Trial Outcomes & Findings for Trial of Clindamycin / Benzoyl Peroxide Gel in Subjects With Acne (NCT NCT00776919)
NCT ID: NCT00776919
Last Updated: 2016-11-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1315 participants
Primary outcome timeframe
Baseline (Day 1) and Week 12
Results posted on
2016-11-23
Participant Flow
Participant milestones
| Measure |
Duac Low-dose (LD) Gel
Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
Clindamycin Gel
Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
BPO Gel
Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
Vehicle Gel
Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
327
|
328
|
328
|
332
|
|
Overall Study
COMPLETED
|
300
|
295
|
296
|
293
|
|
Overall Study
NOT COMPLETED
|
27
|
33
|
32
|
39
|
Reasons for withdrawal
| Measure |
Duac Low-dose (LD) Gel
Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
Clindamycin Gel
Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
BPO Gel
Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
Vehicle Gel
Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
16
|
14
|
15
|
26
|
|
Overall Study
Lost to Follow-up
|
8
|
12
|
11
|
8
|
|
Overall Study
Adverse Event
|
1
|
0
|
2
|
2
|
|
Overall Study
Protocol Violation
|
1
|
2
|
0
|
1
|
|
Overall Study
Other: Lack of Efficacy/Lost Medication
|
1
|
5
|
4
|
2
|
Baseline Characteristics
Trial of Clindamycin / Benzoyl Peroxide Gel in Subjects With Acne
Baseline characteristics by cohort
| Measure |
Duac Low-dose (LD) Gel
n=327 Participants
Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
Clindamycin Gel
n=328 Participants
Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
BPO Gel
n=328 Participants
Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
Vehicle Gel
n=332 Participants
Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
Total
n=1315 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
20.0 Years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
20.2 Years
STANDARD_DEVIATION 6.9 • n=7 Participants
|
20.6 Years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
20.7 Years
STANDARD_DEVIATION 7.4 • n=4 Participants
|
20.4 Years
STANDARD_DEVIATION 7.1 • n=21 Participants
|
|
Sex: Female, Male
Female
|
202 Participants
n=5 Participants
|
180 Participants
n=7 Participants
|
203 Participants
n=5 Participants
|
210 Participants
n=4 Participants
|
795 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
125 Participants
n=5 Participants
|
148 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
122 Participants
n=4 Participants
|
520 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
259 participants
n=5 Participants
|
274 participants
n=7 Participants
|
251 participants
n=5 Participants
|
258 participants
n=4 Participants
|
1042 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black
|
47 participants
n=5 Participants
|
37 participants
n=7 Participants
|
54 participants
n=5 Participants
|
54 participants
n=4 Participants
|
192 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
13 participants
n=5 Participants
|
9 participants
n=7 Participants
|
17 participants
n=5 Participants
|
16 participants
n=4 Participants
|
55 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
5 participants
n=5 Participants
|
7 participants
n=7 Participants
|
7 participants
n=5 Participants
|
4 participants
n=4 Participants
|
23 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
4 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: 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.
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.
Outcome measures
| Measure |
Duac Low-dose (LD) Gel
n=327 Participants
Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
Clindamycin Gel
n=328 Participants
Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
BPO Gel
n=328 Participants
Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
Vehicle Gel
n=332 Participants
Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
|---|---|---|---|---|
|
Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12
|
129 participants
|
82 participants
|
100 participants
|
59 participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: 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.
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.
Outcome measures
| Measure |
Duac Low-dose (LD) Gel
n=322 Participants
Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
Clindamycin Gel
n=318 Participants
Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
BPO Gel
n=323 Participants
Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
Vehicle Gel
n=329 Participants
Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
|---|---|---|---|---|
|
Mean Change From Baseline (BL) to Week 12 in Inflammatory Lesion Counts
|
-18.2 lesion counts
Standard Deviation 10.4
|
-15.6 lesion counts
Standard Deviation 11.6
|
-16.8 lesion counts
Standard Deviation 11.5
|
-13.1 lesion counts
Standard Deviation 12.1
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: 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.
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).
Outcome measures
| Measure |
Duac Low-dose (LD) Gel
n=322 Participants
Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
Clindamycin Gel
n=318 Participants
Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
BPO Gel
n=323 Participants
Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
Vehicle Gel
n=329 Participants
Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
|---|---|---|---|---|
|
Mean Change From Baseline to Week 12 in Non-inflammatory Lesion Counts
|
-24.8 lesion counts
Standard Deviation 20.1
|
-19.8 lesion counts
Standard Deviation 19.8
|
-22.2 lesion counts
Standard Deviation 17.6
|
-14.8 lesion counts
Standard Deviation 21.6
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: 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.
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.
Outcome measures
| Measure |
Duac Low-dose (LD) Gel
n=322 Participants
Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
Clindamycin Gel
n=318 Participants
Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
BPO Gel
n=323 Participants
Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
Vehicle Gel
n=329 Participants
Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
|---|---|---|---|---|
|
Mean Change From Baseline to Week 12 in Total Lesion Counts
|
-43.0 lesion counts
Standard Deviation 27.1
|
-35.5 lesion counts
Standard Deviation 27.1
|
-39.0 lesion counts
Standard Deviation 25.0
|
-27.8 lesion counts
Standard Deviation 29.8
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: 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.
