Trial · NCT00776919

Trial of Clindamycin / Benzoyl Peroxide Gel in Subjects With Acne

NCT00776919, Phase 3, Completed, Stiefel, a GSK Company; results first posted 2012-01-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Trial of Clindamycin / Benzoyl Peroxide Gel in Subjects With Acne. Trials, record NCT00776919. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00776919

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Trial of Clindamycin / Benzoyl Peroxide Gel in Subjects With Acne
NCT number: NCT00776919
Status: Completed
Phases: Phase 3
Enrollment: 1,315 participants, actual
Lead sponsor: Stiefel, a GSK Company
Conditions: Acne Vulgaris
Interventions: clindamycin / benzoyl peroxide gel, clindamycin gel, BPO gel, vehicle gel
First posted: 2008-10-22
Last updated: 2016-11-23
Results first posted: 2012-01-30

Source ClinicalTrials.gov

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12	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.
Primary	Mean Change From Baseline (BL) to Week 12 in Inflammatory Lesion Counts	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.
Primary	Mean Change From Baseline to Week 12 in Non-inflammatory Lesion Counts	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).
Primary	Mean Change From Baseline to Week 12 in Total Lesion Counts	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.
Secondary	Mean Percent Change From Baseline to Week 12 in Lesion Counts (Total, Inflammatory, and Non-inflammatory)	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. 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.
Secondary	Number of Participants Who Had a Subject Global Assessment (SGA) Score of 0 or 1 at Week 12	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.
Secondary	Number of Participants Who Had an ISGA Score of 0 or 1 at Week 12	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.
Secondary	Mean Change From Baseline to Week 12 in Systolic and Diastolic Blood Pressure	Baseline (Day 1) and Week 12	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.
Secondary	Mean Change From Baseline to Week 12 in Temperature	Baseline (Day 1) and Week 12	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.
Secondary	Mean Change From Baseline to Week 12 in Pulse Rate	Baseline (Day 1) and Week 12	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.

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes14

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12	Baseline (Day 1) and Week 12	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.	participants	NUMBER
PRIMARY	Mean Change From Baseline (BL) to Week 12 in Inflammatory Lesion Counts	Baseline (Day 1) and Week 12	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.	lesion counts	MEAN
PRIMARY	Mean Change From Baseline to Week 12 in Non-inflammatory Lesion Counts	Baseline (Day 1) and Week 12	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.	lesion counts	MEAN
PRIMARY	Mean Change From Baseline to Week 12 in Total Lesion Counts	Baseline (Day 1) and Week 12	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.	lesion counts	MEAN
SECONDARY	Mean Percent Change From Baseline to Week 12 in Lesion Counts (Total, Inflammatory, and Non-inflammatory)	Baseline (Day 1) and Week 12	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.	Percent change in lesion counts	MEAN
SECONDARY	Number of Participants Who Had a Subject Global Assessment (SGA) Score of 0 or 1 at Week 12	Week 12	ITT Population. Participants with missing Week 12 evaluations were considered failures. Failures were defined as those participants with an SGA score \>=2.	participants	NUMBER
SECONDARY	Number of Participants Who Had an ISGA Score of 0 or 1 at Week 12	Week 12	ITT Population. Participants with missing Week 12 evaluations were considered failures. Failures were defined as those participants with an ISGA score \>=2.	participants	NUMBER
SECONDARY	Mean Change From Baseline to Week 12 in Systolic and Diastolic Blood Pressure	Baseline (Day 1) and Week 12	ITT Population. Only those participants with data available at both Baseline and Week 12 were analyzed.	Millimeters of mercury (mmHg)	MEAN
SECONDARY	Mean Change From Baseline to Week 12 in Temperature	Baseline (Day 1) and Week 12	ITT Population. Only those participants with data available at both Baseline and Week 12 were analyzed.	Degrees centigrade	MEAN
SECONDARY	Mean Change From Baseline to Week 12 in Pulse Rate	Baseline (Day 1) and Week 12	ITT Population. Only those participants with data available at both Baseline and Week 12 were analyzed.	Beats per minute (bpm)	MEAN

