Acne VulgarisPhase 2NCT00713609

Safety and Efficacy Study of Clindamycin/Benzoyl Peroxide/Tazarotene Cream in Subjects With Acne

A Phase 2 study testing Benzoyl peroxide gel, Clindamycin gel and Tazarotene cream in people with Acne Vulgaris, run by Stiefel, a GSK Company at 16 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

Benzoyl peroxide, clindamycin and tazarotene are known to be effective treatment alternative for acne vulgaris. The purpose of this study is to assess the safety and efficacy of a combination product including these actives for the treatment of acne vulgaris. Read more about this study

Who is it for?: Ages 12 to 45 years
Conditions the study is for: Acne Vulgaris
What is being tested?: Benzoyl peroxide gel, Clindamycin gel and Tazarotene cream
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 591 participants
Where: 16 sitesUnited States
Study dates: Jun 2008to Mar 2009
Phase: Phase 2
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 45 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Inclusion Criteria: Subjects must be males or females 12 to 45 years of age.
Subjects must have acne on their face.
Female subjects of childbearing potential must have a negative pregnancy test. If sexually active, one medically acceptable forms of contraception must be practiced from baseline to the last study visit.
Subjects must have the ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.
Subjects must be capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements).
Subjects must be able to complete the study and to comply with study instructions.

Who cannot join

Subjects who are pregnant, trying to become pregnant, or breast-feeding.
Subjects with conditions that may influence the safety and or efficacy assessments of the study including, but not limited to: regional enteritis or inflammatory bowel disease, lupus, dermatomyositis, rosacea, seborrheic dermatitis, beard folliculitis, or perioral dermatitis, subject who are immunocompromised or have had any major illness within 30 days before the screening examination
History of known or suspected intolerance including any known hypersensitivity or previous allergic reaction to any of the ingredients of the study products
Subjects who have used topical antibiotics or topical steroids on the face, facial procedures, or any investigational therapy within the past 4 weeks or systemic retinoids within the past 6 months.
Subjects who have any other disease or condition, or are using any medication, that in the judgment of the investigator would put the subject at unacceptable risk for participation in the study.
Other exclusion criteria may apply.

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

United States16 sites

Boulder Medical Center, P.C.
Boulder, Colorado, 80304
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27599
Dermatology Associates Research
Coral Gables, Florida, 33134
Dermatology Treatment & Research Center
Dallas, Texas, 75230
Center for Dermatology Cosmetic and Laser Surgery
Fremont, California, 94538
Rivergate Dermatology & Skin Care Center
Goodlettsville, Tennessee, 37072
MS Hershey Medical Center
Hershey, Pennsylvania, 17033
Dermatology Consulting Services
High Point, North Carolina, 27262
Suzanne Bruce and Associates, PA
Houston, Texas, 77056
The Skin Wellness Center, PC
Knoxville, Tennessee, 37922
Dermatology Research of Arkansas
Little Rock, Arkansas, 72205
Callender Center for Clinical Research
Mitchellville, Maryland, 20721
MedaPhase, Inc.
Newnan, Georgia, 30263
Center for Dermatology and Laser Surgery
Sacramento, California, 95819
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, 78229
Grekin Skin Institute
Warren, Michigan, 48088

Other trials in United States

About this study

Official title: A Multi-center, Randomized, Double-blind, Vehicle-Controlled, Phase 2 Study of the Safety and Efficacy of Benzoyl Peroxide/Clindamycin Gel and Tazarotene Cream When Used in Combination in the Treatment of Acne Vulgaris

You may be suitable to take part in this study because you have acne vulgaris on your face. Acne vulgaris usually affects the face, but it can also affect the skin on the chest, arms, legs, and back.

Read the detailed description

The study subjects must have acne vulgaris and will apply study drug to their face for 12 weeks.

Study visits will occur at baseline (day 1) and at weeks 2, 4, 8, and 12. Subjects will be assessed at every visit to determine how the study drug is working. Safety will be assessed by evaluation of adverse events (AEs), vital signs, physical examinations, and withdrawals from the study.