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.
Outcome measures
| Measure |
Duac Low-dose (LD) Gel
n=322 Participants
Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
Clindamycin Gel
n=318 Participants
Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
BPO Gel
n=323 Participants
Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
Vehicle Gel
n=329 Participants
Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
|---|---|---|---|---|
|
Mean Percent Change From Baseline to Week 12 in Lesion Counts (Total, Inflammatory, and Non-inflammatory)
Inflammatory Lesions
|
-68.9 Percent change in lesion counts
Standard Deviation 29.6
|
-58.1 Percent change in lesion counts
Standard Deviation 35.8
|
-61.8 Percent change in lesion counts
Standard Deviation 31.5
|
-48.8 Percent change in lesion counts
Standard Deviation 37.1
|
|
Mean Percent Change From Baseline to Week 12 in Lesion Counts (Total, Inflammatory, and Non-inflammatory)
Non-inflammatory Lesions
|
-53.9 Percent change in lesion counts
Standard Deviation 32.2
|
-43.3 Percent change in lesion counts
Standard Deviation 39.6
|
-50.8 Percent change in lesion counts
Standard Deviation 33.5
|
-34.0 Percent change in lesion counts
Standard Deviation 47.2
|
|
Mean Percent Change From Baseline to Week 12 in Lesion Counts (Total, Inflammatory, and Non-inflammatory)
Total Lesions
|
-59.8 Percent change in lesion counts
Standard Deviation 28.0
|
-49.2 Percent change in lesion counts
Standard Deviation 33.8
|
-55.5 Percent change in lesion counts
Standard Deviation 28.8
|
-40.4 Percent change in lesion counts
Standard Deviation 37.5
|
SECONDARY outcome
Timeframe: Week 12Population: ITT Population. Participants with missing Week 12 evaluations were considered failures. Failures were defined as those participants with an SGA score \>=2.
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.
Outcome measures
| Measure |
Duac Low-dose (LD) Gel
n=327 Participants
Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
Clindamycin Gel
n=328 Participants
Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
BPO Gel
n=328 Participants
Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
Vehicle Gel
n=332 Participants
Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
|---|---|---|---|---|
|
Number of Participants Who Had a Subject Global Assessment (SGA) Score of 0 or 1 at Week 12
|
209 participants
|
171 participants
|
189 participants
|
154 participants
|
SECONDARY outcome
Timeframe: Week 12Population: ITT Population. Participants with missing Week 12 evaluations were considered failures. Failures were defined as those participants with an ISGA score \>=2.
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.
Outcome measures
| Measure |
Duac Low-dose (LD) Gel
n=327 Participants
Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
Clindamycin Gel
n=328 Participants
Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
BPO Gel
n=328 Participants
Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
Vehicle Gel
n=332 Participants
Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
|---|---|---|---|---|
|
Number of Participants Who Had an ISGA Score of 0 or 1 at Week 12
|
148 participants
|
91 participants
|
116 participants
|
81 participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: ITT Population. Only those participants with data available at both Baseline and Week 12 were analyzed.
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.
Outcome measures
| Measure |
Duac Low-dose (LD) Gel
n=305 Participants
Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
Clindamycin Gel
n=302 Participants
Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
BPO Gel
n=305 Participants
Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
Vehicle Gel
n=309 Participants
Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
|---|---|---|---|---|
|
Mean Change From Baseline to Week 12 in Systolic and Diastolic Blood Pressure
Systolic blood pressure
|
0 Millimeters of mercury (mmHg)
Standard Deviation 10
|
0 Millimeters of mercury (mmHg)
Standard Deviation 11
|
0 Millimeters of mercury (mmHg)
Standard Deviation 12
|
0 Millimeters of mercury (mmHg)
Standard Deviation 10
|
|
Mean Change From Baseline to Week 12 in Systolic and Diastolic Blood Pressure
Diastolic blood pressure
|
0 Millimeters of mercury (mmHg)
Standard Deviation 8
|
1 Millimeters of mercury (mmHg)
Standard Deviation 9
|
0 Millimeters of mercury (mmHg)
Standard Deviation 8
|
0 Millimeters of mercury (mmHg)
Standard Deviation 8
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: ITT Population. Only those participants with data available at both Baseline and Week 12 were analyzed.
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.
Outcome measures
| Measure |
Duac Low-dose (LD) Gel
n=304 Participants
Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
Clindamycin Gel
n=302 Participants
Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
BPO Gel
n=305 Participants
Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
Vehicle Gel
n=309 Participants
Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
|---|---|---|---|---|
|
Mean Change From Baseline to Week 12 in Temperature
|
-0.1 Degrees centigrade
Standard Deviation 0.4
|
0.0 Degrees centigrade
Standard Deviation 0.4
|
0.0 Degrees centigrade
Standard Deviation 0.4
|
0.0 Degrees centigrade
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 12Population: ITT Population. Only those participants with data available at both Baseline and Week 12 were analyzed.
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.
