Acne VulgarisPhase 4NCT00829049

Safety and Efficacy of Tazarotene Cream 0.1% Compared With Adapalene Gel 0.3% in the Treatment of Moderate to Severe Facial Acne Vulgaris

A Phase 4 study testing Tazarotene Cream 0.1% and Adapalene in people with Acne Vulgaris, run by Allergan at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Comparison of the safety and efficacy of Tazarotene Cream 0.1% compared with Adapalene Gel 0.3% in treating moderate to severe facial acne vulgaris Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: Acne Vulgaris
What is being tested?: Tazarotene Cream 0.1% and Adapalene
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 165 participants
Where: 1 siteUnited States
Study dates: Oct 2007to Oct 2008
Phase: Phase 4
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 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Facial acne vulgaris characterized by the following: 25-100 facial inflammatory lesions (papules plus pustules); and 40 or more non-inflammatory lesions (open/closed comedones)); stable disease, non-rapidly regressing facial acne vulgaris; and, 3 or less facial nodules and/or cysts (diameter of 1cm or greater).
Female subjects of childbearing potential must have a negative urine pregnancy test at baseline and practice reliable method of contraception throughout the study.

Who cannot join

Non-compliance with washout period
Skin disease/disorder that might interfere with diagnosis or evaluation of acne vulgaris
Allergy or sensitivity to any component of the test medications
Cosmetic or surgical procedure complementary to the treatment of facial acne within 14 days of the baseline visit

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Fremont, California

Other trials in United States

About this study

Comparison of the safety and efficacy of Tazarotene Cream 0.1% compared with Adapalene Gel 0.3% in treating moderate to severe facial acne vulgaris

Conditions: Acne Vulgaris
Being tested: Tazarotene Cream 0.1%, Adapalene
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 TAZORAC® Cream 0.1%
1 pea-size amount, QD x 16 weeks
AdapaleneDrug
Also called Differin® Gel 0.3%
1 pea-size amount, QD x 16 weeks

Study groups in NCT00829049
Study group	Role	What they receive
Tazarotene Cream 0.1%	Active comparator	1 pea-size amount, QD x 16 weeks Receives: Drug: Tazarotene Cream 0.1%
Adapalene Gel 0.3%	Active comparator	1 pea-size amount, QD x 16 weeks Receives: Drug: Adapalene

What is being measured

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

Median Percent Change From Baseline in the Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12
Median percent change from baseline in the non-inflammatory lesion counts (open and closed comedones) at Week 12. Comedones are small bumps on the skin (lesions) caused by acne and found at the opening of a skin pore. Open comedones (also known as blackheads) have a microscopic opening to the skin surface, while closed comedones (also known as whiteheads or pimples) lack the opening to the skin. A negative number change from baseline indicates a reduction in lesion counts(improvement).
Measured: Baseline, Week 12

Secondary outcomes (3)

Percentage of Patients With >= 1 Grade Improvement in the Investigator Global Assessment at Week 16
Percentage of patients with >= 1 grade improvement (decrease in score) in the Investigator Global Assessment (IGA) at Week 16. The IGA is a 5-point scale used by the investigator to assess overall acne severity, where 0 equals clear skin (no evidence of acne) and 4 equals severe acne.
Measured: Week 16
Percentage of Patients With >= 2 Grade Improvement in the Overall Disease Severity Score at Week 12
Percentage of patients with >= 2 grade improvement (decrease in score) in the overall disease severity score at Week 12. The overall disease severity score was evaluated by the investigator using a 7-point scale to rate the overall acne severity (lesions, inflammation, facial redness, and skin condition), where 0=no acne lesions and 6=most severe acne.
Measured: Week 12
Median Percent Change From Baseline in Inflammatory Lesion Counts (Papules/Pustules, Nodules) at Week 16
Median percent change from baseline in inflammatory lesion counts (papules/pustules, nodules) at Week 16. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 to 10 millimeters in width and depth) and nodules are larger (greater than 5 to 10 millimeters in width and depth). Pustules are small elevations of the skin containing cloudy material. A negative number change from baseline indicates a reduction in lesion counts (improvement).
Measured: Baseline, Week 16

Timeline

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

Oct 2007Oct 2008

First posted26 Jan 2009 (estimated)
Study startOct 2007
Primary completionOct 2008
Study completionOct 2008

Why it stopped: Study enrollment was terminated due to company decision before the target enrollment of 220 patients was reached.

