Acne VulgarisPhase 3NCT00776919

Trial of Clindamycin / Benzoyl Peroxide Gel in Subjects With Acne

A Phase 3 study testing clindamycin / benzoyl peroxide gel, clindamycin gel and BPO gel in people with Acne Vulgaris, run by Stiefel, a GSK Company at 24 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is a Randomized, Double-Blind, Controlled Study to evaluate the Safety and Efficacy of a clindamycin / benzoyl peroxide gel in Subjects with 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?: clindamycin / benzoyl peroxide gel, clindamycin gel and BPO gel
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,315 participants
Where: 24 sitesin 3 countries
Study dates: Oct 2008to Sep 2009
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 12 to 45 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Be 12 to 45 years of age, inclusive, and in good general health.
Clinical diagnosis of acne vulgaris
Females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product.
Have the ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.
Have the ability to understand and sign a written informed consent form, which must be completed prior to study specific tasks being performed. Subjects under the legal age of consent in the state/province/country where the study is conducted must provide assent and have the written informed consent of a parent or guardian.

Who cannot join

Are pregnant or breast-feeding.
Have a history or presence of other conditions that may increase the risk of the subject participating in the study and/or affect the evaluated outcomes.
Used topical antibiotics on the face or used systemic antibiotics within the past 2 weeks.
Used topical corticosteroids on the face or systemic corticosteroids within the past 4 weeks. Use of inhaled, intra-articular, or intra-lesional steroids other than for facial acne is acceptable.
Used systemic retinoids within the past 6 months or topical retinoids within the past 6 weeks.
Received treatment with estrogens (including oral, implanted, injected and topical contraceptives), androgens, or anti-androgenic agents for 12 weeks or less immediately prior to starting study product. Subjects who have been treated with estrogens, as described above, androgens, or anti-androgenic agents for more than 12 consecutive weeks prior to start of study product are allowed to enroll as long as they do not expect to change dose, drug, or discontinue use during the study.

Show all 11Show fewer

Used topical anti-acne medications (eg, BPO, azelaic acid, resorcinol, salicylates, etc.) within the past 2 weeks.
Used abradents or facial procedures, within the past 2 weeks.
Use medications that may exacerbate acne.
Have a known hypersensitivity or have had previous allergic reaction to any of the active components, lincomycin, or excipients of the study product.
Used any investigational therapy within the past 4 weeks, or currently participating in another clinical study.

Trial locations and contacts

24 sites in 3 countries.

Country

City, postcode or hospital

24 sites in 3 countries

United States16 sites

Atlanta Dermatology & Vein Research Center, LLC
Alpharetta, Georgia, 30022
Arlington Center for Dermatology
Arlington, Texas, 76011
Skin Care Research, Inc.
Boca Raton, Florida, 33486
Cherry Creek Research, Inc.
Denver, Colorado, 80209
Dawes Fretzin Clinical Research Group
Indianapolis, Indiana, 46260
The Skin Wellness Center, PC
Knoxville, Tennessee, 37922
SKINQRI
Lincolnshire, Illinois, 60069
DermResearch, PLLC
Louisville, Kentucky, 40217
FXM Research
Miami, Florida, 33175
University of Miami Cosmetic Medicine and Research Institute
Miami Beach, Florida, 33140
Dermatology Associates of Rochester, PC
Rochester, New York, 14623
Progressive Clinical Research
San Antonio, Texas, 78229
Rady Children's Hospital San Diego, Div. of Pediatric & Adolescents Dermatology
San Diego, California, 92123
The Laser Institute for Dermatology
Santa Monica, California, 90404
DermResearch Center of New York
Stony Brook, New York, 11790
Somerset Skin Centre
Troy, Michigan, 48084

Other trials in United States

Canada6 sites

Dermatrial Research
Hamilton, Ontario, L8N 1V6
Lynderm Research, Inc.
Markham, Ontario, L3P 1A8
North Bay Dermatology Centre
North Bay, Ontario, P1B3Z7
CRDQ Centre de Recherche Dermatologique du Quebec
Québec, Quebec, G1V 4X7
Nexus Clinical Research
St. John's, NL A1B 3E1
Guildford Dermatology Specialist
Surrey, British Columbia, V3R6A7