Outcome measures
| Measure |
Duac Low-dose (LD) Gel
n=305 Participants
Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
Clindamycin Gel
n=302 Participants
Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
BPO Gel
n=304 Participants
Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
Vehicle Gel
n=309 Participants
Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
|---|---|---|---|---|
|
Mean Change From Baseline to Week 12 in Pulse Rate
|
1 Beats per minute (bpm)
Standard Deviation 10
|
2 Beats per minute (bpm)
Standard Deviation 11
|
2 Beats per minute (bpm)
Standard Deviation 9
|
2 Beats per minute (bpm)
Standard Deviation 11
|
SECONDARY outcome
Timeframe: Baseline; Weeks 2, 4, 8, and 12Population: ITT Population. Only those participants with data available at both Baseline and the indicated assessment week were analyzed.
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.
Outcome measures
| Measure |
Duac Low-dose (LD) Gel
n=298 Participants
Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
Clindamycin Gel
n=302 Participants
Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
BPO Gel
n=306 Participants
Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
Vehicle Gel
n=306 Participants
Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
|---|---|---|---|---|
|
Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling
Erythema, Week 8, n=297, 296, 294, 293
|
-0.12 scores on a scale
Standard Deviation 0.71
|
-0.08 scores on a scale
Standard Deviation 0.67
|
-0.15 scores on a scale
Standard Deviation 0.68
|
-0.08 scores on a scale
Standard Deviation 0.73
|
|
Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling
Erythema, Week 2, n=298, 302, 306, 306
|
-0.05 scores on a scale
Standard Deviation 0.63
|
-0.01 scores on a scale
Standard Deviation 0.58
|
-0.07 scores on a scale
Standard Deviation 0.56
|
-0.02 scores on a scale
Standard Deviation 0.61
|
|
Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling
Erythema, Week 4, n=298, 300, 299, 306
|
-0.07 scores on a scale
Standard Deviation 0.66
|
-0.07 scores on a scale
Standard Deviation 0.64
|
-0.08 scores on a scale
Standard Deviation 0.67
|
-0.06 scores on a scale
Standard Deviation 0.64
|
|
Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling
Erythema, Week 12, n=297, 296, 296, 294
|
-0.17 scores on a scale
Standard Deviation 0.66
|
-0.18 scores on a scale
Standard Deviation 0.63
|
-0.17 scores on a scale
Standard Deviation 0.67
|
-0.13 scores on a scale
Standard Deviation 0.69
|
|
Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling
Dryness, Week 2, n=298, 302, 306, 306
|
0.07 scores on a scale
Standard Deviation 0.54
|
0.03 scores on a scale
Standard Deviation 0.48
|
0.09 scores on a scale
Standard Deviation 0.61
|
0.04 scores on a scale
Standard Deviation 0.50
|
|
Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling
Dryness, Week 4, n=298, 300, 299, 306
|
0.05 scores on a scale
Standard Deviation 0.58
|
-0.02 scores on a scale
Standard Deviation 0.51
|
0.08 scores on a scale
Standard Deviation 0.55
|
0.00 scores on a scale
Standard Deviation 0.52
|
|
Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling
Dryness, Week 8, n=297, 296, 294, 293
|
0.00 scores on a scale
Standard Deviation 0.53
|
-0.02 scores on a scale
Standard Deviation 0.58
|
0.05 scores on a scale
Standard Deviation 0.57
|
0.02 scores on a scale
Standard Deviation 0.56
|
|
Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling
Dryness, Week 12, n=297, 296, 296, 294
|
-0.07 scores on a scale
Standard Deviation 0.62
|
-0.10 scores on a scale
Standard Deviation 0.53
|
-0.01 scores on a scale
Standard Deviation 0.57
|
-0.04 scores on a scale
Standard Deviation 0.55
|
|
Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling
Peeling, Week 2, n=298, 302, 306, 306
|
0.03 scores on a scale
Standard Deviation 0.43
|
0.02 scores on a scale
Standard Deviation 0.36
|
0.08 scores on a scale
Standard Deviation 0.51
|
0.02 scores on a scale
Standard Deviation 0.41
|
|
Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling
Peeling, Week 4, n=298, 300, 299, 306
|
-0.01 scores on a scale
Standard Deviation 0.39
|
0.00 scores on a scale
Standard Deviation 0.36
|
0.01 scores on a scale
Standard Deviation 0.39
|
0.00 scores on a scale
Standard Deviation 0.40
|
|
Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling
Peeling, Week 8, n=297, 296, 294, 293
|
-0.01 scores on a scale
Standard Deviation 0.41
|
-0.01 scores on a scale
Standard Deviation 0.42
|
-0.01 scores on a scale
Standard Deviation 0.40
|
0.00 scores on a scale
Standard Deviation 0.43
|
|
Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling
Peeling, Week 12, n=297, 296, 296, 294
|
-0.08 scores on a scale
Standard Deviation 0.44
|
-0.06 scores on a scale
Standard Deviation 0.40
|
-0.02 scores on a scale
Standard Deviation 0.50
|
-0.04 scores on a scale
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: Baseline; Weeks 2, 4, 8, and 12Population: ITT Population. Only those participants with data available at both Baseline and the indicated assessment week were analyzed.
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.