1 to 10 of 14Source ClinicalTrials.gov

See all 14 outcomes

Results by group152

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12	Duac Low-dose (LD) Gel	129		participants
Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12	Clindamycin Gel	82		participants
Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12	BPO Gel	100		participants
Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12	Vehicle Gel	59		participants
Mean Change From Baseline (BL) to Week 12 in Inflammatory Lesion Counts	Duac Low-dose (LD) Gel	-18.2	Standard Deviation 10.4	lesion counts
Mean Change From Baseline (BL) to Week 12 in Inflammatory Lesion Counts	Clindamycin Gel	-15.6	Standard Deviation 11.6	lesion counts
Mean Change From Baseline (BL) to Week 12 in Inflammatory Lesion Counts	BPO Gel	-16.8	Standard Deviation 11.5	lesion counts
Mean Change From Baseline (BL) to Week 12 in Inflammatory Lesion Counts	Vehicle Gel	-13.1	Standard Deviation 12.1	lesion counts
Mean Change From Baseline to Week 12 in Non-inflammatory Lesion Counts	Duac Low-dose (LD) Gel	-24.8	Standard Deviation 20.1	lesion counts
Mean Change From Baseline to Week 12 in Non-inflammatory Lesion Counts	Clindamycin Gel	-19.8	Standard Deviation 19.8	lesion counts

1 to 10 of 152Source ClinicalTrials.gov

See all 152 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Duac Low-dose (LD) Gel	327
Overall Study	STARTED	Clindamycin Gel	328
Overall Study	STARTED	BPO Gel	328
Overall Study	STARTED	Vehicle Gel	332
Overall Study	COMPLETED	Duac Low-dose (LD) Gel	300
Overall Study	COMPLETED	Clindamycin Gel	295
Overall Study	COMPLETED	BPO Gel	296
Overall Study	COMPLETED	Vehicle Gel	293
Overall Study	NOT COMPLETED	Duac Low-dose (LD) Gel	27
Overall Study	NOT COMPLETED	Clindamycin Gel	33

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events572

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Iron Deficiency Anemia	Blood and lymphatic system disorders	Duac Low-dose (LD) Gel	1	327
other	Iron Deficiency Anemia	Blood and lymphatic system disorders	Clindamycin Gel	0	328
other	Iron Deficiency Anemia	Blood and lymphatic system disorders	BPO Gel	0	328
other	Iron Deficiency Anemia	Blood and lymphatic system disorders	Vehicle Gel	0	332
other	Lymphadenopathy	Blood and lymphatic system disorders	Duac Low-dose (LD) Gel	0	327
other	Lymphadenopathy	Blood and lymphatic system disorders	Clindamycin Gel	1	328
other	Lymphadenopathy	Blood and lymphatic system disorders	BPO Gel	0	328
other	Lymphadenopathy	Blood and lymphatic system disorders	Vehicle Gel	1	332
other	Ear Congestion	Ear and labyrinth disorders	Duac Low-dose (LD) Gel	1	327
other	Ear Congestion	Ear and labyrinth disorders	Clindamycin Gel	0	328

1 to 10 of 572Source ClinicalTrials.gov

See all 572 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Duac Low-dose (LD) Gel
Total, all-cause mortality	Clindamycin Gel
Total, all-cause mortality	BPO Gel
Total, all-cause mortality	Vehicle Gel
Total, other adverse events	Duac Low-dose (LD) Gel	72	327
Total, other adverse events	Clindamycin Gel	83	328
Total, other adverse events	BPO Gel	102	328
Total, other adverse events	Vehicle Gel	87	332
Total, serious adverse events	Duac Low-dose (LD) Gel	0	327
Total, serious adverse events	Clindamycin Gel	0	328

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
22134562	BACKGROUND

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Read this trial from software.

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