Plaque PsoriasisPhase 3NCT02886702

A Study Comparing Tazarotene Cream 0.05% to TAZORAC® (Tazarotene) Cream 0.05% and Both to a Placebo Control in the Treatment of Plaque Psoriasis

A Phase 3 study testing Tazarotene Cream 0.05% and TAZORAC® (tazarotene) Cream 0.05% in people with Plaque Psoriasis, run by Fougera Pharmaceuticals Inc. at 30 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Tazarotene Cream 0.05% to TAZORAC® (tazarotene) Cream 0.05% and Both Active Treatments to a Vehicle Control in the Treatment of Stable Plaque Psoriasis 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?: Tazarotene Cream 0.05% and TAZORAC® (tazarotene) Cream 0.05%
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 855 participants
Where: 30 sitesUnited States
Study dates: 19 Sep 2016to 2 Aug 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

Have a definite clinical diagnosis of stable (at least 6 months) plaque psoriasis, involving at least 2% and no more than 20% of the body surface area (BSA) (not including the scalp and intertriginous areas)
Have a minimum plaque elevation at the target lesion site of at least moderate severity (grade ≥ 3 on the Psoriasis Area Severity Index [PASI]). The most severe lesion at baseline should be identified as the target lesion
Have an Investigator's Global Assessment (IGA) of disease severity of at least moderate (score ≥ 3) as an overall assessment of all lesions to be treated.

Who cannot join

A female subject who is pregnant, nursing, planning a pregnancy, or does not agree to use an acceptable form of birth control within the study participation period
Have a current diagnosis of unstable forms of psoriasis in the treatment area, including pustular, guttate, exfoliative or erythrodermic psoriasis
Have a history of psoriasis unresponsive to topical treatments

Trial locations and contacts

30 sites in 1 country.

City, postcode or hospital

30 sites in 1 country

United States30 sites

Fougera Investigational Site
Anaheim, California, 92801
Fougera Investigational Site
Arlington Heights, Illinois, 60005
Fougera Investigational Site
Brandon, Florida, 33511
Fougera Investigational Site
Coral Gables, Florida, 33134
Fougera Investigational Site
Hazleton, Pennsylvania, 18201
Fougera Investigational Site
Henderson, Nevada, 89052
Fougera Investigational Site
Hialeah, Florida, 33016
Fougera Investigational Site
High Point, North Carolina, 27262
Fougera Investigational Site
Hot Springs, Arkansas, 71913
Fougera Investigational Site
Lake Charles, Louisiana, 70605
Fougera Investigational Site
Louisville, Kentucky, 40202
Fougera Investigational Site
Macon, Georgia, 31217
Fougera Investigational Site
Miami, Florida, 33015
Fougera Investigational Site
Miami, Florida, 33143
Fougera Investigational Site
Miami, Florida, 33175
Fougera Investigational Site
Miami Gardens, Florida, 33169
Fougera Investigational Site
Miramar, Florida, 33027
Fougera Investigational Site
New Albany, Indiana, 47150
Fougera Investigational Site
North Hollywood, California, 91606
Fougera Investigational Site
Phoenix, Arizona, 85018
Fougera Investigational Site
Plainfield, Indiana, 46168
Fougera Investigational Site
Saint Joseph, Missouri, 91606
Fougera Investigational Site
Salem, Oregon, 97302
Fougera Investigational Site
San Antonio, Texas, 78207
Fougera Investigational Site
San Diego, California, 92108
Fougera Investigational Site
San Ramon, California, 94582
Fougera Investigational Site
Sweetwater, Florida, 33172
Fougera Investigational Site
Tampa, Florida, 33618
Fougera Investigational Site
Upper Saint Clair, Pennsylvania, 15241
Fougera Investigational Site
West Palm Beach, Florida, 33406

Other trials in United States

About this study

Official title: A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Tazarotene Cream 0.05% to TAZORAC® (Tazarotene) Cream 0.05% and Both Active Treatments to a Vehicle Control in the Treatment of Stable Plaque Psoriasis

Conditions: Plaque Psoriasis
Being tested: Tazarotene Cream 0.05%, TAZORAC® (tazarotene) Cream 0.05%, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tazarotene Cream 0.05%Drug
Also called Tazarotene
Tazarotene Cream 0.05% to cover only the lesions with a thin film.
TAZORAC® (tazarotene) Cream 0.05%Drug
Also called Tazarotene
TAZORAC® (tazarotene) Cream 0.05% to cover only the lesions with a thin film.
PlaceboDrug
Also called Vehicle
Placebo (vehicle of the test product) to cover only the lesions with a thin film.

Study groups in NCT02886702
Study group	Role	What they receive
Test	Experimental	Tazarotene Cream 0.05% (Fougera Pharmaceuticals Inc.) Receives: Drug: Tazarotene Cream 0.05%
Reference	Active comparator	TAZORAC® (tazarotene) Cream 0.05% (Allergan, Inc.) Receives: Drug: TAZORAC® (tazarotene) Cream 0.05%
Placebo	Placebo comparator	Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.) Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Treatment Success Assessed by IGA
Proportion of subjects with treatment success (defined as none, minimal or mild disease, a score of 0, 1 or 2 within the treatment area) on the "Investigator's Global Assessment of Disease Severity" (IGA) at the Week 12 visit (Day 85 ± 4 days, End of Study).
Measured: Week 12

Secondary outcomes (2)

Disease Severity None or Minimal on IGA
Proportion of subjects with none or minimal disease, a score of 0 or 1 on the IGA at the Week 12 visit (Day 85 ± 4 days, End of Study).
Measured: Week 12
Target Site Plaque Elevation, Scaling and Erythema Scores of Less Than or Equal to 1 on the PASI
Proportion of subjects with target site plaque elevation, scaling and erythema scores of less than or equal to 1 (Clear or Almost Clear) on the Psoriasis Area Severity Index (PASI) at the Week 12 visit (Day 85 ± 4 days, End of Study).
Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Sep 20162 Aug 2017

