AcnePhase 4NCT00841776

Comparative Antimicrobial Efficacy of Two Topical Acne Therapies for the Treatment of Facial Acne

A Phase 4 study testing Duac and Ziana gel in people with Acne, run by Stiefel, a GSK Company at 2 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

The purpose of the study is to determine the development of microbial resistance when using one of two topical acne therapies for the treatment of facial acne vulgaris. Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: Acne
What is being tested?: Duac and Ziana gel
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 54 participants
Where: 2 sitesUnited States
Study dates: Aug 2007to Jan 2009
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

Outpatient at least 12 years of age. Female subjects of childbearing potential must have a negative urine pregnancy test result at baseline and practice a reliable method of contraception throughout the study.
Mild to moderate facial acne vulgaris
Able to understand the requirements of the study and sign informed consent/HIPAA authorization forms. Subjects under the legal age of consent in the state where the study is conducted must also have the written, informed consent of a parent or legal guardian.

Who cannot join

Female subjects who are pregnant (positive urine pregnancy test), breast feeding or who are of childbearing potential and not practicing a reliable method of birth control
Allergy or sensitivity to any component of the test medication
Known hypersensitivity to to any component of the investigational formulations
Known history of enteritis (regional enteritis, ulcerative colitis, pseudomembranous colitis, or antibiotic-associated colitis
Beards or sideburns
Skin disease/disorder that might interfere with the diagnosis or evaluation of acne vulgaris
Evidence of recent alcohol or drug abuse
Participation in an investigational drug study within 30 days of the baseline visit

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Dermatology Specialists, PSC
Louisville, Kentucky, 40202
Skin We Care Dermatology
Mason, Ohio, 45040

Other trials in United States

About this study

Official title: Comparative Antimicrobial Efficacy of Two Topical Acne Therapies for the Treatment of Moderate to Moderately Severe Facial Acne Vulgaris

The purpose of the study is to determine the development of microbial resistance when using one of two topical acne therapies for the treatment of facial acne vulgaris.

Read the detailed description

To investigate the development of microbial resistance when using one of two topical acne therapies for the treatment of moderate to moderately severe facial acne vulgaris. Clinical efficacy and tolerability will be assessed.

Conditions: Acne
Being tested: Duac, Ziana gel
Keywords: Acne Vulgaris, Acne
Medical subject headings: Acne Vulgaris

What participants receive

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

DuacDrug
Clindamycon and benzoyl peroxide topical gel once a day for 12 weeks
Ziana gelDrug
Clindamycin and tretinoin gel once a day for 12 weeks.

Study groups in NCT00841776
Study group	Role	What they receive
Duac gel	Active comparator	Clindamycin and benzoyl peroxide gel Receives: Drug: Duac
Ziana gel	Active comparator	Clindamycin and tretinoin gel Receives: Drug: Ziana gel

What is being measured

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

Median Change in Total Propionibacterium Acne (P.Acne) Counts
Median change in total colony forming units of propionibacterium acne (P.acne) will be counted.
Measured: Baseline, Weeks 2, 4, 8, 12, & 16

Secondary outcomes (5)

Median Change in Clindamycin Resistant P. Acne.
Median change in total colony forming units of clindamycin resistant p. acne.
Measured: Baseline, Weeks 2, 4, 8, 12, 16
Median Change in Erythromycin-resistant P. Acne Counts
Total colony forming units of erythromycin-resistant p. acnes.
Measured: Baseline, Weeks 2, 4, 8, 12, and 16
Median Change in Total Acne Lesions
Median Change in Total Acne Lesions
Measured: Baseline, Weeks 2, 4, 8, 12, and 16
Median Change in Inflammatory Acne Lesion Counts
Median Change in Inflammatory Acne Lesion Counts
Measured: Baseline, Weeks 2, 4, 8, 12, and 16
Median Change in Noninflammaotry Acne Counts
Median Change in Noninflammaotry Acne Counts
Measured: Baseline, Weeks 2, 4, 8, 12, and 16

Timeline

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

Aug 2007Jan 2009

First posted11 Feb 2009 (estimated)
Study startAug 2007
Primary completionNov 2008
Study completionJan 2009

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for AcneStudies 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: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00841776
Sponsor's protocol ID: DTG0703
Status last verified: May 2017
First submitted: 10 Feb 2009
Last updated: 25 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Jackson JM, Fu JJ, Almekinder JL. A randomized, investigator-blinded trial to assess the antimicrobial efficacy of a benzoyl peroxide 5%/ clindamycin phosphate 1% gel compared with a clindamycin phosphate 1.2%/tretinoin 0.025% gel in the topical treatment of acne vulgaris. J Drugs Dermatol. 2010 Feb;9(2):131-6.
PubMed 20214175

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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Study at a glance