Outcome measures
| Measure |
Duac Low-dose (LD) Gel
n=298 Participants
Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
Clindamycin Gel
n=302 Participants
Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
BPO Gel
n=306 Participants
Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
Vehicle Gel
n=306 Participants
Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
|---|---|---|---|---|
|
Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging
Itching, Week 2, n=297, 301, 305, 305
|
-0.11 scores on a scale
Standard Deviation 0.67
|
-0.18 scores on a scale
Standard Deviation 0.67
|
-0.04 scores on a scale
Standard Deviation 0.64
|
-0.06 scores on a scale
Standard Deviation 0.65
|
|
Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging
Itching, Week 4, n=298, 299, 299, 305
|
-0.11 scores on a scale
Standard Deviation 0.67
|
-0.18 scores on a scale
Standard Deviation 0.68
|
-0.07 scores on a scale
Standard Deviation 0.68
|
-0.10 scores on a scale
Standard Deviation 0.61
|
|
Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging
Itching, Week 8, n=297, 295, 293, 291
|
-0.16 scores on a scale
Standard Deviation 0.75
|
-0.24 scores on a scale
Standard Deviation 0.69
|
-0.08 scores on a scale
Standard Deviation 0.68
|
-0.08 scores on a scale
Standard Deviation 0.62
|
|
Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging
Itching, Week 12, n=297, 295, 294, 293
|
-0.21 scores on a scale
Standard Deviation 0.70
|
-0.28 scores on a scale
Standard Deviation 0.67
|
-0.13 scores on a scale
Standard Deviation 0.72
|
-0.13 scores on a scale
Standard Deviation 0.63
|
|
Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging
Burning/Stinging, Week 2, n=297, 301, 305, 305
|
0.02 scores on a scale
Standard Deviation 0.58
|
-0.06 scores on a scale
Standard Deviation 0.48
|
-0.02 scores on a scale
Standard Deviation 0.56
|
-0.05 scores on a scale
Standard Deviation 0.53
|
|
Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging
Burning/Stinging, Week 4, n=298, 2991, 299, 305
|
-0.06 scores on a scale
Standard Deviation 0.57
|
-0.09 scores on a scale
Standard Deviation 0.46
|
-0.05 scores on a scale
Standard Deviation 0.55
|
-0.02 scores on a scale
Standard Deviation 0.59
|
|
Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging
Burning/Stinging, Week 8, n=297, 295, 293, 291
|
-0.05 scores on a scale
Standard Deviation 0.57
|
-0.09 scores on a scale
Standard Deviation 0.46
|
-0.05 scores on a scale
Standard Deviation 0.55
|
-0.06 scores on a scale
Standard Deviation 0.54
|
|
Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging
Burning/Stinging, Week 12, n=297, 295, 294, 293
|
-0.09 scores on a scale
Standard Deviation 0.58
|
-0.13 scores on a scale
Standard Deviation 0.48
|
-0.04 scores on a scale
Standard Deviation 0.60
|
-0.04 scores on a scale
Standard Deviation 0.49
|
SECONDARY outcome
Timeframe: Baseline (Day 1) through Week 12Population: ITT Population
Mean duration of study product use was calculated as the average total duration inclusive of missed applications of the study product.
Outcome measures
| Measure |
Duac Low-dose (LD) Gel
n=327 Participants
Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
Clindamycin Gel
n=328 Participants
Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
BPO Gel
n=328 Participants
Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
Vehicle Gel
n=332 Participants
Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
|---|---|---|---|---|
|
Mean Duration of Study Product Use
|
79.5 days
Standard Deviation 16.4
|
78.0 days
Standard Deviation 17.9
|
78.0 days
Standard Deviation 18.4
|
77.8 days
Standard Deviation 18.4
|
SECONDARY outcome
Timeframe: Baseline (Day 1) through Week 12Population: ITT Population
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.
Outcome measures
| Measure |
Duac Low-dose (LD) Gel
n=327 Participants
Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
Clindamycin Gel
n=328 Participants
Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
BPO Gel
n=328 Participants
Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
Vehicle Gel
n=332 Participants
Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
|---|---|---|---|---|
|
