Acne VulgarisPhase 3NCT00392223

Efficacy And Safety Of Azithromycin SR Compared With Minocycline In Acne

A Phase 3 study testing Azithromycin microspheres and Minocycline capsules, in people with Acne Vulgaris, run by Pfizer at 17 sites in Italy.

Terminated

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

Official record

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Trial summary

The primary objective is to evaluate the clinical efficacy of azithromycin microspheres treatment in outpatients with moderate to severe inflammatory acne compared with first line treatment minocycline after 8 weeks of therapy Read more about this study

Who is it for?: Ages 16 years and older
Conditions the study is for: Acne Vulgaris
What is being tested?: Azithromycin microspheres and Minocycline capsules,
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 118 participants
Where: 17 sitesItaly
Study dates: Oct 2007to Jun 2008
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 16 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

male and female, > 16 years of age, with diagnosis of acne papulo-pustular, moderate (19-30 GAGS score) to severe (31-33 GAGS score)

Who cannot join

pregnancy, gastrointestinal and endocrinological disease, specific systemic disease, hormonal contraceptives, isotretinoin, topic drugs for acne (except detergent allowed)

Trial locations and contacts

17 sites in 1 country.

City, postcode or hospital

17 sites in 1 country

Italy17 sites

Pfizer Investigational Site
Bologna, 40121
Pfizer Investigational Site
Catania, 95124
Pfizer Investigational Site
Catanzaro, 88100
Pfizer Investigational Site
Ferrara, 44100
Pfizer Investigational Site
Genova, 16132
Pfizer Investigational Site
Germona Del Friuli, Udine, 33013
Pfizer Investigational Site
Lucca, 55100
Pfizer Investigational Site
Messina, 98100
Pfizer Investigational Site
Milan, 20100
Pfizer Investigational Site
Naples, 80131
Pfizer Investigational Site
Pisa, 56126
Pfizer Investigational Site
Pordenone, 33170
Pfizer Investigational Site
Roma, 00161
Pfizer Investigational Site
Roma, 00167
Pfizer Investigational Site
Siena, 53100
Pfizer Investigational Site
Terni, 05100
Pfizer Investigational Site
Trieste, 34100

Other trials in Italy

About this study

Official title: A Phase III, Multicenter, Randomized, Double Blind-Double Dummy Study, To Evaluate Efficacy And Safety Of Treatment With Azithromycin, Microspheres, Oral Powder For Suspension, 2 G, In One Administration A Week, For 8 Weeks, Compared With Treatment With Minocycline Capsules, 100 Mg Die For 8 Weeks, In Outpatients With Moderate To Severe Inflammatory Acne.

Read the detailed description

The study prematurely discontinued on the February 1, 2008 due to slow enrollment.It should be noted that safety concerns have not been seen in this study and have not factored into this decision.

Conditions: Acne Vulgaris
Being tested: Azithromycin microspheres, minocycline-placebo capsules, Azithromycin microspheres-placebo, Minocycline capsules,
Medical subject headings: Acne Vulgaris

What participants receive

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

Azithromycin microspheresDrug
Azithromycin microspheres, powder for oral suspension, 2 g a week, in unique administration PO, repeated weekly for 8 weeks and minocycline-placebo capsules daily for 8 weeks plus minocycline placebo
minocycline-placebo capsulesDrug
minocycline-placebo capsules daily for 8 weeks plus minocycline placebo
Azithromycin microspheres-placeboDrug
Minocycline capsules, PO, 100 mg daily for 8 weeks and Azithromycin microspheres-placebo once a week for 8 weeks plus azithromycin placebo.
Minocycline capsules,Drug
Capsules, PO, 100 mg daily for 8 weeks.