From the registry record, last updated by the sponsor on 25 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparative Antimicrobial Efficacy of Two Topical Acne Therapies for the Treatment of Moderate to Moderately Severe Facial Acne Vulgaris
ClinicalTrials.gov ID: NCT00841776
Acronym / sponsor ID: DTG0703
Conditions: Acne
Keywords: Acne Vulgaris, Acne
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: Stiefel, a GSK CompanyIndustry (pharma, biotech, devices)
Collaborators: GlaxoSmithKline
Study start: Aug 2007
Primary completion: Nov 2008 (actual)
Study completion: Jan 2009 (actual)
First posted: 11 Feb 2009 (estimated)
Results: Posted 23 Jul 2010

Clinical summary

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

The purpose of the study is to determine the development of microbial resistance when using one of two topical acne therapies for the treatment of facial acne vulgaris.

Detailed description

Study design

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

Arm	Type	Receives
Duac gel	Active comparator	Drug: DuacClindamycin and benzoyl peroxide gel
Ziana gel	Active comparator	Drug: Ziana gelClindamycin and tretinoin gel

Who may qualify

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

Key inclusion criteria (3 listed)

Outpatient at least 12 years of age. Female subjects of childbearing potential must have a negative urine pregnancy test result at baseline and practice a reliable method of contraception throughout the study.
Mild to moderate facial acne vulgaris
Able to understand the requirements of the study and sign informed consent/HIPAA authorization forms. Subjects under the legal age of consent in the state where the study is conducted must also have the written, informed consent of a parent or legal guardian.

Key exclusion criteria (8 listed)

Female subjects who are pregnant (positive urine pregnancy test), breast feeding or who are of childbearing potential and not practicing a reliable method of birth control
Allergy or sensitivity to any component of the test medication
Known hypersensitivity to to any component of the investigational formulations
Known history of enteritis (regional enteritis, ulcerative colitis, pseudomembranous colitis, or antibiotic-associated colitis
Beards or sideburns

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
DuacClindamycon and benzoyl peroxide topical gel once a day for 12 weeks	Drug	Duac gel
Ziana gelClindamycin and tretinoin gel once a day for 12 weeks.	Drug	Ziana gel

Primary outcome

Median Change in Total Propionibacterium Acne (P.Acne) Counts
Time frame: Baseline, Weeks 2, 4, 8, 12, & 16
Median change in total colony forming units of propionibacterium acne (P.acne) will be counted.

5 secondary outcomes

Median Change in Clindamycin Resistant P. Acne.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16
Median Change in Erythromycin-resistant P. Acne Counts
Time frame: Baseline, Weeks 2, 4, 8, 12, and 16
Median Change in Total Acne Lesions
Time frame: Baseline, Weeks 2, 4, 8, 12, and 16
Median Change in Inflammatory Acne Lesion Counts
Time frame: Baseline, Weeks 2, 4, 8, 12, and 16
Median Change in Noninflammaotry Acne Counts
Time frame: Baseline, Weeks 2, 4, 8, 12, and 16

Results and safety

Results posted to the registry on 23 Jul 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Duac	27	25
Ziana	27	24

Primary outcome: Median Change in Total Propionibacterium Acne (P.Acne) Counts

Time frame: Baseline, Weeks 2, 4, 8, 12, & 16. Median (Inter-Quartile Range). Unit: P. acne counts

Measure	Duac n = 27	Ziana n = 27
Change from Baseline to Week 2	-1.26 (1.44)	-0.08 (0.82)
Change from Baseline to Week 4	-1.58 (1.49)	-0.67 (1.18)
Change from Baseline to Week 8	-1.65 (1.50)	-0.32 (1.04)
Change from Baseline to Week 12	-1.82 (1.60)	-0.59 (0.99)
Change from Baseline to Week 16	-2.48 (1.77)	-0.57 (0.83)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 16 weeks. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Duac	0 of 27 (0%)	5 of 27 (18.5%)	Not reported
Ziana	0 of 27 (0%)	5 of 27 (18.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 20214175Jackson JM, Fu JJ, Almekinder JL. A randomized, investigator-blinded trial to assess the antimicrobial efficacy of a benzoyl peroxide 5%/ clindamycin phosphate 1% gel compared with a clindamycin phosphate 1.2%/tretinoin 0.025% gel in the topical treatment of acne vulgaris. J Drugs Dermatol. 2010 Feb;9(2):131-6.

Related trials for Acne

Not yet recruitingPhase 3
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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.

GSK Clinical Trials study director

GlaxoSmithKline

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Duac and Ziana gel in people with Acne, run by Stiefel, a GSK Company at 2 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 8 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 25 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 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 23 Jul 2010). 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 Change in Total Propionibacterium Acne (P.Acne) Counts (time frame: Baseline, Weeks 2, 4, 8, 12, & 16). 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 NCT00841776, which also lists 1 linked publication.

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 25 May 2017.