Other trials in Canada

Belize2 sites

Dermatology and Skin Care Center FXM Research International
Belize City
Dr. Moguel's Clinic/FXM Research International
Belize City

About this study

Official title: A Phase 3 Multicenter, Randomized, Double-Blind, Active And Vehicle-Controlled Study Of The Safety And Efficacy Of A Clindamycin / Benzoyl Peroxide Gel Versus Clindamycin Gel Versus Benzoyl Peroxide Gel Versus Vehicle Gel In Subjects With Acne Vulgaris

This is a Randomized, Double-Blind, Controlled Study to evaluate the Safety and Efficacy of a clindamycin / benzoyl peroxide gel in Subjects with Acne Vulgaris

Read the detailed description

A multicenter, randomized, double-blind, comparator and vehicle-controlled study in subjects with acne vulgaris. Approximately 1320 subjects will be enrolled. Subjects will be randomized to 1 of 4 parallel study groups in a 1:1:1:1 ratio (clindamycin / benzoyl peroxide gel:clindamycin gel:BPO gel:vehicle gel).

Conditions: Acne Vulgaris
Being tested: clindamycin / benzoyl peroxide gel, clindamycin gel, BPO gel, vehicle 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.

clindamycin / benzoyl peroxide gelDrug
Once a day application to the face
clindamycin gelDrug
Once a day application to the face
BPO gelDrug
Once a day application to the face
vehicle gelDrug
Once a day application to the face

Study groups in NCT00776919
Study group	Role	What they receive
1	Experimental	clindamycin / benzoyl peroxide gel Receives: Drug: clindamycin / benzoyl peroxide gel
2	Active comparator	Clindamycin gel Receives: Drug: clindamycin gel
3	Active comparator	BPO gel Receives: Drug: BPO gel
4	Placebo comparator	vehicle gel Receives: Drug: vehicle gel

What is being measured

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

Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12
During each study visit, investigators/assessors evaluated acne severity of the participants' faces using the ISGA scale: 0=clear skin with no lesions (L); 1=almost clear, rare non-inflammatory L; 2=mild, some non-inflammatory L with no more than a few inflammatory L, no nodular L; 3=moderate, many non-inflammatory L, may have some inflammatory L, but no more than 1 small nodular L; 4=severe, many non-inflammatory and inflammatory L, but no more than a few nodular L; 5=very severe, many non-inflammatory and inflammatory L, and more than a few nodular L.
Measured: Baseline (Day 1) and Week 12
Mean Change From Baseline (BL) to Week 12 in Inflammatory Lesion Counts
During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules [small inflamed elevation of the skin that is filled with pus], papules [solid elevation of skin with no visible fluid], nodules [larger than papules with significant depth]) lesion counts for each participant. Each type of lesion was counted separately, and counts were taken from the face (including forehead, nose, cheeks, and chin). Missing values were imputed using the last observation carried forward (LOCF) method.
Measured: Baseline (Day 1) and Week 12
Mean Change From Baseline to Week 12 in Non-inflammatory Lesion Counts
During each study visit, trained study personnel at every investigational center assessed the non-inflammatory (open comedones [blackheads] and closed comedones [whiteheads]) lesion counts for each participant. Each type of lesion was counted separately, and counts were taken from the face (including forehead, nose, cheeks, and chin).
Measured: Baseline (Day 1) and Week 12
Mean Change From Baseline to Week 12 in Total Lesion Counts
During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules, papules, nodules) and non-inflammatory (open and closed comedones) lesion counts for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face (including forehead, nose, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts.
Measured: Baseline (Day 1) and Week 12

Secondary outcomes (10)