Number of Participants Reporting the Indicated Treatment-emergent Adverse Events (AEs) Resulting in Study Product Discontinuation
Application Site Dermatitis
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Reporting the Indicated Treatment-emergent Adverse Events (AEs) Resulting in Study Product Discontinuation
Application Site Hypersensitivity
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants Reporting the Indicated Treatment-emergent Adverse Events (AEs) Resulting in Study Product Discontinuation
Application Site Pruritus
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Number of Participants Reporting the Indicated Treatment-emergent Adverse Events (AEs) Resulting in Study Product Discontinuation
Varicella
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
Adverse Events
Duac Low-dose (LD) Gel
Serious events: 0 serious events
Other events: 72 other events
Deaths: 0 deaths
Clindamycin Gel
Serious events: 0 serious events
Other events: 83 other events
Deaths: 0 deaths
BPO Gel
Serious events: 1 serious events
Other events: 102 other events
Deaths: 0 deaths
Vehicle Gel
Serious events: 0 serious events
Other events: 87 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Duac Low-dose (LD) Gel
n=327 participants at risk
Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
Clindamycin Gel
n=328 participants at risk
Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
BPO Gel
n=328 participants at risk
Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
Vehicle Gel
n=332 participants at risk
Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
|---|---|---|---|---|
|
Psychiatric disorders
Depression
|
0.00%
0/327
|
0.00%
0/328
|
0.30%
1/328
|
0.00%
0/332
|
Other adverse events
| Measure |
Duac Low-dose (LD) Gel
n=327 participants at risk
Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
Clindamycin Gel
n=328 participants at risk
Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
BPO Gel
n=328 participants at risk
Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
Vehicle Gel
n=332 participants at risk
Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
|
|---|---|---|---|---|
|
Infections and infestations
Body Tinea
|
0.00%
0/327
|
0.00%
0/328
|
0.00%
0/328
|
0.30%
1/332
|
|
Infections and infestations
Bronchitis
|
0.00%
0/327
|
0.61%
2/328
|
0.30%
1/328
|
0.30%
1/332
|
|
Infections and infestations
Cellulitis
|
0.00%
0/327
|
0.30%
1/328
|
0.00%
0/328
|
0.00%
0/332
|
|
Infections and infestations
Conjunctivitis Infective
|
0.00%
0/327
|
0.00%
0/328
|
0.00%
0/328
|
0.30%
1/332
|
|
Infections and infestations
Ear Infection
|
0.31%
1/327
|
0.00%
0/328
|
0.61%
2/328
|
0.00%
0/332
|
|
Infections and infestations
Folliculitis
|
0.31%
1/327
|
0.00%
0/328
|
0.00%
0/328
|
0.00%
0/332
|
|
Infections and infestations
Fungal Infection
|
0.00%
0/327
|
0.00%
0/328
|
0.30%
1/328
|
0.00%
0/332
|
|
Infections and infestations
Furuncle
|
0.00%
0/327
|
0.00%
0/328
|
0.30%
1/328
|
0.00%
0/332
|
|
Infections and infestations
Gastroenteritis
|
0.31%
1/327
|
0.00%
0/328
|
0.00%
0/328
|
0.30%
1/332
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/327
|
0.00%
0/328
|
0.30%
1/328
|
0.60%
2/332
|
|
Gastrointestinal disorders
Gastrointestinal Infection
|
0.31%
1/327
|
0.30%
1/328
|
0.61%
2/328
|
0.00%
0/332
|
|
Infections and infestations
Gingival Infection
|
0.00%
0/327
|
0.30%
1/328
|
0.00%
0/328
|
0.30%
1/332
|
|
Blood and lymphatic system disorders
Iron Deficiency Anemia
|
0.31%
1/327
|
0.00%
0/328
|
0.00%
0/328
|
0.00%
0/332
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/327
|
0.30%
1/328
|
0.00%
0/328
|
0.30%
1/332
|
|
Ear and labyrinth disorders
Ear Congestion
|
0.31%
1/327
|
0.00%
0/328
|
0.00%
0/328
|
0.00%
0/332
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/327
|
0.00%
0/328
|
0.00%
0/328
|
0.30%
1/332
|
|
Eye disorders
Blepharospasm
|
0.00%
0/327
|
0.00%
0/328
|
0.00%
0/328
|
0.30%
1/332
|
|
Eye disorders
Conjunctivitis
|
0.31%
1/327
|
0.00%
0/328
|
0.00%
0/328
|
0.00%
0/332
|
|
Eye disorders
Keratoconus
|
0.00%
0/327
|
0.00%
0/328
|
0.00%
0/328
|
0.30%
1/332
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/327
|
0.00%
0/328
|
0.00%
0/328
|
0.30%
1/332
|
|
Gastrointestinal disorders
Abdominal Hernia
|
0.00%
0/327
|
0.00%
0/328
|
0.00%
0/328
|
0.30%
1/332
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.31%
