AcnePhase 4NCT00837213

Comparative Efficacy and Safety of Benzoyl Peroxide Used in Combination With Clindamycin vs. Benzoyl Peroxide Used in Combination With Clindamycin and Doxycycline in the Treatment of Moderate Acne

A Phase 4 study testing Benzoyl peroxide with clindamycin and Benzoyl peroxide with clindamycin and doxycycline 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

To compare the efficacy and safety of Benzoyl peroxide used in combination with clindamycin vs. Benzoyl peroxide used in combination with clindamycin and doxycycline in the treatment of moderate acne Read more about this study

Who is it for?: Ages 16 years and older
Conditions the study is for: Acne
What is being tested?: Benzoyl peroxide with clindamycin and Benzoyl peroxide with clindamycin and doxycycline
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 33 participants
Where: 2 sitesUnited States
Study dates: Aug 2007to Aug 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 16 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Male or female subjects with acne vulgaris . Able to understand the requirements of the study and sign informed consent/HIPAA authorization forms.

Who cannot join

Known hypersensitivity to any of the components of the study drugs or used of prohibited medications or any medical condition that contraindicate the subject's participation in the clinical study

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Center for Dermatology, Cosmetic and Laser Surgery
Fremont, California, 94538
Las Vegas Skin & Cancer Clinic
Las Vegas, Nevada, 89129

Other trials in United States

About this study

To compare the efficacy and safety of Benzoyl peroxide used in combination with clindamycin vs. Benzoyl peroxide used in combination with clindamycin and doxycycline in the treatment of moderate acne

Read the detailed description

To compare the efficacy and safety of Benzoyl peroxide used in combination with clindamycin vs. Benzoyl peroxide used in combination with clindamycin and doxycycline once daily in the treatment of moderate acne

Conditions: Acne
Being tested: Benzoyl peroxide with clindamycin, Benzoyl peroxide with clindamycin and doxycycline
Keywords: 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.

Benzoyl peroxide with clindamycinDrug
Also called Acne
Benzoyl peroxide wash - Clindamycin foam
Benzoyl peroxide with clindamycin and doxycyclineDrug
Also called Acne
Benzoyl peroxide wash - Clindamycin foam - Doxycycline capsules

Study groups in NCT00837213
Study group	Role	What they receive
BPO with clindamycin foam	Active comparator	Benzoyl peroxide (BPO) wash with clindamycin foam Receives: Drug: Benzoyl peroxide with clindamycin
BPO + clindamycin foam + doxycycline	Active comparator	Benzoyl peroxide (BPO) wash with clindamycin foam and doxycycline capsules Receives: Drug: Benzoyl peroxide with clindamycin and doxycycline

What is being measured

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

Percent Change in Inflammatory Acne Lesions From Baseline to Week 16
Percent change from baseline to week 16 in inflammatory acne lesions (pustules/papules)(chest and back)
Measured: Baseline, Week 16
Percent (%) Change in Non-inflammatory Acne Lesions From Baseline to Week 16.
Percent change in Non-inflammatory acne lesions (whiteheads and blackheads)(chest and back) from baseline to week 16.
Measured: Baseline, Week 16
Percent Change in Total Acne Lesion Counts From Baseline to Week 16
Percent change from baseline to week 16 in total acne lesions (inflammatory + non-inflammatory)
Measured: Baseline, Week 16
Change in Investigator Global Assessment (IGA)
Change in Investigator Global Assessment (IGA) Average values chest and back.
IGA scale:
0 - Clear
0.5 - Clear/almost clear
1. Almost Clear 1.5- Almost Clear/Mild
2. Mild 2.5- Mild/Moderate
3. Moderate
3.5- Moderate/Severe
Measured: Baseline, Weeks 4, 8,12, and 16

Secondary outcomes (4)

Percent (%) Change in Inflammatory Lesion Counts (Chest and Back) From Baseline to Week 12
Percent change in inflammatory lesion counts (chest and back)from Baseline to Week 12
Measured: Baseline, Week 12
Percent Change in Non-inflammatory Lesions (Chest and Back) From Baseline to Week 12
Percent change in non-inflammatory lesions (chest and back) from baseline to Week 12
Measured: Baseline, Week 12
Percent Change in Total Lesions (Chest and Back) From Baseline to Week 12
Percent change in total lesions (chest and back) from baseline to Week 12
Measured: Week 12
Percentage of Particpants With IGA Score at Week 16
Investigator Global Assessment (IGA) at Week 16 based on the Investigator Global Assessment
IGA:
0 - Clear
0.5 - Clear/almost clear
1. Almost Clear 1.5- Almost Clear/Mild
2. Mild 2.5- Mild/Moderate
3. Moderate
3.5- Moderate/Severe
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.

Aug 2007Aug 2008

First posted5 Feb 2009 (estimated)
Study startAug 2007
Primary completionAug 2008
Study completionAug 2008

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 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: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00837213
Sponsor's protocol ID: EVF0701
Status last verified: May 2017
First submitted: 4 Feb 2009
Last updated: 25 May 2017
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 trials

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 Efficacy and Safety of Benzoyl Peroxide Used in Combination With Clindamycin vs. Benzoyl Peroxide Used in Combination With Clindamycin and Doxycycline in the Treatment of Moderate Acne
ClinicalTrials.gov ID: NCT00837213
Acronym / sponsor ID: EVF0701
Conditions: Acne
Keywords: Acne
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: Stiefel, a GSK CompanyIndustry (pharma, biotech, devices)
Collaborators: GlaxoSmithKline
Study start: Aug 2007
Primary completion: Aug 2008 (actual)
Study completion: Aug 2008 (actual)
First posted: 5 Feb 2009 (estimated)
Results: Posted 31 Aug 2010

Clinical summary

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

To compare the efficacy and safety of Benzoyl peroxide used in combination with clindamycin vs. Benzoyl peroxide used in combination with clindamycin and doxycycline in the treatment of moderate acne

Detailed description

Study design

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

Arm	Type	Receives
BPO with clindamycin foam	Active comparator	Drug: Benzoyl peroxide with clindamycinBenzoyl peroxide (BPO) wash with clindamycin foam
BPO + clindamycin foam + doxycycline	Active comparator	Drug: Benzoyl peroxide with clindamycin and doxycyclineBenzoyl peroxide (BPO) wash with clindamycin foam and doxycycline 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 or female subjects with acne vulgaris . Able to understand the requirements of the study and sign informed consent/HIPAA authorization forms.

Key exclusion criteria (1 listed)

Known hypersensitivity to any of the components of the study drugs or used of prohibited medications or any medical condition that contraindicate the subject's participation in the clinical study

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
Benzoyl peroxide with clindamycinAlso: AcneBenzoyl peroxide wash - Clindamycin foam	Drug	BPO with clindamycin foam
Benzoyl peroxide with clindamycin and doxycyclineAlso: AcneBenzoyl peroxide wash - Clindamycin foam - Doxycycline capsules	Drug	BPO + clindamycin foam + doxycycline

Primary outcome

Percent Change in Inflammatory Acne Lesions From Baseline to Week 16
Time frame: Baseline, Week 16
Percent change from baseline to week 16 in inflammatory acne lesions (pustules/papules)(chest and back)
Percent (%) Change in Non-inflammatory Acne Lesions From Baseline to Week 16.
Time frame: Baseline, Week 16
Percent change in Non-inflammatory acne lesions (whiteheads and blackheads)(chest and back) from baseline to week 16.
Percent Change in Total Acne Lesion Counts From Baseline to Week 16
Time frame: Baseline, Week 16
Percent change from baseline to week 16 in total acne lesions (inflammatory + non-inflammatory)
Change in Investigator Global Assessment (IGA)
Time frame: Baseline, Weeks 4, 8,12, and 16
Change in Investigator Global Assessment (IGA) Average values chest and back. IGA scale: 0 - Clear 0.5 - Clear/almost clear 1. Almost Clear 1.5- Almost Clear/Mild 2. Mild 2.5- Mild/Moderate 3. Moderate 3.5- Moderate/Severe

4 secondary outcomes

Percent (%) Change in Inflammatory Lesion Counts (Chest and Back) From Baseline to Week 12
Time frame: Baseline, Week 12
Percent Change in Non-inflammatory Lesions (Chest and Back) From Baseline to Week 12
Time frame: Baseline, Week 12
Percent Change in Total Lesions (Chest and Back) From Baseline to Week 12
Time frame: Week 12
Percentage of Particpants With IGA Score at Week 16
Time frame: Baseline, Week 16

Results and safety

Results posted to the registry on 31 Aug 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
Benzoyl Peroxide Wash -Clindamycin Foam	16	10
Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules	17	12

Primary outcome: Percent Change in Inflammatory Acne Lesions From Baseline to Week 16

Time frame: Baseline, Week 16. Mean (Standard Deviation). Unit: Percent change

Measure	Benzoyl Peroxide Wash -Clindamycin Foam n = 16	Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules n = 17
Value	-52.70 (26.83)	-48.84 (40.37)

Population analysed: ITT

Primary outcome: Percent (%) Change in Non-inflammatory Acne Lesions From Baseline to Week 16.

Time frame: Baseline, Week 16. Mean (Standard Deviation). Unit: Percent Change

Measure	Benzoyl Peroxide Wash -Clindamycin Foam n = 16	Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules n = 17
Value	-25.27 (45.64)	-44.69 (43.72)

Population analysed: ITT

Primary outcome: Percent Change in Total Acne Lesion Counts From Baseline to Week 16

Time frame: Baseline, Week 16. Mean (Standard Deviation). Unit: Percent Change

Measure	Benzoyl Peroxide Wash -Clindamycin Foam n = 16	Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules n = 17
Value	-38.49 (33.06)	-46.11 (39.74)

Population analysed: ITT

Primary outcome: Change in Investigator Global Assessment (IGA)

Time frame: Baseline, Weeks 4, 8,12, and 16. Mean (Standard Deviation). Unit: Units on a scale

Measure	Benzoyl Peroxide Wash -Clindamycin Foam n = 16	Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules n = 17
Change from Baseline to Week 4	-0.42 (0.57)	-0.61 (0.59)
Change from Baseline to Week 8	-0.55 (0.88)	-0.85 (0.72)
Change from Baseline to Week 12	-1 (1.07)	-1.09 (0.8)
Change from Baseline to Week 16	-0.9 (0.94)	-1.25 (0.97)

Population analysed: ITT

4 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
Benzoyl Peroxide Wash -Clindamycin Foam	0 of 13 (0%)	4 of 13 (30.8%)	Not reported
Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules	0 of 14 (0%)	4 of 14 (28.6%)	Not reported

Limitations and caveats (from the sponsor): Small sample size did not provide adequate power. Even with the limited sample size, total lesion counts provides a more reliable view of the study data due to the greater number of lesions to work with.

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.

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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 Benzoyl peroxide with clindamycin and Benzoyl peroxide with clindamycin and doxycycline 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 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: 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 31 Aug 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?

Percent Change in Inflammatory Acne Lesions From Baseline to Week 16 (time frame: Baseline, Week 16). The study lists 4 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 NCT00837213.

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.