Conditions: Acne Vulgaris
Being tested: Benzoyl peroxide gel, Clindamycin gel, Tazarotene cream, Vehicle gel, Vehicle cream
Keywords: Acne, Acne Vulgaris, Pimples
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 gelDrug
5% benzoyl peroxide in a gel applied topically once a day
Clindamycin gelDrug
1% clindamycin phosphate applied topically once a day
Tazarotene creamDrug
0.1 % tazarotene in a cream applied topically once a day
Vehicle gelDrug
Vehicle gel is an identical gel without the active ingredients
Vehicle creamDrug
Vehicle cream is an identical cream without the active ingredients

Study groups in NCT00713609
Study group	Role	What they receive
1	Experimental	Benzoyl peroxide/clindamycin gel + tazarotene cream Receives: Drug: Benzoyl peroxide gel; Drug: Clindamycin gel; Drug: Tazarotene cream
2	Active comparator	Benzoyl peroxide/clindamycin gel + vehicle cream Receives: Drug: Benzoyl peroxide gel; Drug: Clindamycin gel; Drug: Vehicle cream
3	Active comparator	Benzoyl peroxide gel + tazarotene cream Receives: Drug: Benzoyl peroxide gel; Drug: Tazarotene cream
4	Active comparator	Clindamycin gel + tazarotene cream Receives: Drug: Clindamycin gel; Drug: Tazarotene cream
5	Active comparator	Vehicle gel+ tazarotene cream Receives: Drug: Tazarotene cream; Drug: Vehicle gel
6	Placebo comparator	Vehicle gel + vehicle cream Receives: Drug: Vehicle gel; Drug: Vehicle cream

What is being measured

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

Absolute Change in Lesion Counts (Total, Inflammatory, and Non-inflammatory) From Baseline to Week 12
The investigator or designee took count of inflammatory lesions (papules, pustules, nodules and cysts [only post-Baseline]) (ILC), noninflammatory lesions (open and closed comedones) (NILC) and total lesions (TLC) at Baseline, Weeks 2, 4, 8, and 12. Lesion counts were confined to the face. Each of 3 lesion counts (total, inflammatory and non-inflammatory) was analyzed using an analysis of covariance (ANCOVA) model with terms for treatment, center, Baseline value and treatment-by-center interaction. If the interaction was not significant at 0.1 level, this interaction was excluded in ANCOVA model. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified timepoints were analyzed (represented by n=X in the category titles).
Measured: Baseline and up to Week 12
Proportion of Participants With a Minimum 2-grade Improvement in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12
An ISGA was obtained at Baseline and at Weeks 2, 4, 8, and 12. The scores range from 0-5 (0=clear skin with no inflammatory or non-inflammatory lesions; 5=very severe with many non-inflammatory and inflammatory lesions and more than a few nodular lesions (may have cystic lesions). The higher score indicates more severe. The area considered for the ISGA was confined to the face. When possible, the same efficacy assessor performed all ISGA assessments on the same participant at all visits. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified time points were analyzed.
Measured: Baseline and up to Week 12

Secondary outcomes (2)

Percent Change From Baseline to Week 12 in Each of 3 Lesion Counts (Total, Inflammatory, and Non-inflammatory)
The investigator or designee took count of inflammatory lesions (papules, pustules, nodules and cysts) (ILC), noninflammatory lesions (open and closed comedones) (NILC) and total lesions (TLC) at Baseline, Weeks 2, 4, 8, and 12. Lesion counts were confined to the face. Each of 3 lesion counts (total, inflammatory and non-inflammatory) was analyzed using an analysis of covariance (ANCOVA) model with terms for treatment, center, Baseline value and treatment-by-center interaction. If the interaction was not significant at 0.1 level, this interaction was excluded in ANCOVA model. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified timepoints were analyzed (represented by n=X in the category titles).
Measured: Baseline and up to Week 12
Proportion of Participants With an ISGA Score of 0 or 1 at Week 12
An ISGA was obtained at Baseline and at Weeks 2, 4, 8, and 12. The scores range from 0-5 (0=clear skin with no inflammatory or non-inflammatory lesions; 5=very severe with many non-inflammatory and inflammatory lesions and more than a few nodular lesions (may have cystic lesions). The higher score indicates more severe. The area considered for the ISGA was confined to the face. When possible, the same efficacy assessor performed all ISGA assessments on the same participant at all visits. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified time points were analyzed.
Measured: Week 12

Timeline

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

Jun 2008Mar 2009

First posted11 Jul 2008 (estimated)
Study startJun 2008
Primary completionMar 2009
Study completionMar 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.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 591 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00713609
Sponsor's protocol ID: 114570
Status last verified: Jan 2017
First submitted: 7 Jul 2008
Last updated: 6 Mar 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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RecruitingPhase 4
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All Acne Vulgaris trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-center, Randomized, Double-blind, Vehicle-Controlled, Phase 2 Study of the Safety and Efficacy of Benzoyl Peroxide/Clindamycin Gel and Tazarotene Cream When Used in Combination in the Treatment of Acne Vulgaris
ClinicalTrials.gov ID: NCT00713609
Acronym / sponsor ID: 114570
Conditions: Acne Vulgaris
Keywords: Acne, Acne Vulgaris, Pimples
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 591 participants (actual)
Lead sponsor: Stiefel, a GSK CompanyIndustry (pharma, biotech, devices)
Collaborators: GlaxoSmithKline
Study start: Jun 2008
Primary completion: Mar 2009 (actual)
Study completion: Mar 2009 (actual)
First posted: 11 Jul 2008 (estimated)
Results: Posted 6 Mar 2017

Clinical summary

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

You may be suitable to take part in this study because you have acne vulgaris on your face. Acne vulgaris usually affects the face, but it can also affect the skin on the chest, arms, legs, and back.

