionDrug
IDP-118 lotion will be applied as per the instructions provided by the investigational center staff.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: IDP-118 Lotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2015 (estimated)
- Study start11 Aug 2015
- Primary completion31 Jan 2017
- Study completion24 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- More trials run by Bausch Health Americas, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 555 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dow Pharmaceutical Sciences
- Responsible party
- Sponsor
- Investigators
- Binu J Alexander, Study director, Valeant Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02462083
- Sponsor's protocol ID
- V01-118A-303
- Status last verified
- Jan 2020
- First submitted
- 1 Jun 2015
- Last updated
- 27 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02462083
- Acronym / sponsor ID
- V01-118A-303
- Conditions
- Plaque Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 555 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Dow Pharmaceutical Sciences
- Study start
- 11 Aug 2015 (actual)
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- 24 Apr 2017 (actual)
- First posted
- 3 Jun 2015 (estimated)
- Results
- Posted 27 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IDP-118 Lotion | Experimental | Drug: IDP-118 LotionIDP-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IDP-118 LotionIDP-118 lotion will be applied as per the instructions provided by the investigational center staff. | Drug | IDP-118 Lotion |
Primary outcome
Percentage of Participants Who Experienced Grade 3 Local Skin Reactions
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Binu J Alexander study director
Valeant Pharmaceuticals
46 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IDP-118 Lotion in people with Plaque Psoriasis, run by Bausch Health Americas, Inc. at 46 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Experienced Grade 3 Local Skin Reactions (time frame: Baseline up to Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.