Study groups in NCT00392223
Study group	Role	What they receive
Treatment Group A	Experimental	Not described Receives: Drug: Azithromycin microspheres; Drug: minocycline-placebo capsules
Treatment Group B	Experimental	Not described Receives: Drug: Azithromycin microspheres-placebo; Drug: Minocycline capsules,

What is being measured

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

Change From Baseline to End of Treatment in Global Acne Grading System (GAGS) Score
GAGS used to assess 6 locations on face/chest/upper back; factor for each location based on surface area, distribution, density of pilosebaceous units. Locations graded separately 0 - 4 (hi). Global score factored based on summing of local scores. Change: (Global) score at observation minus (global) score at baseline.
Measured: Baseline, Week 8 End of Treatment (EOT)
Change From Baseline to End of Treatment (EOT) in Global Acne Grading System (GAGS) Score - Per Protocol Population
GAGS used to assess 6 locations on face/chest/upper back; factor for each location based on surface area, distribution, density of pilosebaceous units. Locations graded separately 0 - 4 (hi). Global score factored based on summing of local scores. Change: (Global) score at observation minus (global) score at baseline.
Measured: Baseline, Week 8 EOT

Secondary outcomes (3)

Change From Baseline in Global Acne Grading System (GAGS) Score
GAGS used to assess 6 locations on face/chest/upper back; factor for each location based on surface area, distribution, density of pilosebaceous units. Locations graded separately 0 - 4 (hi. Global score factored based on summing of local scores. Change: mean at observation minus baseline.
Measured: Baseline, Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOT
Improvement of Global Acne Grading System (GAGS) Score
Number of subjects by improvement category of GAGS score: Best improvement = reduction of GAGS score >75% (pre-post evaluation); Good improvement = reduction score > 50 - 75%; Moderate improvement : reduction score > 25 - 50%; Light improvement : reduction score > 0 - 25%; No change = reduction score = 0%; Worsening = increase score > 0 %.
Measured: Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOT
Change From Baseline in Acne Graded by Leeds Technique
Leeds Grading technique: evaluates three sites (face, back, chest) on a 0 to 10 grading scale where 0 equals to no acne and 10 equals to most severe acne.
Measured: Baseline, Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOT

Timeline

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

Oct 2007Jun 2008

First posted25 Oct 2006 (estimated)
Study startOct 2007
Primary completionJun 2008
Study completionJun 2008

Why it stopped: See Detailed Description

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.
More trials run by PfizerThe 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 118 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00392223
Sponsor's protocol ID: A0661150
Status last verified: Jan 2010
First submitted: 23 Oct 2006
Last updated: 12 Jan 2010
Results posted: Yes, on ClinicalTrials.gov

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

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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RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
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RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
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Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
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All Acne Vulgaris trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Multicenter, Randomized, Double Blind-Double Dummy Study, To Evaluate Efficacy And Safety Of Treatment With Azithromycin, Microspheres, Oral Powder For Suspension, 2 G, In One Administration A Week, For 8 Weeks, Compared With Treatment With Minocycline Capsules, 100 Mg Die For 8 Weeks, In Outpatients With Moderate To Severe Inflammatory Acne.
ClinicalTrials.gov ID: NCT00392223
Acronym / sponsor ID: A0661150
Conditions: Acne Vulgaris
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: See Detailed Description
Enrolment: 118 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Oct 2007
Primary completion: Jun 2008 (actual)
Study completion: Jun 2008 (actual)
First posted: 25 Oct 2006 (estimated)
Results: Posted 3 Aug 2009

Clinical summary

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

Detailed description

The study prematurely discontinued on the February 1, 2008 due to slow enrollment.It should be noted that safety concerns have not been seen in this study and have not factored into this decision.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 2

Arm	Type	Receives
Treatment Group A	Experimental	Drug: Azithromycin microspheres, Drug: minocycline-placebo capsules
Treatment Group B	Experimental	Drug: Azithromycin microspheres-placebo, Drug: Minocycline capsules,

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

male and female, > 16 years of age, with diagnosis of acne papulo-pustular, moderate (19-30 GAGS score) to severe (31-33 GAGS score)

Key exclusion criteria (1 listed)

pregnancy, gastrointestinal and endocrinological disease, specific systemic disease, hormonal contraceptives, isotretinoin, topic drugs for acne (except detergent allowed)

