Acne VulgarisPhase 3NCT02886715

A Study Comparing Tazarotene Cream 0.1% to TAZORAC® (Tazarotene) Cream 0.1% and Both to a Placebo Control in the Treatment of Acne Vulgaris

A Phase 3 study testing Tazarotene Cream 0.1% and Tazorac® in people with Acne Vulgaris, run by Fougera Pharmaceuticals Inc. at 25 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 0.1% to TAZORAC® (Tazarotene) Cream 0.1% and Both Active Treatments to a Vehicle Control in the Treatment of Acne Vulgaris Read more about this study

Who is it for?: Ages 12 to 40 years
Conditions the study is for: Acne Vulgaris
What is being tested?: Tazarotene Cream 0.1% and Tazorac®
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,110 participants
Where: 25 sitesUnited States
Study dates: 21 Sep 2016to 31 May 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 12 to 40 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Healthy male or non-pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
Must have a minimum of ≥ 25 non-inflammatory lesions and ≥ 20 inflammatory lesions and ≤ 2 nodulocystic lesions at baseline on the face.
Must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment.

Who cannot join

Female subjects who are pregnant, nursing or planning to become pregnant during study participation.
Have a history of hypersensitivity or allergy to tazarotene, retinoids and/or any of the study medication ingredients.
Presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris.

Trial locations and contacts

25 sites in 1 country.

City, postcode or hospital

25 sites in 1 country

United States25 sites

Fougera Investigational Site
Anaheim, California, 92801
Fougera Investigational Site
Austin, Texas, 78759
Fougera Investigational Site
Chattanooga, Tennessee, 37421
Fougera Investigational Site
Conway, Arkansas, 72034
Fougera Investigational Site
Coral Gables, Florida, 33134
Fougera Investigational Site
Hazleton, Pennsylvania, 18201
Fougera Investigational Site
High Point, North Carolina, 27262
Fougera Investigational Site
Hot Springs, Arkansas, 71913
Fougera Investigational Site
La Mesa, California, 91942
Fougera Investigational Site
Long Beach, California, 90806
Fougera Investigational Site
Long Beach, California, 90813
Fougera Investigational Site
Los Angeles, California, 90010
Fougera Investigational Site
Miami, Florida, 33015
Fougera Investigational Site
Miami, Florida, 33175
Fougera Investigational Site
Miami Gardens, Florida, 33169
Fougera Investigational Site
Miramar, Florida, 33027
Fougera Investigational Site
North Hollywood, California, 91606
Fougera Investigational Site
Plainfield, Indiana, 46168
Fougera Investigational Site
San Diego, California, 92108
Fougera Investigational Site
San Ramon, California, 94582
Fougera Investigational Site
Sweetwater, Florida, 33172
Fougera Investigational Site
Tucson, Arizona, 85712
Fougera Investigational Site
Upland, California, 91786
Fougera Investigational Site
Upper Saint Clair, Pennsylvania, 15241
Fougera Investigational Site
West Covina, California, 91790

Other trials in United States

About this study

Official title: A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Tazarotene Cream 0.1% to TAZORAC® (Tazarotene) Cream 0.1% and Both Active Treatments to a Vehicle Control in the Treatment of Acne Vulgaris

Conditions: Acne Vulgaris
Being tested: Tazarotene Cream 0.1%, Tazorac®, Placebo
Medical subject headings: Acne Vulgaris

What participants receive

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

Tazarotene Cream 0.1%Drug
Also called Tazarotene
Tazarotene Cream 0.1% applied to cover the affected areas of the face once daily for 84 +/- 4 days.
Tazorac®Drug
Also called Tazarotene
Tazorac® applied to cover the affected areas of the face once daily for 84 +/- 4 days.
PlaceboDrug
Also called Vehicle
Placebo (vehicle of the test product) applied to cover the affected areas of the face once daily for 84 +/- 4 days.

Study groups in NCT02886715
Study group	Role	What they receive
Test	Experimental	Tazarotene Cream 0.1% (Fougera Pharmaceuticals Inc.) Receives: Drug: Tazarotene Cream 0.1%
Reference	Active comparator	TAZORAC® (tazarotene) Cream, 0.1% (Allergan, Inc.) Receives: Drug: Tazorac®
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.