Detailed description

The study subjects must have acne vulgaris and will apply study drug to their face for 12 weeks.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
1	Experimental	Drug: Benzoyl peroxide gel, Drug: Clindamycin gel, Drug: Tazarotene creamBenzoyl peroxide/clindamycin gel + tazarotene cream
2	Active comparator	Drug: Benzoyl peroxide gel, Drug: Clindamycin gel, Drug: Vehicle creamBenzoyl peroxide/clindamycin gel + vehicle cream
3	Active comparator	Drug: Benzoyl peroxide gel, Drug: Tazarotene creamBenzoyl peroxide gel + tazarotene cream
4	Active comparator	Drug: Clindamycin gel, Drug: Tazarotene creamClindamycin gel + tazarotene cream
5	Active comparator	Drug: Tazarotene cream, Drug: Vehicle gelVehicle gel+ tazarotene cream
6	Placebo comparator	Drug: Vehicle gel, Drug: Vehicle creamVehicle gel + vehicle cream

Who may qualify

Ages: 12 to 45 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (6 listed)

Inclusion Criteria: Subjects must be males or females 12 to 45 years of age.
Subjects must have acne on their face.
Female subjects of childbearing potential must have a negative pregnancy test. If sexually active, one medically acceptable forms of contraception must be practiced from baseline to the last study visit.
Subjects must have the ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.
Subjects must be capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements).

Key exclusion criteria (6 listed)

Subjects who are pregnant, trying to become pregnant, or breast-feeding.
Subjects with conditions that may influence the safety and or efficacy assessments of the study including, but not limited to: regional enteritis or inflammatory bowel disease, lupus, dermatomyositis, rosacea, seborrheic dermatitis, beard folliculitis, or perioral dermatitis, subject who are immunocompromised or have had any major illness within 30 days before the screening examination
History of known or suspected intolerance including any known hypersensitivity or previous allergic reaction to any of the ingredients of the study products
Subjects who have used topical antibiotics or topical steroids on the face, facial procedures, or any investigational therapy within the past 4 weeks or systemic retinoids within the past 6 months.
Subjects who have any other disease or condition, or are using any medication, that in the judgment of the investigator would put the subject at unacceptable risk for participation in the 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 gel5% benzoyl peroxide in a gel applied topically once a day	Drug	1, 2, 3
Clindamycin gel1% clindamycin phosphate applied topically once a day	Drug	1, 2, 4
Tazarotene cream0.1 % tazarotene in a cream applied topically once a day	Drug	1, 3, 4, 5
Vehicle gelVehicle gel is an identical gel without the active ingredients	Drug	5, 6
Vehicle creamVehicle cream is an identical cream without the active ingredients	Drug	2, 6

Primary outcome

Absolute Change in Lesion Counts (Total, Inflammatory, and Non-inflammatory) From Baseline to Week 12
Time frame: Baseline and up to Week 12
The investigator or designee took count of inflammatory lesions (papules, pustules, nodules and cysts [only post-Baseline]) (ILC), noninflammatory lesions (open and closed comedones) (NILC) and total lesions (TLC) at Baseline, Weeks 2, 4, 8, and 12. Lesion counts were confined to the face. Each of 3 lesion counts (total, inflammatory and non-inflammatory) was analyzed using an analysis of covariance (ANCOVA) model with terms for treatment, center, Baseline value and treatment-by-center interaction. If the interaction was not significant at 0.1 level, this interaction was excluded in ANCOVA model. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified timepoints were analyzed (represented by n=X in the category titles).
Proportion of Participants With a Minimum 2-grade Improvement in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12
Time frame: Baseline and up to Week 12
An ISGA was obtained at Baseline and at Weeks 2, 4, 8, and 12. The scores range from 0-5 (0=clear skin with no inflammatory or non-inflammatory lesions; 5=very severe with many non-inflammatory and inflammatory lesions and more than a few nodular lesions (may have cystic lesions). The higher score indicates more severe. The area considered for the ISGA was confined to the face. When possible, the same efficacy assessor performed all ISGA assessments on the same participant at all visits. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified time points were analyzed.