Mean Percent Change From Baseline to Week 12 in Lesion Counts (Total, Inflammatory, and Non-inflammatory)
During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules, papules, nodules) and non-inflammatory (open and closed comedones) lesion counts for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face (including forehead, nose, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts. Percent change from Baseline to Week 12 was calculated as the value at Week 12 minus the value at Baseline divided by the Baseline value * 100.
Measured: Baseline (Day 1) and Week 12
Number of Participants Who Had a Subject Global Assessment (SGA) Score of 0 or 1 at Week 12
During each study visit, participants evaluated their facial acne (excluding the scalp) using the SGA scale: 0=free of acne, with only an occasional blackhead/whitehead; 1=several blackheads/whiteheads and small pimples, no tender deep-seated bumps/cysts; 2=several to many blackheads/whiteheads and small to medium-sized pimples, one deep-seated bump/cyst; 3=many blackheads/whiteheads, many medium- to large-sized pimples, few deep-seated bumps/cysts; 4=presence of blackheads/whiteheads, several to many medium- to large-sized pimples, deep-seated bumps/cysts dominate.
Measured: Week 12
Number of Participants Who Had an ISGA Score of 0 or 1 at Week 12
During each study visit, investigators/assessors evaluated the acne severity of participants' faces using the ISGA scal: 0=clear skin with no lesions (L); 1=almost clear, rare non-inflammatory L; 2=mild, some non-inflammatory L with no more than a few inflammatory L, no nodular L; 3=moderate, many non-inflammatory L, may have some inflammatory L, but no more than 1 small nodular L; 4=severe, many non-inflammatory and inflammatory L, but no more than a few nodular L; 5=very severe, many non-inflammatory and inflammatory L, and more than a few nodular L.
Measured: Week 12
Mean Change From Baseline to Week 12 in Systolic and Diastolic Blood Pressure
Systolic and diastolic blood pressure were measured at Baseline and Week 12 (end of study). Mean change from Baseline was calculated as the mean value at Week 12 minus the mean value at Baseline.
Measured: Baseline (Day 1) and Week 12
Mean Change From Baseline to Week 12 in Temperature
Temperature was measured at Baseline and Week 12 (end of study). Mean change from Baseline was calculated as the mean value at Week 12 minus the mean value at Baseline.
Measured: Baseline (Day 1) and Week 12
Mean Change From Baseline to Week 12 in Pulse Rate
Pulse rate was measured at Baseline and Week 12 (end of study). Mean change from Baseline was calculated as the mean value at Week 12 minus the mean value at Baseline.
Measured: Baseline (Day 1) and Week 12
Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling
Erythema (Er, redness), dryness (Dr), and peeling (Pn), were evaluated independently by the investigator as: 0 (absent)=no Er, Dr, or Pn; 1 (slight)=faint red/pink coloration (col.), barely perceptible Dr with no flakes or fissure, mild localized Pn; 2 (mild)=light red/pink col., perceptible Dr with no flakes/fissure, mild and diffuse Pn; 3 (moderate)=medium red col., easily noted Dr and flakes but no fissure; 4 (severe)=beet red col., Dr with flakes and fissure, prominent dense Pn. Change from Baseline was calculated as the value at Weeks 2, 4, 8, and 12 minus the the value at Baseline.
Measured: Baseline; Weeks 2, 4, 8, and 12
Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging
Itching and burning/stinging (piercing pain) were evaluated independently by the investigator as: 0 (none)=normal, no discomfort; 1 (slight)=noticeable discomfort that caused intermittent awareness; 2 (moderate)=noticeable discomfort that caused intermittent awareness and interfered occasionally with normal daily activities; 3 (strong)=definite continuous discomfort that interfered with normal daily activities. Change from Baseline was calculated as the value at Weeks 2, 4, 8, and 12 minus the value at Baseline.
Measured: Baseline; Weeks 2, 4, 8, and 12
Mean Duration of Study Product Use
Mean duration of study product use was calculated as the average total duration inclusive of missed applications of the study product.
Measured: Baseline (Day 1) through Week 12
Number of Participants Reporting the Indicated Treatment-emergent Adverse Events (AEs) Resulting in Study Product Discontinuation
An AE included, but was not limited to, any clinically significant worsening of a pre-existing condition; an event occurring from overdose (i.e., a dose higher than that indicated in the protocol) of the study product, whether accidental or intentional; an event occurring from abuse (e.g., use for nonstudy reasons) of the study product; or an event that was associated with the discontinuation of the use of the study product.
Measured: Baseline (Day 1) through Week 12