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
Azithromycin microspheresAzithromycin microspheres, powder for oral suspension, 2 g a week, in unique administration PO, repeated weekly for 8 weeks and minocycline-placebo capsules daily for 8 weeks plus minocycline placebo	Drug	Treatment Group A
minocycline-placebo capsulesminocycline-placebo capsules daily for 8 weeks plus minocycline placebo	Drug	Treatment Group A
Azithromycin microspheres-placeboMinocycline capsules, PO, 100 mg daily for 8 weeks and Azithromycin microspheres-placebo once a week for 8 weeks plus azithromycin placebo.	Drug	Treatment Group B
Minocycline capsules,Capsules, PO, 100 mg daily for 8 weeks.	Drug	Treatment Group B

Primary outcome

Change From Baseline to End of Treatment in Global Acne Grading System (GAGS) Score
Time frame: Baseline, Week 8 End of Treatment (EOT)
GAGS used to assess 6 locations on face/chest/upper back; factor for each location based on surface area, distribution, density of pilosebaceous units. Locations graded separately 0 - 4 (hi). Global score factored based on summing of local scores. Change: (Global) score at observation minus (global) score at baseline.
Change From Baseline to End of Treatment (EOT) in Global Acne Grading System (GAGS) Score - Per Protocol Population
Time frame: Baseline, Week 8 EOT
GAGS used to assess 6 locations on face/chest/upper back; factor for each location based on surface area, distribution, density of pilosebaceous units. Locations graded separately 0 - 4 (hi). Global score factored based on summing of local scores. Change: (Global) score at observation minus (global) score at baseline.

3 secondary outcomes

Change From Baseline in Global Acne Grading System (GAGS) Score
Time frame: Baseline, Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOT
Improvement of Global Acne Grading System (GAGS) Score
Time frame: Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOT
Change From Baseline in Acne Graded by Leeds Technique
Time frame: Baseline, Week 4, Week 8 End of Treatment (EOT), 8 weeks after EOT

Results and safety

Results posted to the registry on 3 Aug 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Azithromycin	58	49
Minocycline	60	47

Primary outcome: Change From Baseline to End of Treatment in Global Acne Grading System (GAGS) Score

Time frame: Baseline, Week 8 End of Treatment (EOT). Least squares mean (95% Confidence Interval). Unit: score on scale

Measure	Azithromycin n = 53	Minocycline n = 59
Value	-8.69 (-10.33 to -7.05)	-9.16 (-10.62 to -7.71)

Azithromycin vs Minocycline: Mean Difference (Final Values): -0.47 (95% CI -2.48 to 1.54)

Population analysed: Full Analysis Set, Last Observation Carried Forward (LOCF)

Primary outcome: Change From Baseline to End of Treatment (EOT) in Global Acne Grading System (GAGS) Score - Per Protocol Population

Time frame: Baseline, Week 8 EOT. Least squares mean (95% Confidence Interval). Unit: score on scale

Measure	Azithromycin n = 48	Minocycline n = 48
Value	-9.35 (-10.75 to -7.94)	-10.22 (-11.54 to -8.90)

Azithromycin vs Minocycline: Mean Difference (Final Values): -0.87 (95% CI -2.58 to 0.84)

Population analysed: Per Protocol population

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Azithromycin	0 of 58 (0%)	29 of ?	Not reported
Minocycline	0 of 60 (0%)	21 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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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RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
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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.

Pfizer CT.gov Call Center study director

Pfizer

17 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 Azithromycin microspheres and Minocycline capsules, in people with Acne Vulgaris, run by Pfizer at 17 sites in Italy.

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 1 inclusion and 1 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 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Italy. 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 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 3 Aug 2009). 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 From Baseline to End of Treatment in Global Acne Grading System (GAGS) Score (time frame: Baseline, Week 8 End of Treatment (EOT)). 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 NCT00392223.

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 Jan 2010.