First posted1 Sep 2016 (estimated)
Study start19 Sep 2016
Primary completion2 Aug 2017
Study completion2 Aug 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.
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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 855 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02886702
Sponsor's protocol ID: 0453-01-01
Other IDs: 0453
Status last verified: Jul 2018
First submitted: 29 Aug 2016
Last updated: 29 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of CS32582 in Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
Not yet recruitingPhase 3
A Study of Zasocitinib in Adults With Non-pustular Palmoplantar Psoriasis
Palmoplantar Psoriasis
RecruitingPhase 4
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)
Psoriasis, Overweight or Obesity
Active, not recruitingPhase 3
A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis

All Plaque Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Tazarotene Cream 0.05% to TAZORAC® (Tazarotene) Cream 0.05% and Both Active Treatments to a Vehicle Control in the Treatment of Stable Plaque Psoriasis
ClinicalTrials.gov ID: NCT02886702
Acronym / sponsor ID: 0453-01-01
Conditions: Plaque Psoriasis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 855 participants (actual)
Lead sponsor: Fougera Pharmaceuticals Inc.Industry (pharma, biotech, devices)
Study start: 19 Sep 2016 (actual)
Primary completion: 2 Aug 2017 (actual)
Study completion: 2 Aug 2017 (actual)
First posted: 1 Sep 2016 (estimated)
Results: Posted 29 Aug 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Test	Experimental	Drug: Tazarotene Cream 0.05%Tazarotene Cream 0.05% (Fougera Pharmaceuticals Inc.)
Reference	Active comparator	Drug: TAZORAC® (tazarotene) Cream 0.05%TAZORAC® (tazarotene) Cream 0.05% (Allergan, Inc.)
Placebo	Placebo comparator	Drug: PlaceboPlacebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Have a definite clinical diagnosis of stable (at least 6 months) plaque psoriasis, involving at least 2% and no more than 20% of the body surface area (BSA) (not including the scalp and intertriginous areas)
Have a minimum plaque elevation at the target lesion site of at least moderate severity (grade ≥ 3 on the Psoriasis Area Severity Index [PASI]). The most severe lesion at baseline should be identified as the target lesion
Have an Investigator's Global Assessment (IGA) of disease severity of at least moderate (score ≥ 3) as an overall assessment of all lesions to be treated.

Key exclusion criteria (3 listed)

A female subject who is pregnant, nursing, planning a pregnancy, or does not agree to use an acceptable form of birth control within the study participation period
Have a current diagnosis of unstable forms of psoriasis in the treatment area, including pustular, guttate, exfoliative or erythrodermic psoriasis
Have a history of psoriasis unresponsive to topical treatments

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
Tazarotene Cream 0.05%Also: TazaroteneTazarotene Cream 0.05% to cover only the lesions with a thin film.	Drug	Test
TAZORAC® (tazarotene) Cream 0.05%Also: TazaroteneTAZORAC® (tazarotene) Cream 0.05% to cover only the lesions with a thin film.	Drug	Reference
PlaceboAlso: VehiclePlacebo (vehicle of the test product) to cover only the lesions with a thin film.	Drug	Placebo

Primary outcome

Treatment Success Assessed by IGA
Time frame: Week 12
Proportion of subjects with treatment success (defined as none, minimal or mild disease, a score of 0, 1 or 2 within the treatment area) on the "Investigator's Global Assessment of Disease Severity" (IGA) at the Week 12 visit (Day 85 ± 4 days, End of Study).

2 secondary outcomes

Disease Severity None or Minimal on IGA
Time frame: Week 12
Target Site Plaque Elevation, Scaling and Erythema Scores of Less Than or Equal to 1 on the PASI
Time frame: Week 12

Results and safety

Results posted to the registry on 29 Aug 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Test	284	236
Reference	286	235
Placebo	285	232

Primary outcome: Treatment Success Assessed by IGA

Time frame: Week 12. Number. Unit: Percentage of Participants

Measure	Test n = 263	Reference n = 266	Placebo n = 275
Value	60.8	63.2	56.0

Test vs Reference: Risk Difference (RD): -4.5 (90% CI -12.6 to 3.6), Yates' corrected confidence interval
Test vs Placebo: p = 0.3520, Cochran-Mantel-Haenszel

Population analysed: mITT for superiority versus placebo, PP for equivalence versus Reference

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 85 days. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test	0 of 284 (0%)	31 of 284 (10.9%)	0 of 284
Reference	0 of 286 (0%)	24 of 286 (8.4%)	0 of 286
Placebo	3 of 285 (1.1%)	21 of 285 (7.4%)	0 of 285

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Plaque Psoriasis

Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of CS32582 in Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
Not yet recruitingPhase 3
A Study of Zasocitinib in Adults With Non-pustular Palmoplantar Psoriasis
Palmoplantar Psoriasis
RecruitingPhase 4
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)
Psoriasis, Overweight or Obesity
Active, not recruitingPhase 3
A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis

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.

Angela C. Kaplan study director

Fougera Pharmaceuticals Inc.

30 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 Tazarotene Cream 0.05% and TAZORAC® (tazarotene) Cream 0.05% in people with Plaque Psoriasis, run by Fougera Pharmaceuticals Inc. at 30 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 3 inclusion and 3 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 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 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. Some participants in this study may receive a placebo. 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 29 Aug 2018). 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?

Treatment Success Assessed by IGA (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02886702.

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 29 Aug 2018.