Timeline

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

Oct 2008Sep 2009

First posted22 Oct 2008 (estimated)
Study startOct 2008
Primary completionSep 2009
Study completionSep 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 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,315 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00776919
Sponsor's protocol ID: 114677
Status last verified: Oct 2016
First submitted: 21 Oct 2008
Last updated: 23 Nov 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

Eichenfield LF, Alio Saenz AB. Safety and efficacy of clindamycin phosphate 1.2%-benzoyl peroxide 3% fixed-dose combination gel for the treatment of acne vulgaris: a phase 3, multicenter, randomized, double-blind, active- and vehicle-controlled study. J Drugs Dermatol. 2011 Dec;10(12):1382-96.
PubMed 22134562

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.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal

All Acne Vulgaris trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3 Multicenter, Randomized, Double-Blind, Active And Vehicle-Controlled Study Of The Safety And Efficacy Of A Clindamycin / Benzoyl Peroxide Gel Versus Clindamycin Gel Versus Benzoyl Peroxide Gel Versus Vehicle Gel In Subjects With Acne Vulgaris
ClinicalTrials.gov ID: NCT00776919
Acronym / sponsor ID: 114677
Conditions: Acne Vulgaris
Keywords: Acne Vulgaris, Acne
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,315 participants (actual)
Lead sponsor: Stiefel, a GSK CompanyIndustry (pharma, biotech, devices)
Collaborators: Rho, Inc., Quintiles, Inc., GlaxoSmithKline
Study start: Oct 2008
Primary completion: Sep 2009 (actual)
Study completion: Sep 2009 (actual)
First posted: 22 Oct 2008 (estimated)
Results: Posted 30 Jan 2012

Clinical summary

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

This is a Randomized, Double-Blind, Controlled Study to evaluate the Safety and Efficacy of a clindamycin / benzoyl peroxide gel in Subjects with Acne Vulgaris

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
1	Experimental	Drug: clindamycin / benzoyl peroxide gelclindamycin / benzoyl peroxide gel
2	Active comparator	Drug: clindamycin gelClindamycin gel
3	Active comparator	Drug: BPO gelBPO gel
4	Placebo comparator	Drug: vehicle gelvehicle gel

Who may qualify

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

Key inclusion criteria (5 listed)

Be 12 to 45 years of age, inclusive, and in good general health.
Clinical diagnosis of acne vulgaris
Females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product.
Have the ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.
Have the ability to understand and sign a written informed consent form, which must be completed prior to study specific tasks being performed. Subjects under the legal age of consent in the state/province/country where the study is conducted must provide assent and have the written informed consent of a parent or guardian.

Key exclusion criteria (11 listed)

Are pregnant or breast-feeding.
Have a history or presence of other conditions that may increase the risk of the subject participating in the study and/or affect the evaluated outcomes.
Used topical antibiotics on the face or used systemic antibiotics within the past 2 weeks.
Used topical corticosteroids on the face or systemic corticosteroids within the past 4 weeks. Use of inhaled, intra-articular, or intra-lesional steroids other than for facial acne is acceptable.
Used systemic retinoids within the past 6 months or topical retinoids within the past 6 weeks.