Change in Inflammatory Lesion Counts
Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts
Measured: Week 12
Change in Non-inflammatory Lesion Counts
Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts
Measured: Week 12

Secondary outcomes (1)

Clinical Response of Success
The proportion of subjects with a clinical response of success at week 12, success defined as an Investigator's Global Assessment score that is at least two grades less than the baseline assessment
Measured: Week 12

Timeline

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

21 Sep 201631 May 2017

First posted1 Sep 2016 (estimated)
Study start21 Sep 2016
Primary completion31 May 2017
Study completion31 May 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 Acne VulgarisStudies 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: 1,110 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02886715
Sponsor's protocol ID: 0454-01-01
Other IDs: 0454
Status last verified: Jul 2018
First submitted: 29 Aug 2016
Last updated: 17 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

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Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
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All Acne Vulgaris trials

Study at a glance

From the registry record, last updated by the sponsor on 17 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 0.1% to TAZORAC® (Tazarotene) Cream 0.1% and Both Active Treatments to a Vehicle Control in the Treatment of Acne Vulgaris
ClinicalTrials.gov ID: NCT02886715
Acronym / sponsor ID: 0454-01-01
Conditions: Acne Vulgaris
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,110 participants (actual)
Lead sponsor: Fougera Pharmaceuticals Inc.Industry (pharma, biotech, devices)
Study start: 21 Sep 2016 (actual)
Primary completion: 31 May 2017 (actual)
Study completion: 31 May 2017 (actual)
First posted: 1 Sep 2016 (estimated)
Results: Posted 17 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 0.1%Tazarotene Cream 0.1% (Fougera Pharmaceuticals Inc.)
Reference	Active comparator	Drug: Tazorac®TAZORAC® (tazarotene) Cream, 0.1% (Allergan, Inc.)
Placebo	Placebo comparator	Drug: PlaceboPlacebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)

Who may qualify

Ages: 12 to 40 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (3 listed)

Healthy male or non-pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
Must have a minimum of ≥ 25 non-inflammatory lesions and ≥ 20 inflammatory lesions and ≤ 2 nodulocystic lesions at baseline on the face.
Must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment.

Key exclusion criteria (3 listed)

Female subjects who are pregnant, nursing or planning to become pregnant during study participation.
Have a history of hypersensitivity or allergy to tazarotene, retinoids and/or any of the study medication ingredients.
Presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris.

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 0.1%Also: TazaroteneTazarotene Cream 0.1% applied to cover the affected areas of the face once daily for 84 +/- 4 days.	Drug	Test
Tazorac®Also: TazaroteneTazorac® applied to cover the affected areas of the face once daily for 84 +/- 4 days.	Drug	Reference
PlaceboAlso: VehiclePlacebo (vehicle of the test product) applied to cover the affected areas of the face once daily for 84 +/- 4 days.	Drug	Placebo

Primary outcome

Change in Inflammatory Lesion Counts
Time frame: Week 12
Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts
Change in Non-inflammatory Lesion Counts
Time frame: Week 12
Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts

1 secondary outcome

Clinical Response of Success
Time frame: Week 12

Results and safety

Results posted to the registry on 17 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	442	378
Reference	445	390
Placebo	223	203

Primary outcome: Change in Inflammatory Lesion Counts

Time frame: Week 12. Least squares mean (Standard Error). Unit: percent change

Measure	Test n = 421	Reference n = 418	Placebo n = 217
Value	-58.44 (1.33)	-60.07 (1.32)	-53.28 (1.81)

Test vs Reference: Test-to-Reference Ratio: 98.75 (90% CI 94.39 to 103.31), ANOVA
Test vs Placebo: Mean Difference (Final Values): -5.17 (95% CI -9.46 to -0.87), p = 0.0185, ANOVA

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

Primary outcome: Change in Non-inflammatory Lesion Counts

Time frame: Week 12. Least squares mean (Standard Error). Unit: percent change

Measure	Test n = 421	Reference n = 418	Placebo n = 217
Value	-50.11 (1.27)	-51.99 (1.26)	-45.72 (1.73)

Test vs Reference: Test-to-Reference Ratio: 98.39 (90% CI 93.42 to 103.61), ANOVA
Test vs Placebo: Mean Difference (Final Values): -4.39 (95% CI -8.48 to -0.30), p = 0.0354, ANOVA

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

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From baseline to week 12 (end of study). Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test	1 of 442 (0.2%)	45 of 442 (10.2%)	0 of 442
Reference	0 of 445 (0%)	57 of 445 (12.8%)	0 of 445
Placebo	0 of 223 (0%)	12 of 223 (5.4%)	0 of 223

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Acne Vulgaris

Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
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RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
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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.

Angela C. Kaplan study director

Fougera Pharmaceuticals Inc.

25 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 0.1% and Tazorac® in people with Acne Vulgaris, run by Fougera Pharmaceuticals Inc. at 25 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 17 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 25 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 17 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?

Change in Inflammatory Lesion Counts (time frame: Week 12). 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?

On the ClinicalTrials.gov record for NCT02886715.

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 17 Aug 2018.