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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 165 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00829049
Sponsor's protocol ID: MA-TAZ0702
Status last verified: Aug 2012
First submitted: 22 Jan 2009
Last updated: 12 Sep 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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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All Acne Vulgaris trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of Tazarotene Cream 0.1% Compared With Adapalene Gel 0.3% in the Treatment of Moderate to Severe Facial Acne Vulgaris
ClinicalTrials.gov ID: NCT00829049
Acronym / sponsor ID: MA-TAZ0702
Conditions: Acne Vulgaris
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study enrollment was terminated due to company decision before the target enrollment of 220 patients was reached.
Enrolment: 165 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: Oct 2007
Primary completion: Oct 2008 (actual)
Study completion: Oct 2008 (actual)
First posted: 26 Jan 2009 (estimated)
Results: Posted 12 Sep 2012

Clinical summary

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

Comparison of the safety and efficacy of Tazarotene Cream 0.1% compared with Adapalene Gel 0.3% in treating moderate to severe facial acne vulgaris

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Tazarotene Cream 0.1%	Active comparator	Drug: Tazarotene Cream 0.1%1 pea-size amount, QD x 16 weeks
Adapalene Gel 0.3%	Active comparator	Drug: Adapalene1 pea-size amount, QD x 16 weeks

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

Facial acne vulgaris characterized by the following: 25-100 facial inflammatory lesions (papules plus pustules); and 40 or more non-inflammatory lesions (open/closed comedones)); stable disease, non-rapidly regressing facial acne vulgaris; and, 3 or less facial nodules and/or cysts (diameter of 1cm or greater).
Female subjects of childbearing potential must have a negative urine pregnancy test at baseline and practice reliable method of contraception throughout the study.

Key exclusion criteria (4 listed)

Non-compliance with washout period
Skin disease/disorder that might interfere with diagnosis or evaluation of acne vulgaris
Allergy or sensitivity to any component of the test medications
Cosmetic or surgical procedure complementary to the treatment of facial acne within 14 days of the baseline visit

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: TAZORAC® Cream 0.1%1 pea-size amount, QD x 16 weeks	Drug	Tazarotene Cream 0.1%
AdapaleneAlso: Differin® Gel 0.3%1 pea-size amount, QD x 16 weeks	Drug	Adapalene Gel 0.3%

Primary outcome

Median Percent Change From Baseline in the Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12
Time frame: Baseline, Week 12
Median percent change from baseline in the non-inflammatory lesion counts (open and closed comedones) at Week 12. Comedones are small bumps on the skin (lesions) caused by acne and found at the opening of a skin pore. Open comedones (also known as blackheads) have a microscopic opening to the skin surface, while closed comedones (also known as whiteheads or pimples) lack the opening to the skin. A negative number change from baseline indicates a reduction in lesion counts(improvement).

3 secondary outcomes

Percentage of Patients With >= 1 Grade Improvement in the Investigator Global Assessment at Week 16
Time frame: Week 16
Percentage of Patients With >= 2 Grade Improvement in the Overall Disease Severity Score at Week 12
Time frame: Week 12
Median Percent Change From Baseline in Inflammatory Lesion Counts (Papules/Pustules, Nodules) at Week 16
Time frame: Baseline, Week 16

Results and safety

Results posted to the registry on 12 Sep 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tazarotene Cream 0.1%	77	60
Adapalene Gel 0.3%	88	68

Primary outcome: Median Percent Change From Baseline in the Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12

Time frame: Baseline, Week 12. Median (Full Range). Unit: Percent Change

Measure	Tazarotene Cream 0.1% n = 62	Adapalene Gel 0.3% n = 73
Value	-68.14 (-96.23 to -2.99)	-60.00 (-100.00 to 42.86)

Population analysed: Intent to Treat population included all randomized patients. The number of patients that were analyzed reflects the actual number of patients for which data were available for this outcome measure.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tazarotene Cream 0.1%	0 of 72 (0%)	10 of 72 (13.9%)	Not reported
Adapalene Gel 0.3%	0 of 85 (0%)	9 of 85 (10.6%)	Not reported

Limitations and caveats (from the sponsor): Study enrollment was terminated due to company decision before the target enrollment of 220 patients was reached.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for 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.

Medical Director study director

Allergan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tazarotene Cream 0.1% and Adapalene in people with Acne Vulgaris, run by Allergan at 1 site 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 2 inclusion and 4 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: stopped early, as of the sponsor's last update on 12 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 12 Sep 2012). 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?

Median Percent Change From Baseline in the Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12 (time frame: Baseline, 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 NCT00829049.

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 12 Sep 2012.