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
clindamycin / benzoyl peroxide gelOnce a day application to the face	Drug	1
clindamycin gelOnce a day application to the face	Drug	2
BPO gelOnce a day application to the face	Drug	3
vehicle gelOnce a day application to the face	Drug	4

Primary outcome

Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12
Time frame: Baseline (Day 1) and Week 12
During each study visit, investigators/assessors evaluated acne severity of the participants' faces using the ISGA scale: 0=clear skin with no lesions (L); 1=almost clear, rare non-inflammatory L; 2=mild, some non-inflammatory L with no more than a few inflammatory L, no nodular L; 3=moderate, many non-inflammatory L, may have some inflammatory L, but no more than 1 small nodular L; 4=severe, many non-inflammatory and inflammatory L, but no more than a few nodular L; 5=very severe, many non-inflammatory and inflammatory L, and more than a few nodular L.
Mean Change From Baseline (BL) to Week 12 in Inflammatory Lesion Counts
Time frame: Baseline (Day 1) and Week 12
During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules [small inflamed elevation of the skin that is filled with pus], papules [solid elevation of skin with no visible fluid], nodules [larger than papules with significant depth]) lesion counts for each participant. Each type of lesion was counted separately, and counts were taken from the face (including forehead, nose, cheeks, and chin). Missing values were imputed using the last observation carried forward (LOCF) method.
Mean Change From Baseline to Week 12 in Non-inflammatory Lesion Counts
Time frame: Baseline (Day 1) and Week 12
During each study visit, trained study personnel at every investigational center assessed the non-inflammatory (open comedones [blackheads] and closed comedones [whiteheads]) lesion counts for each participant. Each type of lesion was counted separately, and counts were taken from the face (including forehead, nose, cheeks, and chin).
Mean Change From Baseline to Week 12 in Total Lesion Counts
Time frame: Baseline (Day 1) and Week 12
During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules, papules, nodules) and non-inflammatory (open and closed comedones) lesion counts for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face (including forehead, nose, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts.

10 secondary outcomes

Mean Percent Change From Baseline to Week 12 in Lesion Counts (Total, Inflammatory, and Non-inflammatory)
Time frame: Baseline (Day 1) and Week 12
Number of Participants Who Had a Subject Global Assessment (SGA) Score of 0 or 1 at Week 12
Time frame: Week 12
Number of Participants Who Had an ISGA Score of 0 or 1 at Week 12
Time frame: Week 12
Mean Change From Baseline to Week 12 in Systolic and Diastolic Blood Pressure
Time frame: Baseline (Day 1) and Week 12
Mean Change From Baseline to Week 12 in Temperature
Time frame: Baseline (Day 1) and Week 12
Mean Change From Baseline to Week 12 in Pulse Rate
Time frame: Baseline (Day 1) and Week 12
Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling
Time frame: Baseline; Weeks 2, 4, 8, and 12
Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging
Time frame: Baseline; Weeks 2, 4, 8, and 12
Mean Duration of Study Product Use
Time frame: Baseline (Day 1) through Week 12
Number of Participants Reporting the Indicated Treatment-emergent Adverse Events (AEs) Resulting in Study Product Discontinuation
Time frame: Baseline (Day 1) through Week 12

Results and safety

Results posted to the registry on 30 Jan 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
Duac Low-dose (LD) Gel	327	300
Clindamycin Gel	328	295
BPO Gel	328	296
Vehicle Gel	332	293

Primary outcome: Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12

Time frame: Baseline (Day 1) and Week 12. Number. Unit: participants

Measure	Duac Low-dose (LD) Gel n = 327	Clindamycin Gel n = 328	BPO Gel n = 328	Vehicle Gel n = 332
Value	129	82	100	59

Duac Low-dose (LD) Gel vs Clindamycin Gel: p <0.001, Cochran-Mantel-Haenszel
Duac Low-dose (LD) Gel vs BPO Gel: p = 0.016, Cochran-Mantel-Haenszel
Duac Low-dose (LD) Gel vs Vehicle Gel: p <0.001, Cochran-Mantel-Haenszel

Population analysed: Intent-to-Treat (ITT) Population: all participants who were randomized to and received at least 1 application of study product. Participants with missing Week 12 evaluations were considered failures. Failures are defined as those participants with a 1-grade improvement, no improvement, or a worsening.

