Plaque PsoriasisPhase 2NCT02045277
Safety and Efficacy of IDP 118 in the Treatment of Plaque Psoriasis
A Phase 2 study testing IDP-118 Lotion, IDP-118 Monad HP Lotion and IDP-118 Monad Taz Lotion in people with Plaque Psoriasis, run by Bausch Health Americas, Inc. at 18 sites in United States.
Trial summary
The objective of the study is to evaluate the safety and efficacy of a topical 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, IDP-118 Monad HP Lotion and IDP-118 Monad Taz Lotion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 18 sitesUnited States
- Study dates
- Feb 2014to Nov 2014
- Phase
- Phase 2
- 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 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, if psoriasis is present).
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
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Valeant Site 10
Augusta, Georgia, 30909
Valeant Site 05
Austin, Texas, 78759
Valeant Site 14
Clinton Township, Michigan, 48038
Valeant Site 06
College Station, Texas, 77845
Valeant Site 01
East Windsor, New Jersey, 08520
Valeant Site 13
Encino, California, 91436
Valeant Site 07
Fridley, Minnesota, 55432
Valeant Site 02
High Point, North Carolina, 27262
Valeant Site 08
Louisville, Kentucky, 40217
Valeant Site 18
Lynchburg, Virginia, 24501
Valeant Site 03
New York, New York, 10075
Valeant Site 09
Newnan, Georgia, 30263
Valeant Site 12
Norfolk, Virginia, 23507
Valeant Site 17
Rochester, New York, 14623
Valeant Site 04
Rockville, Maryland, 20850
Valeant Site 16
Salt Lake City, Utah, 84117
Valeant Site 11
San Diego, California, 92123
Valeant Site 15
Santa Rosa, California, 95403
About this study
Official title: A Phase 2, Multicenter, Double-Blind, Randomized, Vehicle Controlled Clinical Study to Assess the Safety and Efficacy of IDP 118 in the Treatment of Plaque Psoriasis
The objective of the study is to evaluate the safety and efficacy of a topical lotion
Read the detailed 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.
- Conditions
- Plaque Psoriasis
- Being tested
- IDP-118 Lotion, IDP-118 Monad HP Lotion, IDP-118 Monad Taz Lotion, IDP-118 Vehicle Lotion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IDP-118 LotionDrug
Also called Lotion
Lotion
IDP-118 Monad HP LotionDrug
Also called HP
Active Comparator
IDP-118 Monad Taz LotionDrug
Also called Taz
Active Comparator
IDP-118 Vehicle LotionDrug
Also called Vehicle
Vehicle
| Study group | Role | What they receive |
|---|---|---|
| IDP-118 Lotion | Experimental | halobetasol propionate [HP], tazarotene [Taz] Receives: Drug: IDP-118 Lotion |
| IDP-118 Monad HP Lotion | Active comparator | HP Receives: Drug: IDP-118 Monad HP Lotion |
| IDP-118 Monad Taz Lotion | Active comparator | Taz Receives: Drug: IDP-118 Monad Taz Lotion |
| IDP-118 Vehicle Lotion | Active comparator | Vehicle Receives: Drug: IDP-118 Vehicle Lotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Treatment Success of a 2-Grade IGA Score Improvement From Baseline and an IGA Score of Clear or Almost Clear at Week 8
Treatment success defined as at least a 2-grade improvement from Baseline in the IGA score and an IGA score equating to "clear" or "almost clear" at Week 8. The IGA score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe).
Measured: 8 weeks
Percentage of Participants With Treatment Success of a 2-Grade IGA Score Improvement From Baseline and an IGA Score of Clear or Almost Clear at Weeks 2, 4, 6, and 12
Treatment success defined as at least a 2-grade improvement from Baseline in the Investigator's Global Assessment (IGA) score and an IGA score equating to "clear" or "almost clear" at Weeks 2, 4, 6, and 12. The IGA score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe).
Measured: Weeks 2, 4, 6, and 12 (4-week follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionNov 2014
- Study completionNov 2014
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 212 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
- NCT02045277
- Sponsor's protocol ID
- V01-118A-201
- Status last verified
- Aug 2020
- First submitted
- 22 Jan 2014
- Last updated
- 20 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Double-Blind, Randomized, Vehicle Controlled Clinical Study to Assess the Safety and Efficacy of IDP 118 in the Treatment of Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT02045277
- Acronym / sponsor ID
- V01-118A-201
- Conditions
- Plaque Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Dow Pharmaceutical Sciences
- Study start
- Feb 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 24 Jan 2014 (estimated)
- Results
- Posted 20 Aug 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 the study is to evaluate the safety and efficacy of a topical lotion
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| IDP-118 Lotion | Experimental | Drug: IDP-118 Lotionhalobetasol propionate [HP], tazarotene [Taz] |
| IDP-118 Monad HP Lotion | Active comparator | Drug: IDP-118 Monad HP LotionHP |
| IDP-118 Monad Taz Lotion | Active comparator | Drug: IDP-118 Monad Taz LotionTaz |
| IDP-118 Vehicle Lotion | Active comparator | Drug: IDP-118 Vehicle LotionVehicle |
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 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, if psoriasis is present).
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 LotionAlso: LotionLotion | Drug | IDP-118 Lotion |
| IDP-118 Monad HP LotionAlso: HPActive Comparator | Drug | IDP-118 Monad HP Lotion |
| IDP-118 Monad Taz LotionAlso: TazActive Comparator | Drug | IDP-118 Monad Taz Lotion |
| IDP-118 Vehicle LotionAlso: VehicleVehicle | Drug | IDP-118 Vehicle Lotion |
Primary outcome
Percentage of Participants With Treatment Success of a 2-Grade IGA Score Improvement From Baseline and an IGA Score of Clear or Almost Clear at Week 8
Time frame: 8 weeks
Treatment success defined as at least a 2-grade improvement from Baseline in the IGA score and an IGA score equating to "clear" or "almost clear" at Week 8. The IGA score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe).
Percentage of Participants With Treatment Success of a 2-Grade IGA Score Improvement From Baseline and an IGA Score of Clear or Almost Clear at Weeks 2, 4, 6, and 12
Time frame: Weeks 2, 4, 6, and 12 (4-week follow-up)
Treatment success defined as at least a 2-grade improvement from Baseline in the Investigator's Global Assessment (IGA) score and an IGA score equating to "clear" or "almost clear" at Weeks 2, 4, 6, and 12. The IGA score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
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A Study to Investigate the Effectiveness of Tirzepatide (LY3298176) Following Initiation of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque PsO and Obesity or Overweight in Clinical Practice (TOGETHER AMPLIFY-PsO)
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A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
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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
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IDP-118 Lotion, IDP-118 Monad HP Lotion and IDP-118 Monad Taz Lotion in people with Plaque Psoriasis, run by Bausch Health Americas, Inc. at 18 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 20 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 20 Aug 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 With Treatment Success of a 2-Grade IGA Score Improvement From Baseline and an IGA Score of Clear or Almost Clear at Week 8 (time frame: 8 weeks). The study lists 2 primary outcomes in all. 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 20 Aug 2020.