1/327
|
0.61%
2/328
|
0.30%
1/328
|
0.30%
1/332
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/327
|
0.00%
0/328
|
0.00%
0/328
|
0.30%
1/332
|
|
Gastrointestinal disorders
Dental Caries
|
0.31%
1/327
|
0.00%
0/328
|
0.00%
0/328
|
0.30%
1/332
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/327
|
0.61%
2/328
|
0.00%
0/328
|
0.00%
0/332
|
|
Gastrointestinal disorders
Dyspepsia
|
0.31%
1/327
|
0.00%
0/328
|
0.00%
0/328
|
0.30%
1/332
|
|
Gastrointestinal disorders
Gastritis
|
0.31%
1/327
|
0.00%
0/328
|
0.30%
1/328
|
0.00%
0/332
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
0.00%
0/327
|
0.00%
0/328
|
0.00%
0/328
|
0.30%
1/332
|
|
Gastrointestinal disorders
Hiatus Hernia
|
0.00%
0/327
|
0.00%
0/328
|
0.00%
0/328
|
0.30%
1/332
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/327
|
0.61%
2/328
|
0.00%
0/328
|
0.00%
0/332
|
|
Gastrointestinal disorders
Stomach Discomfort
|
0.61%
2/327
|
0.00%
0/328
|
0.00%
0/328
|
0.00%
0/332
|
|
Gastrointestinal disorders
Toothache
|
0.31%
1/327
|
0.30%
1/328
|
0.30%
1/328
|
0.30%
1/332
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/327
|
0.30%
1/328
|
0.00%
0/328
|
0.30%
1/332
|
|
General disorders
Application Site Dermatitis
|
0.61%
2/327
|
0.00%
0/328
|
0.00%
0/328
|
0.00%
0/332
|
|
General disorders
Application Site Dryness
|
0.00%
0/327
|
0.00%
0/328
|
0.30%
1/328
|
0.30%
1/332
|
|
General disorders
Application Site Eczema
|
0.00%
0/327
|
0.00%
0/328
|
0.30%
1/328
|
0.00%
0/332
|
|
General disorders
Application Site Erythema
|
0.00%
0/327
|
0.00%
0/328
|
0.30%
1/328
|
0.00%
0/332
|
|
General disorders
Application Site Hypersensitivity
|
0.00%
0/327
|
0.00%
0/328
|
0.30%
1/328
|
0.00%
0/332
|
|
General disorders
Application Site Irritation
|
0.31%
1/327
|
0.00%
0/328
|
0.61%
2/328
|
0.00%
0/332
|
|
General disorders
Application Site Pain
|
0.00%
0/327
|
0.30%
1/328
|
0.00%
0/328
|
0.00%
0/332
|
|
General disorders
Application Site Photosensitivity Reaction
|
0.61%
2/327
|
0.30%
1/328
|
0.30%
1/328
|
0.60%
2/332
|
|
General disorders
Application Site Pruritus
|
0.00%
0/327
|
0.30%
1/328
|
0.30%
1/328
|
0.30%
1/332
|
|
General disorders
Application Site Rash
|
0.00%
0/327
|
0.00%
0/328
|
0.30%
1/328
|
0.00%
0/332
|
|
General disorders
Drug Intolerance
|
0.00%
0/327
|
0.00%
0/328
|
0.30%
1/328
|
0.00%
0/332
|
|
General disorders
Influenza Like Illness
|
0.00%
0/327
|
0.30%
1/328
|
0.00%
0/328
|
0.30%
1/332
|
|
General disorders
Mass
|
0.31%
1/327
|
0.00%
0/328
|
0.00%
0/328
|
0.00%
0/332
|
|
General disorders
Pyrexia
|
0.31%
1/327
|
0.30%
1/328
|
0.00%
0/328
|
0.60%
2/332
|
|
Hepatobiliary disorders
Hepatic Cyst
|
0.00%
0/327
|
0.00%
0/328
|
0.00%
0/328
|
0.30%
1/332
|
|
Immune system disorders
Seasonal Allergy
|
0.00%
0/327
|
0.00%
0/328
|
0.61%
2/328
|
0.00%
0/332
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/327
|
0.00%
0/328
|
0.00%
0/328
|
0.30%
1/332
|
|
Infections and infestations
Alveolar Osteitis
|
0.31%
1/327
|
0.00%
0/328
|
0.00%
0/328
|
0.00%
0/332
|
|
Infections and infestations
Arthritis Infective
|
0.00%
0/327
|
0.30%
1/328
|
0.00%
0/328
|
0.00%
0/332
|
|
Infections and infestations
Herpes Zoster
|
0.31%
1/327
|
0.00%
0/328
|
0.00%
0/328
|
0.00%
0/332
|
|
Infections and infestations
Impetigo
|
0.00%
0/327
|
0.30%
1/328
|
0.00%
0/328
|
0.00%
0/332
|
|
Infections and infestations
Infectious Mononucleosis
|
0.00%
0/327
|
0.00%
0/328
|
0.00%
0/328
|
0.30%
1/332
|
|
Infections and infestations
Influenza
|
0.92%
3/327
|
1.5%
5/328
|
0.30%
1/328
|
1.2%
4/332
|
|
Infections and infestations
Laryngitis
|
0.00%
0/327
|
0.00%
0/328
|
0.30%
1/328
|
0.00%
0/332
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.00%
0/327
|
0.00%
0/328
|
0.30%
1/328
|
0.00%
0/332
|
|
Infections and infestations
Nasopharyngitis
|
8.3%
27/327
|
7.0%
23/328
|
9.8%
32/328
|
5.7%
19/332
|
|
Infections and infestations
Oral Candidiasis
|
0.31%
1/327
|
0.00%
0/328
|
0.00%
0/328
|
0.00%
0/332
|
|
Infections and infestations
Otitis Externa
|
0.31%
1/327
|
0.00%
0/328
|
0.30%
1/328
|
0.00%
0/332
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/327
|
0.30%
1/328
|
0.61%
2/328
|
0.00%
0/332
|
|
Infections and infestations
Pharyngitis Streptococcal
|
0.00%
0/327
|
0.30%
1/328
|
0.00%
0/328
|
0.60%
2/332
|
|