Primary outcome: Mean Change From Baseline (BL) to Week 12 in Inflammatory Lesion Counts

Time frame: Baseline (Day 1) and Week 12. Mean (Standard Deviation). Unit: lesion counts

Measure	Duac Low-dose (LD) Gel n = 322	Clindamycin Gel n = 318	BPO Gel n = 323	Vehicle Gel n = 329
Value	-18.2 (10.4)	-15.6 (11.6)	-16.8 (11.5)	-13.1 (12.1)

Duac Low-dose (LD) Gel vs Clindamycin Gel: p <0.001, ANCOVA
Duac Low-dose (LD) Gel vs BPO Gel: p = 0.015, ANCOVA
Duac Low-dose (LD) Gel vs Vehicle Gel: p <0.001, ANCOVA

Population analysed: ITT Population. Participants who missed \>=16 days of treatment or reported lost medication and never began treatment were excluded from the analysis. In the LOCF method, the last available observation, including BL, was used to estimate subsequent missing data points.

Primary outcome: Mean Change From Baseline to Week 12 in Non-inflammatory Lesion Counts

Time frame: Baseline (Day 1) and Week 12. Mean (Standard Deviation). Unit: lesion counts

Measure	Duac Low-dose (LD) Gel n = 322	Clindamycin Gel n = 318	BPO Gel n = 323	Vehicle Gel n = 329
Value	-24.8 (20.1)	-19.8 (19.8)	-22.2 (17.6)	-14.8 (21.6)

Duac Low-dose (LD) Gel vs Clindamycin Gel: p <0.001, ANCOVA
Duac Low-dose (LD) Gel vs BPO Gel: p = 0.102, ANCOVA
Duac Low-dose (LD) Gel vs Vehicle Gel: p <0.001, ANCOVA

Population analysed: ITT Population. Participants who missed \>=16 days of treatment or who reported they had lost their medication and never began treatment were excluded from the analysis. Missing values for all other participants were imputed using the LOCF method.

Primary outcome: Mean Change From Baseline to Week 12 in Total Lesion Counts

Time frame: Baseline (Day 1) and Week 12. Mean (Standard Deviation). Unit: lesion counts

Measure	Duac Low-dose (LD) Gel n = 322	Clindamycin Gel n = 318	BPO Gel n = 323	Vehicle Gel n = 329
Value	-43.0 (27.1)	-35.5 (27.1)	-39.0 (25.0)	-27.8 (29.8)

Duac Low-dose (LD) Gel vs Clindamycin Gel: p <0.001, ANCOVA
Duac Low-dose (LD) Gel vs BPO Gel: p = 0.032, ANCOVA
Duac Low-dose (LD) Gel vs Vehicle Gel: p <0.001, ANCOVA

10 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
Duac Low-dose (LD) Gel	0 of 327 (0%)	72 of 327 (22%)	Not reported
Clindamycin Gel	0 of 328 (0%)	83 of 328 (25.3%)	Not reported
BPO Gel	1 of 328 (0.3%)	102 of 328 (31.1%)	Not reported
Vehicle Gel	0 of 332 (0%)	87 of 332 (26.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 22134562Eichenfield LF, Alio Saenz AB. Safety and efficacy of clindamycin phosphate 1.2%-benzoyl peroxide 3% fixed-dose combination gel for the treatment of acne vulgaris: a phase 3, multicenter, randomized, double-blind, active- and vehicle-controlled study. J Drugs Dermatol. 2011 Dec;10(12):1382-96.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal

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

24 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing clindamycin / benzoyl peroxide gel, clindamycin gel and BPO gel in people with Acne Vulgaris, run by Stiefel, a GSK Company at 24 sites in 3 countries.

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 5 inclusion and 11 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 23 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States, Canada, Belize. 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 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 30 Jan 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?

Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12 (time frame: Baseline (Day 1) and Week 12). 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 NCT00776919, 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 23 Nov 2016.