2 secondary outcomes

Percent Change From Baseline to Week 12 in Each of 3 Lesion Counts (Total, Inflammatory, and Non-inflammatory)
Time frame: Baseline and up to Week 12
Proportion of Participants With an ISGA Score of 0 or 1 at Week 12
Time frame: Week 12

Results and safety

Results posted to the registry on 6 Mar 2017, 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/Clindamycin + Tazarotene	106	85
Benzoyl Peroxide/Clindamycin + Vehicle Cream	105	90
Benzoyl Peroxide Gel + Tazarotene	107	92
Clindamycin Gel + Tazarotene	108	99
Vehicle Gel + Tazarotene	106	87
Vehicle Gel + Vehicle Cream	55	47

Primary outcome: Absolute Change in Lesion Counts (Total, Inflammatory, and Non-inflammatory) From Baseline to Week 12

Time frame: Baseline and up to Week 12. Mean (Standard Deviation). Unit: Lesion count

Measure	Benzoyl Peroxide/Clindamycin + Tazarotene n = 106	Benzoyl Peroxide/Clindamycin + Vehicle Cream n = 105	Benzoyl Peroxide Gel + Tazarotene n = 107	Clindamycin Gel + Tazarotene n = 107	Vehicle Gel + Tazarotene n = 106	Vehicle Gel + Vehicle Cream n = 55
ILC, n=101, 103, 105, 105, 104, 52	-16.8 (14.35)	-18.1 (14.45)	-18.9 (12.84)	-18.8 (11.49)	-14.5 (12.76)	-8.96 (12.63)
NILC, n=101, 103, 105, 105, 104, 52	-33.0 (23.94)	-24.9 (33.41)	-37.1 (29.70)	-37.5 (29.51)	-33.0 (25.89)	-18.9 (28.41)
TLC, n=101, 103, 105, 105, 104, 52	-49.8 (31.78)	-43.0 (42.24)	-56.0 (34.99)	-56.3 (35.42)	-47.6 (33.32)	-27.8 (35.06)

Benzoyl Peroxide/Clindamycin + Tazarotene vs Benzoyl Peroxide/Clindamycin + Vehicle Cream: p = 0.692, ANCOVA
Benzoyl Peroxide/Clindamycin + Tazarotene vs Benzoyl Peroxide Gel + Tazarotene: p = 0.467, ANCOVA
Benzoyl Peroxide/Clindamycin + Tazarotene vs Clindamycin Gel + Tazarotene: p = 0.281, ANCOVA

Population analysed: Intent-to-treat (ITT) Analysis Set: all randomized participants who received study product and reached Week 12.

Primary outcome: Proportion of Participants With a Minimum 2-grade Improvement in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12

Time frame: Baseline and up to Week 12. Number. Unit: Percentage of participants

Measure	Benzoyl Peroxide/Clindamycin + Tazarotene n = 106	Benzoyl Peroxide/Clindamycin + Vehicle Cream n = 105	Benzoyl Peroxide Gel + Tazarotene n = 107	Clindamycin Gel + Tazarotene n = 108	Vehicle Gel + Tazarotene n = 106	Vehicle Gel + Vehicle Cream n = 55
Value	22	22	31	36	20	5

Benzoyl Peroxide/Clindamycin + Tazarotene vs Benzoyl Peroxide/Clindamycin + Vehicle Cream: p = 0.922, Cochran-Mantel-Haenszel
Benzoyl Peroxide/Clindamycin + Tazarotene vs Benzoyl Peroxide Gel + Tazarotene: p = 0.132, Cochran-Mantel-Haenszel
Benzoyl Peroxide/Clindamycin + Tazarotene vs Clindamycin Gel + Tazarotene: p = 0.020, Cochran-Mantel-Haenszel

Population analysed: ITT Analysis Set

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 up to Day 89.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Benzoyl Peroxide/Clindamycin + Tazarotene	0 of 106 (0%)	25 of 106 (23.6%)	Not reported
Benzoyl Peroxide/Clindamycin + Vehicle Cream	0 of 105 (0%)	22 of 105 (21%)	Not reported
Benzoyl Peroxide Gel + Tazarotene	0 of 107 (0%)	24 of 107 (22.4%)	Not reported
Clindamycin Gel + Tazarotene	0 of 108 (0%)	18 of 108 (16.7%)	Not reported
Vehicle Gel + Tazarotene	0 of 106 (0%)	29 of 106 (27.4%)	Not reported
Vehicle Gel + Vehicle Cream	0 of 55 (0%)	12 of 55 (21.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 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

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Benzoyl peroxide gel, Clindamycin gel and Tazarotene cream in people with Acne Vulgaris, run by Stiefel, a GSK Company at 16 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 6 inclusion and 6 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 6 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 6 Mar 2017). 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?

Absolute Change in Lesion Counts (Total, Inflammatory, and Non-inflammatory) From Baseline to Week 12 (time frame: Baseline and up to 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 NCT00713609.

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 6 Mar 2017.