Infections and infestations
Pneumonia
|
0.00%
0/327
|
0.00%
0/328
|
0.00%
0/328
|
0.30%
1/332
|
|
Infections and infestations
Respiratory Tract Infection
|
0.00%
0/327
|
0.00%
0/328
|
0.00%
0/328
|
0.30%
1/332
|
|
Infections and infestations
Rhinitis
|
0.00%
0/327
|
0.61%
2/328
|
0.00%
0/328
|
0.30%
1/332
|
|
Infections and infestations
Sinusitis
|
0.61%
2/327
|
0.61%
2/328
|
0.61%
2/328
|
0.60%
2/332
|
|
Infections and infestations
Staphylococcal Infection
|
0.31%
1/327
|
0.00%
0/328
|
0.00%
0/328
|
0.00%
0/332
|
|
Infections and infestations
Tinea Infection
|
0.00%
0/327
|
0.00%
0/328
|
0.00%
0/328
|
0.30%
1/332
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/327
|
0.00%
0/328
|
0.00%
0/328
|
0.30%
1/332
|
|
Infections and infestations
Tooth Abscess
|
0.31%
1/327
|
0.00%
0/328
|
0.00%
0/328
|
0.30%
1/332
|
|
Infections and infestations
Tooth Infection
|
0.31%
1/327
|
0.00%
0/328
|
0.30%
1/328
|
0.00%
0/332
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
3.4%
11/327
|
4.0%
13/328
|
4.0%
13/328
|
3.9%
13/332
|
|
Infections and infestations
Urinary Tract Infection
|
0.31%
1/327
|
0.61%
2/328
|
0.30%
1/328
|
0.60%
2/332
|
|
Infections and infestations
Vaginal Infection
|
0.00%
0/327
|
0.30%
1/328
|
0.00%
0/328
|
0.30%
1/332
|
|
Infections and infestations
Varicella
|
0.00%
0/327
|
0.00%
0/328
|
0.00%
0/328
|
0.30%
1/332
|
|
Infections and infestations
Viral Infection
|
0.31%
1/327
|
0.00%
0/328
|
0.00%
0/328
|
0.30%
1/332
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
0.00%
0/327
|
0.00%
0/328
|
0.00%
0/328
|
0.30%
1/332
|
|
Infections and infestations
Vulvovaginal Mycotic Infection
|
0.00%
0/327
|
0.30%
1/328
|
0.00%
0/328
|
0.00%
0/332
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
0.00%
0/327
|
0.00%
0/328
|
0.00%
0/328
|
0.00%
0/332
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.31%
1/327
|
0.30%
1/328
|
0.61%
2/328
|
0.30%
1/332
|
|
Injury, poisoning and procedural complications
Fractured Coccyx
|
0.00%
0/327
|
0.30%
1/328
|
0.00%
0/328
|
0.00%
0/332
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.00%
0/327
|
0.30%
1/328
|
0.00%
0/328
|
0.00%
0/332
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/327
|
0.00%
0/328
|
0.00%
0/328
|
0.00%
0/332
|
|
Injury, poisoning and procedural complications
Joint Sprain
|
0.00%
0/327
|
0.61%
2/328
|
1.5%
5/328
|
0.00%
0/332
|
|
Injury, poisoning and procedural complications
Limb Crushing Injury
|
0.31%
1/327
|
0.00%
0/328
|
0.00%
0/328
|
0.00%
0/332
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
0.00%
0/327
|
0.30%
1/328
|
0.00%
0/328
|
0.30%
1/332
|
|
Injury, poisoning and procedural complications
Neck Injury
|
0.00%
0/327
|
0.00%
0/328
|
0.30%
1/328
|
0.00%
0/332
|
|
Injury, poisoning and procedural complications
Post-Traumatic Pain
|
0.31%
1/327
|
0.00%
0/328
|
0.00%
0/328
|
0.00%
0/332
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.61%
2/327
|
0.30%
1/328
|
0.00%
0/328
|
0.60%
2/332
|
|
Injury, poisoning and procedural complications
Radius Fracture
|
0.31%
1/327
|
0.00%
0/328
|
0.00%
0/328
|
0.00%
0/332
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.00%
0/327
|
0.61%
2/328
|
0.30%
1/328
|
0.30%
1/332
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.61%
2/327
|
1.5%
5/328
|
0.30%
1/328
|
0.60%
2/332
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
0.31%
1/327
|
0.00%
0/328
|
0.00%
0/328
|
0.00%
0/332
|
|
Injury, poisoning and procedural complications
Upper Limb Fracture
|
0.00%
0/327
|
0.00%
0/328
|
0.61%
2/328
|
0.00%
0/332
|
|
Injury, poisoning and procedural complications
Wrist Fracture
|
0.00%
0/327
|
0.00%
0/328
|
0.30%
1/328
|
0.00%
0/332
|
|
Investigations
Blood Testosterone Increased
|
0.00%
0/327
|
0.00%
0/328
|
0.30%
1/328
|
0.00%
0/332
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.31%
1/327
|
0.00%
0/328
|
0.00%
0/328
|
0.00%
0/332
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.61%
2/327
|
0.30%
1/328
|
0.00%
0/328
|
0.00%
0/332
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
0.00%
0/327
|
0.00%
0/328
|
0.30%
1/328
|
0.00%
0/332
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.31%
1/327
|
0.00%
0/328
|
0.00%
0/328
|
0.00%
0/332
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic Naevus
|
0.00%
0/327
|
0.30%
1/328
|
0.00%
0/328
|
0.00%
