PsoriasisPhase 2NCT02785159
Safety and Efficacy of IDP-118 Lotion in the Treatment of Plaque Psoriasis
A Phase 2 study testing IDP-118 Lotion and Tazorac Cream in people with Psoriasis, run by Bausch Health Americas, Inc. at 14 sites in United States.
Trial summary
Safety and Efficacy of IDP-118 Lotion in the Treatment of Plaque Psoriasis Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- IDP-118 Lotion and Tazorac Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 14 sitesUnited States
- Study dates
- Feb 2016to Dec 2016
- 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
- Healthy volunteers accepted
- 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%, 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) Investigator Global Assessment 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
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Valeant Site 02
Charlottesville, Virginia, 22901
Valeant Site 09
Clarkston, Michigan, 48346
Valeant Site 06
College Station, Texas, 77840
Valeant Site 12
Encino, California, 91316
Valeant Site 07
Fridley, Minnesota, 55421
Valeant Site 10
Greenville, South Carolina, 29601
Valeant Site 03
Murfreesboro, Tennessee, 37129
Valeant Site 13
Orange Park, Florida, 32065
Valeant Site 11
Pinellas Park, Florida, 33780
Valeant Site 05
Plainfield, Indiana, 46168
Valeant Site 14
Saint Joseph, Missouri, 64501
Valeant Site 01
Tampa, Florida, 33601
Valeant Site 04
Tampa, Florida, 33601
Valeant Site 08
Webster, Texas, 77598
About this study
Official title: A Phase 2, Multicenter, Double Blinded, Randomized, Vehicle Controlled Study to Compare the Safety and Efficacy of IDP-118 Lotion With Tazorac (Tazarotene) Cream, 0.05% in the Treatment of Plaque Psoriasis
Safety and Efficacy of IDP-118 Lotion in the Treatment of Plaque Psoriasis
Read the detailed description
A Phase 2, Multicenter, Double-Blinded, Randomized, Vehicle-Controlled Study to Compare the Safety and Efficacy of IDP-118 Lotion with Tazorac (tazarotene) Cream, 0.05% in the Treatment of Plaque Psoriasis
- Conditions
- Psoriasis
- Being tested
- IDP-118 Lotion, Tazorac Cream, IDP-118 Vehicle Lotion, IDP-118 Vehicle Cream
- Medical subject headings
- Psoriasis
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
Tazorac CreamDrug
Also called Tazorac
Cream
IDP-118 Vehicle LotionDrug
Also called Vehicle
Lotion
IDP-118 Vehicle CreamDrug
Also called Vehicle
Cream
| Study group | Role | What they receive |
|---|---|---|
| IDP-118 Lotion | Experimental | Lotion Receives: Drug: IDP-118 Lotion |
| Tazorac Cream | Active comparator | Cream Receives: Drug: Tazorac Cream |
| IDP 118 Vehicle Lotion | Active comparator | Lotion Receives: Drug: IDP-118 Vehicle Lotion |
| IDP-118 Vehicle Cream | Active comparator | Cream Receives: Drug: IDP-118 Vehicle Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Subjects With Treatment Success, Defined by at Least a 2 Grade Improvement From Baseline in the Investigator Global Assessment (IGA) Score Equating to Clear or Almost Clear.
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". 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: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2016 (estimated)
- Study startFeb 2016
- Primary completion20 Nov 2016
- Study completionDec 2016
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 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Binu J Alexander, MD, Study director, Valeant Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02785159
- Sponsor's protocol ID
- V01-118A-202
- Status last verified
- Aug 2020
- First submitted
- 26 Apr 2016
- Last updated
- 20 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 Blinded, Randomized, Vehicle Controlled Study to Compare the Safety and Efficacy of IDP-118 Lotion With Tazorac (Tazarotene) Cream, 0.05% in the Treatment of Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT02785159
- Acronym / sponsor ID
- V01-118A-202
- Conditions
- Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- 20 Nov 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 27 May 2016 (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.
Safety and Efficacy of IDP-118 Lotion in the Treatment of Plaque Psoriasis
Detailed description
A Phase 2, Multicenter, Double-Blinded, Randomized, Vehicle-Controlled Study to Compare the Safety and Efficacy of IDP-118 Lotion with Tazorac (tazarotene) Cream, 0.05% in the Treatment of Plaque Psoriasis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| IDP-118 Lotion | Experimental | Drug: IDP-118 LotionLotion |
| Tazorac Cream | Active comparator | Drug: Tazorac CreamCream |
| IDP 118 Vehicle Lotion | Active comparator | Drug: IDP-118 Vehicle LotionLotion |
| IDP-118 Vehicle Cream | Active comparator | Drug: IDP-118 Vehicle CreamCream |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- 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%, 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) Investigator Global Assessment 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 |
| Tazorac CreamAlso: TazoracCream | Drug | Tazorac Cream |
| IDP-118 Vehicle LotionAlso: VehicleLotion | Drug | IDP 118 Vehicle Lotion |
| IDP-118 Vehicle CreamAlso: VehicleCream | Drug | IDP-118 Vehicle Cream |
Primary outcome
Percent of Subjects With Treatment Success, Defined by at Least a 2 Grade Improvement From Baseline in the Investigator Global Assessment (IGA) Score Equating to Clear or Almost Clear.
Time frame: 12 Weeks
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". 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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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, MD study director
Valeant Pharmaceuticals
14 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 and Tazorac Cream in people with Psoriasis, run by Bausch Health Americas, Inc. at 14 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 14 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?
Percent of Subjects With Treatment Success, Defined by at Least a 2 Grade Improvement From Baseline in the Investigator Global Assessment (IGA) Score Equating to Clear or Almost Clear. (time frame: 12 Weeks). 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.