0/332
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin Papilloma
|
0.31%
1/327
|
0.00%
0/328
|
0.30%
1/328
|
0.00%
0/332
|
|
Nervous system disorders
Convulsion
|
0.00%
0/327
|
0.00%
0/328
|
0.00%
0/328
|
0.30%
1/332
|
|
Nervous system disorders
Dizziness
|
0.00%
0/327
|
0.30%
1/328
|
0.00%
0/328
|
0.00%
0/332
|
|
Nervous system disorders
Headache
|
1.2%
4/327
|
2.4%
8/328
|
2.7%
9/328
|
2.1%
7/332
|
|
Nervous system disorders
Migraine
|
0.31%
1/327
|
0.00%
0/328
|
0.00%
0/328
|
0.00%
0/332
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/327
|
0.00%
0/328
|
0.30%
1/328
|
0.00%
0/332
|
|
Nervous system disorders
Sinus Headache
|
0.00%
0/327
|
0.30%
1/328
|
0.00%
0/328
|
0.00%
0/332
|
|
Nervous system disorders
Syncope
|
0.00%
0/327
|
0.00%
0/328
|
0.30%
1/328
|
0.00%
0/332
|
|
Nervous system disorders
Tremor
|
0.00%
0/327
|
0.00%
0/328
|
0.00%
0/328
|
0.30%
1/332
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/327
|
0.00%
0/328
|
0.30%
1/328
|
0.00%
0/332
|
|
Psychiatric disorders
Attention Deficit/Hyperactivity Disorder
|
0.00%
0/327
|
0.00%
0/328
|
0.00%
0/328
|
0.30%
1/332
|
|
Psychiatric disorders
Depression
|
0.31%
1/327
|
0.00%
0/328
|
0.30%
1/328
|
0.00%
0/332
|
|
Psychiatric disorders
Nephrolithiasis
|
0.00%
0/327
|
0.00%
0/328
|
0.30%
1/328
|
0.00%
0/332
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/327
|
0.30%
1/328
|
0.00%
0/328
|
0.00%
0/332
|
|
Reproductive system and breast disorders
Adnexa Uteri Pain
|
0.00%
0/327
|
0.00%
0/328
|
0.00%
0/328
|
0.30%
1/332
|
|
Reproductive system and breast disorders
Breast Cyst
|
0.00%
0/327
|
0.30%
1/328
|
0.00%
0/328
|
0.00%
0/332
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.31%
1/327
|
0.00%
0/328
|
0.30%
1/328
|
0.60%
2/332
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/327
|
0.30%
1/328
|
0.00%
0/328
|
0.00%
0/332
|
|
Reproductive system and breast disorders
Ovarian Cyst Ruptured
|
0.00%
0/327
|
0.00%
0/328
|
0.30%
1/328
|
0.00%
0/332
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.61%
2/327
|
0.00%
0/328
|
0.30%
1/328
|
0.60%
2/332
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/327
|
0.30%
1/328
|
0.00%
0/328
|
0.00%
0/332
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.31%
1/327
|
0.30%
1/328
|
0.61%
2/328
|
0.00%
0/332
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
0.92%
3/327
|
0.00%
0/328
|
0.61%
2/328
|
0.60%
2/332
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Tract Congestion
|
0.00%
0/327
|
0.00%
0/328
|
0.30%
1/328
|
0.00%
0/332
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
0.00%
0/327
|
0.00%
0/328
|
0.00%
0/328
|
0.30%
1/332
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/327
|
0.00%
0/328
|
0.00%
0/328
|
0.30%
1/332
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
0.31%
1/327
|
0.00%
0/328
|
0.30%
1/328
|
0.30%
1/332
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/327
|
0.30%
1/328
|
0.30%
1/328
|
0.30%
1/332
|
|
Skin and subcutaneous tissue disorders
Chloasma
|
0.00%
0/327
|
0.00%
0/328
|
0.30%
1/328
|
0.00%
0/332
|
|
Skin and subcutaneous tissue disorders
Dermatitis Atopic
|
0.00%
0/327
|
0.30%
1/328
|
0.00%
0/328
|
0.00%
0/332
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
0.31%
1/327
|
0.30%
1/328
|
0.00%
0/328
|
0.30%
1/332
|
|
Skin and subcutaneous tissue disorders
Ingrowing Nail
|
0.00%
0/327
|
0.00%
0/328
|
0.00%
0/328
|
0.30%
1/332
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/327
|
0.00%
0/328
|
0.30%
1/328
|
0.30%
1/332
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/327
|
0.30%
1/328
|
0.00%
0/328
|
0.00%
0/332
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/327
|
0.00%
0/328
|
0.61%
2/328
|
0.00%
0/332
|
|
Surgical and medical procedures
Elective Surgery
|
0.00%
0/327
|
0.00%
0/328
|
0.30%
1/328
|
0.00%
0/332
|
|
Surgical and medical procedures
Mole Excision
|
0.31%
1/327
|
0.00%
0/328
|
0.00%
0/328
|
0.00%
0/332
|
|
Surgical and medical procedures
Tooth Extraction
|
0.00%
0/327
|
0.00%
0/328
|
0.00%
0/328
|
0.30%
1/332
|
|
Surgical and medical procedures
Wisdom Teeth Removal
|
0.31%
1/327
|
0.00%
0/328
|
0.61%
2/328
|
0.60%
2/332
|
|
Vascular disorders
Hypertension
|
0.00%
0/327
|
0.00%
0/328
|
0.30%
1/328
|
0.00%
0/332
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER