Trial Outcomes & Findings for DUAC® Early Onset Efficacy Study in Japanese Subjects (NCT NCT02557399)
NCT ID: NCT02557399
Last Updated: 2018-08-20
Results Overview
The assessor performed a count of IL (papules, pustules, nodular lesions), non-ILs (open and closed comedones) and total lesions (the sum of IL and non-IL) at each study visit. Lesion counts were confined to the face. Change from Baseline was calculated as the value at endpoint minus the value at Baseline. Data for adjusted mean has been reported. Percent change from Baseline is the change from Baseline divided by Baseline value multiplied by 100. The Baseline value was the latest pre-dose assessment value. The non-inflammatory lesions were counted by diagnosis based on palpation of the investigator (or sub-investigator).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
350 participants
Primary outcome timeframe
Baseline (Day 1) and Week 2
Results posted on
2018-08-20
Participant Flow
DUAC® (clindamycin phosphate 1.2 percent \[%\] + benzoyl peroxide 3%) is the registered product of GlaxoSmithKline. This study was conducted between 07 October 2015 and 17 February 2016 in which 349 participants were randomized.
Participant milestones
| Measure |
DUAC
Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 finger tip unit (FTU) about 0.6 gram (g) which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
|
ADA 0.1% +CLDM 1%
Participants were instructed to use combination therapy of Adapalene (ADA) 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and clindamycin (CLDM) 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to inflammatory lesions (ILs) only.
|
|---|---|---|
|
Overall Study
STARTED
|
172
|
177
|
|
Overall Study
COMPLETED
|
165
|
169
|
|
Overall Study
NOT COMPLETED
|
7
|
8
|
Reasons for withdrawal
| Measure |
DUAC
Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 finger tip unit (FTU) about 0.6 gram (g) which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
|
ADA 0.1% +CLDM 1%
Participants were instructed to use combination therapy of Adapalene (ADA) 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and clindamycin (CLDM) 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to inflammatory lesions (ILs) only.
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
5
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Protocol-defined stopping criteria
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
DUAC® Early Onset Efficacy Study in Japanese Subjects
Baseline characteristics by cohort
| Measure |
DUAC
n=172 Participants
Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity equal to about 0.6 g which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
|
ADA 0.1% +CLDM 1%
n=177 Participants
Participants were instructed to use combination therapy of ADA 0.1% gel with quantity equal to about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.
|
Total
n=349 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
20.3 Years
STANDARD_DEVIATION 5.91 • n=99 Participants
|
19.8 Years
STANDARD_DEVIATION 4.90 • n=107 Participants
|
20.0 Years
STANDARD_DEVIATION 5.42 • n=206 Participants
|
|
Sex: Female, Male
Female
|
97 Participants
n=99 Participants
|
110 Participants
n=107 Participants
|
207 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=99 Participants
|
67 Participants
n=107 Participants
|
142 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
172 Participants
n=99 Participants
|
177 Participants
n=107 Participants
|
349 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and Week 2Population: Intent-to-Treat (ITT) population comprised of all randomized participants who received at least one application of study product. Only those participants with data available at the indicated time points were analyzed
The assessor performed a count of IL (papules, pustules, nodular lesions), non-ILs (open and closed comedones) and total lesions (the sum of IL and non-IL) at each study visit. Lesion counts were confined to the face. Change from Baseline was calculated as the value at endpoint minus the value at Baseline. Data for adjusted mean has been reported. Percent change from Baseline is the change from Baseline divided by Baseline value multiplied by 100. The Baseline value was the latest pre-dose assessment value. The non-inflammatory lesions were counted by diagnosis based on palpation of the investigator (or sub-investigator).
Outcome measures
| Measure |
DUAC
n=169 Participants
Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 gram (g) which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
|
ADA 0.1% +CLDM 1%
n=176 Participants
Participants were instructed to use combination therapy of ADA 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.
|
|---|---|---|
|
Percent Change in Total Lesion Counts (TLs) From Baseline to Week 2
|
-42.16 Percent change in lesions
Standard Error 1.890
|
-35.33 Percent change in lesions
Standard Error 1.850
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 1, 4, 8, 12Population: ITT population. Only those participants with data available at the specified time points were analyzed.
The assessor performed a count of IL (papules, pustules, nodular lesions), non-ILs (open and closed comedones) and total lesions (the sum of IL and non-IL) at each study visit. Lesion counts were confined to the face. Change from Baseline was calculated as the value at endpoint minus the value at Baseline. Data for adjusted mean has been reported. Percent change from Baseline is the change from Baseline divided by Baseline value multiplied by 100. The Baseline value was the latest pre-dose assessment value. The non-ILs were counted by diagnosis based on palpation of the investigator (or sub-investigator). A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.
Outcome measures
| Measure |
DUAC
n=172 Participants
Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 gram (g) which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
|
ADA 0.1% +CLDM 1%
n=177 Participants
Participants were instructed to use combination therapy of ADA 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.
|
|---|---|---|
|
Percent Change From Baseline in TLs to Weeks 1, 4, 8 and 12
Week 1
|
-24.58 Percent change in lesions
Standard Error 1.729
|
-24.33 Percent change in lesions
Standard Error 1.697
|
|
Percent Change From Baseline in TLs to Weeks 1, 4, 8 and 12
Week 4
|
-55.51 Percent change in lesions
Standard Error 1.670
|
-49.65 Percent change in lesions
Standard Error 1.637
|
|
Percent Change From Baseline in TLs to Weeks 1, 4, 8 and 12
Week 8
|
-65.23 Percent change in lesions
Standard Error 1.544
|
-62.88 Percent change in lesions
Standard Error 1.514
|
|
Percent Change From Baseline in TLs to Weeks 1, 4, 8 and 12
Week 12
|
-74.60 Percent change in lesions
Standard Error 1.314
|
-71.36 Percent change in lesions
Standard Error 1.288
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 1, 2, 4, 8, 12Population: ITT population. Only those participants with data available at the specified time points were analyzed.
The assessor performed a count of IL (papules, pustules, nodular lesions), non-ILs (open and closed comedones). Lesion counts were confined to the face. Change from Baseline was calculated as the value at endpoint minus the value at Baseline. Data for adjusted mean has been reported. Percent change from Baseline is the change from Baseline divided by Baseline value multiplied by 100. The Baseline value was the latest pre-dose assessment value. The non-ILs were counted by diagnosis based on palpation of the investigator (or sub-investigator).
Outcome measures
| Measure |
DUAC
n=172 Participants
Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 gram (g) which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
|
ADA 0.1% +CLDM 1%
n=177 Participants
Participants were instructed to use combination therapy of ADA 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.
|
|---|---|---|
|
Percent Change Form Baseline in Lesion Counts (ILs and Non-ILs) to Weeks 1, 2, 4, 8 and 12
Week 1 ILs
|
-42.97 Percent change in lesions
Standard Error 2.349
|
-37.89 Percent change in lesions
Standard Error 2.309
|
|
Percent Change Form Baseline in Lesion Counts (ILs and Non-ILs) to Weeks 1, 2, 4, 8 and 12
Week 2 ILs
|
-60.92 Percent change in lesions
Standard Error 2.209
|
-52.49 Percent change in lesions
Standard Error 2.162
|
|
Percent Change Form Baseline in Lesion Counts (ILs and Non-ILs) to Weeks 1, 2, 4, 8 and 12
Week 4 ILs
|
-70.68 Percent change in lesions
Standard Error 1.898
|
-61.30 Percent change in lesions
Standard Error 1.860
|
|
Percent Change Form Baseline in Lesion Counts (ILs and Non-ILs) to Weeks 1, 2, 4, 8 and 12
Week 8 ILs
|
-76.33 Percent change in lesions
Standard Error 1.717
|
-69.64 Percent change in lesions
Standard Error 1.682
|
|
Percent Change Form Baseline in Lesion Counts (ILs and Non-ILs) to Weeks 1, 2, 4, 8 and 12
Week 12 ILs
|
-82.07 Percent change in lesions
Standard Error 1.403
|
-77.58 Percent change in lesions
Standard Error 1.374
|
|
Percent Change Form Baseline in Lesion Counts (ILs and Non-ILs) to Weeks 1, 2, 4, 8 and 12
Week 1 non-ILs
|
-15.13 Percent change in lesions
Standard Error 2.279
|
-17.85 Percent change in lesions
Standard Error 2.239
|
|
Percent Change Form Baseline in Lesion Counts (ILs and Non-ILs) to Weeks 1, 2, 4, 8 and 12
Week 2 non-ILs
|
-32.71 Percent change in lesions
Standard Error 2.419
|
-27.01 Percent change in lesions
Standard Error 2.367
|
|
Percent Change Form Baseline in Lesion Counts (ILs and Non-ILs) to Weeks 1, 2, 4, 8 and 12
Week 4 non-ILs
|
-47.64 Percent change in lesions
Standard Error 2.171
|
-43.74 Percent change in lesions
Standard Error 2.129
|
|
Percent Change Form Baseline in Lesion Counts (ILs and Non-ILs) to Weeks 1, 2, 4, 8 and 12
Week 8 non-ILs
|
-59.50 Percent change in lesions
Standard Error 1.910
|
-58.91 Percent change in lesions
Standard Error 1.872
|
|
Percent Change Form Baseline in Lesion Counts (ILs and Non-ILs) to Weeks 1, 2, 4, 8 and 12
Week 12 non-ILs
|
-71.07 Percent change in lesions
Standard Error 1.603
|
-67.29 Percent change in lesions
Standard Error 1.571
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 1, 2, 4, 8, 12Population: ITT population. Only those participants with data available at the specified time points were analyzed.
The assessor performed a count of IL (papules, pustules, nodular lesions), non-ILs (open and closed comedones) and total lesions (the sum of IL and non-IL) at each study visit. Lesion counts were confined to the face. Change from Baseline was calculated as the value at endpoint minus the value at Baseline. Data for adjusted mean has been reported. The non-ILs were counted by diagnosis based on palpation of the investigator (or sub-investigator). A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM. The Baseline value was the latest pre-dose assessment value.
Outcome measures
| Measure |
DUAC
n=172 Participants
Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 gram (g) which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
|
ADA 0.1% +CLDM 1%
n=177 Participants
Participants were instructed to use combination therapy of ADA 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.
|
|---|---|---|
|
Absolute Change From Baseline in Lesion Counts (TLs, ILs and Non-ILs) to Weeks 1, 2, 4, 8 and 12
Week 12 TLs
|
-76.2 lesion count
Standard Error 1.37
|
-74.5 lesion count
Standard Error 1.34
|
|
Absolute Change From Baseline in Lesion Counts (TLs, ILs and Non-ILs) to Weeks 1, 2, 4, 8 and 12
Week 1 ILs
|
-13.3 lesion count
Standard Error 0.74
|
-11.5 lesion count
Standard Error 0.72
|
|
Absolute Change From Baseline in Lesion Counts (TLs, ILs and Non-ILs) to Weeks 1, 2, 4, 8 and 12
Week 2 ILs
|
-19.3 lesion count
Standard Error 0.70
|
-16.3 lesion count
Standard Error 0.68
|
|
Absolute Change From Baseline in Lesion Counts (TLs, ILs and Non-ILs) to Weeks 1, 2, 4, 8 and 12
Week 1 TLs
|
-24.4 lesion count
Standard Error 1.70
|
-24.3 lesion count
Standard Error 1.67
|
|
Absolute Change From Baseline in Lesion Counts (TLs, ILs and Non-ILs) to Weeks 1, 2, 4, 8 and 12
Week 2 TLs
|
-41.8 lesion count
Standard Error 1.88
|
-35.6 lesion count
Standard Error 1.84
|
|
Absolute Change From Baseline in Lesion Counts (TLs, ILs and Non-ILs) to Weeks 1, 2, 4, 8 and 12
Week 4 ILs
|
-22.4 lesion count
Standard Error 0.62
|
-19.8 lesion count
Standard Error 0.60
|
|
Absolute Change From Baseline in Lesion Counts (TLs, ILs and Non-ILs) to Weeks 1, 2, 4, 8 and 12
Week 4 TLs
|
-56.3 lesion count
Standard Error 1.71
|
-51.6 lesion count
Standard Error 1.67
|
|
Absolute Change From Baseline in Lesion Counts (TLs, ILs and Non-ILs) to Weeks 1, 2, 4, 8 and 12
Week 8 TLs
|
-66.4 lesion count
Standard Error 1.60
|
-65.7 lesion count
Standard Error 1.57
|
|
Absolute Change From Baseline in Lesion Counts (TLs, ILs and Non-ILs) to Weeks 1, 2, 4, 8 and 12
Week 1 non-ILs
|
-11.1 lesion count
Standard Error 1.46
|
-12.9 lesion count
Standard Error 1.43
|
|
Absolute Change From Baseline in Lesion Counts (TLs, ILs and Non-ILs) to Weeks 1, 2, 4, 8 and 12
Week 2 non-ILs
|
-22.5 lesion count
Standard Error 1.59
|
-19.3 lesion count
Standard Error 1.56
|
|
Absolute Change From Baseline in Lesion Counts (TLs, ILs and Non-ILs) to Weeks 1, 2, 4, 8 and 12
Week 4 non-ILs
|
-34.0 lesion count
Standard Error 1.46
|
-32.0 lesion count
Standard Error 1.44
|
|
Absolute Change From Baseline in Lesion Counts (TLs, ILs and Non-ILs) to Weeks 1, 2, 4, 8 and 12
Week 8 non-ILs
|
-42.2 lesion count
Standard Error 1.33
|
-43.4 lesion count
Standard Error 1.31
|
|
Absolute Change From Baseline in Lesion Counts (TLs, ILs and Non-ILs) to Weeks 1, 2, 4, 8 and 12
Week 12 non-ILs
|
-50.2 lesion count
Standard Error 1.11
|
-49.6 lesion count
Standard Error 1.09
|
|
Absolute Change From Baseline in Lesion Counts (TLs, ILs and Non-ILs) to Weeks 1, 2, 4, 8 and 12
Week 8 ILs
|
-24.3 lesion count
Standard Error 0.56
|
-22.4 lesion count
Standard Error 0.55
|
|
Absolute Change From Baseline in Lesion Counts (TLs, ILs and Non-ILs) to Weeks 1, 2, 4, 8 and 12
Week 12 ILs
|
-26.0 lesion count
Standard Error 0.48
|
-24.9 lesion count
Standard Error 0.47
|
SECONDARY outcome
Timeframe: Week 1, 2, 4, 8, 12Population: ITT population.
Responder was defined as participants with a minimum 2-grade improvement in ISGA score from Baseline. ISGA scale was scored from 0-5 (0= Clear skin with no inflammatory or non-ILs, 1= Almost clear: rare non-ILs present, with no more than rare papules, 2= Mild severity: greater than Grade 1, some non-ILs with no more than few inflammatory lesions, 3= Moderate severity: greater than Grade 2, many non-ILS, may have some ILs, but no more than 1 small nodular lesion, 4= Severe: greater than Grade 3, up to many non-ILs and ILs, but no more than a few nodular lesions, 5= Very severe: many non -ILs and ILs and more than a few nodular lesions. May have cystic lesions). Percentage of participants was calculated by dividing number of participants with 2-grade improvement in ISGA score from Baseline by total number of participants value multiplied by 100.
Outcome measures
| Measure |
DUAC
n=172 Participants
Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 gram (g) which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
|
ADA 0.1% +CLDM 1%
n=177 Participants
Participants were instructed to use combination therapy of ADA 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.
|
|---|---|---|
|
Percentage of Participants With a Minimum of 2-grade Improvement in Investigator's Static Global Assessment (ISGA) Score From Baseline to Weeks 1, 2, 4, 8 and 12
Week 1
|
2 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With a Minimum of 2-grade Improvement in Investigator's Static Global Assessment (ISGA) Score From Baseline to Weeks 1, 2, 4, 8 and 12
Week 2
|
6 Percentage of participants
|
3 Percentage of participants
|
|
Percentage of Participants With a Minimum of 2-grade Improvement in Investigator's Static Global Assessment (ISGA) Score From Baseline to Weeks 1, 2, 4, 8 and 12
Week 4
|
12 Percentage of participants
|
8 Percentage of participants
|
|
Percentage of Participants With a Minimum of 2-grade Improvement in Investigator's Static Global Assessment (ISGA) Score From Baseline to Weeks 1, 2, 4, 8 and 12
Week 8
|
22 Percentage of participants
|
12 Percentage of participants
|
|
Percentage of Participants With a Minimum of 2-grade Improvement in Investigator's Static Global Assessment (ISGA) Score From Baseline to Weeks 1, 2, 4, 8 and 12
Week 12
|
37 Percentage of participants
|
27 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 1, 2, 4, 8 and 12Population: ITT population.
Responder was defined as participant with ISGA score of 0 or 1. ISGA scale was scored from 0-5 (0= Clear skin with no inflammatory or non-ILs, 1= Almost clear: rare non-ILs present, with no more than rare papules, 2= Mild severity: greater than Grade 1, some non-ILs with no more than few inflammatory lesions, 3= Moderate severity: greater than Grade 2, many non-ILS, may have some ILs, but no more than 1 small nodular lesion, 4= Severe: greater than Grade 3, up to many non-ILs and ILs, but no more than a few nodular lesions, 5= Very severe: many non -ILs and ILs and more than a few nodular lesions. May have cystic lesions). Percentage of participants was calculated by dividing number of participants with 0-1 ISGA score post Baseline by total number of participants value multiplied by 100.
Outcome measures
| Measure |
DUAC
n=172 Participants
Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 gram (g) which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
|
ADA 0.1% +CLDM 1%
n=177 Participants
Participants were instructed to use combination therapy of ADA 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.
|
|---|---|---|
|
Percentage of Participants With ISGA Score of 0 or 1 at Weeks 1, 2, 4, 8 and 12
Week 1
|
2 Percentage of participants
|
1 Percentage of participants
|
|
Percentage of Participants With ISGA Score of 0 or 1 at Weeks 1, 2, 4, 8 and 12
Week 2
|
6 Percentage of participants
|
5 Percentage of participants
|
|
Percentage of Participants With ISGA Score of 0 or 1 at Weeks 1, 2, 4, 8 and 12
Week 4
|
13 Percentage of participants
|
6 Percentage of participants
|
|
Percentage of Participants With ISGA Score of 0 or 1 at Weeks 1, 2, 4, 8 and 12
Week 8
|
20 Percentage of participants
|
12 Percentage of participants
|
|
Percentage of Participants With ISGA Score of 0 or 1 at Weeks 1, 2, 4, 8 and 12
Week 12
|
41 Percentage of participants
|
29 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 1, 2, 4, 8 and 12Population: ITT population. Only those participants with data available at the specified time points were analyzed.
Responder was defined as participants with at least a 50% reduction in TLs, ILs and non-ILs. Data for number of participants is reported. Percentage of participants was calculated by dividing number of responders by total number of participants value multiplied by 100.
Outcome measures
| Measure |
DUAC
n=172 Participants
Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 gram (g) which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
|
ADA 0.1% +CLDM 1%
n=177 Participants
Participants were instructed to use combination therapy of ADA 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.
|
|---|---|---|
|
Percentage of Participants With at Least 50% Reduction in Lesion Counts (TLs, ILs and Non-ILs) From Baseline at Weeks 1, 2, 4, 8 and 12
Week 1 TLs
|
22 Percentage of participants
|
18 Percentage of participants
|
|
Percentage of Participants With at Least 50% Reduction in Lesion Counts (TLs, ILs and Non-ILs) From Baseline at Weeks 1, 2, 4, 8 and 12
Week 2 TLs
|
47 Percentage of participants
|
42 Percentage of participants
|
|
Percentage of Participants With at Least 50% Reduction in Lesion Counts (TLs, ILs and Non-ILs) From Baseline at Weeks 1, 2, 4, 8 and 12
Week 4 TLs
|
67 Percentage of participants
|
60 Percentage of participants
|
|
Percentage of Participants With at Least 50% Reduction in Lesion Counts (TLs, ILs and Non-ILs) From Baseline at Weeks 1, 2, 4, 8 and 12
Week 8 TLs
|
81 Percentage of participants
|
81 Percentage of participants
|
|
Percentage of Participants With at Least 50% Reduction in Lesion Counts (TLs, ILs and Non-ILs) From Baseline at Weeks 1, 2, 4, 8 and 12
Week 12 TLs
|
88 Percentage of participants
|
86 Percentage of participants
|
|
Percentage of Participants With at Least 50% Reduction in Lesion Counts (TLs, ILs and Non-ILs) From Baseline at Weeks 1, 2, 4, 8 and 12
Week 1 ILs
|
51 Percentage of participants
|
42 Percentage of participants
|
|
Percentage of Participants With at Least 50% Reduction in Lesion Counts (TLs, ILs and Non-ILs) From Baseline at Weeks 1, 2, 4, 8 and 12
Week 2 ILs
|
77 Percentage of participants
|
66 Percentage of participants
|
|
Percentage of Participants With at Least 50% Reduction in Lesion Counts (TLs, ILs and Non-ILs) From Baseline at Weeks 1, 2, 4, 8 and 12
Week 4 ILs
|
85 Percentage of participants
|
76 Percentage of participants
|
|
Percentage of Participants With at Least 50% Reduction in Lesion Counts (TLs, ILs and Non-ILs) From Baseline at Weeks 1, 2, 4, 8 and 12
Week 8 ILs
|
87 Percentage of participants
|
84 Percentage of participants
|
|
Percentage of Participants With at Least 50% Reduction in Lesion Counts (TLs, ILs and Non-ILs) From Baseline at Weeks 1, 2, 4, 8 and 12
Week 12 ILs
|
92 Percentage of participants
|
89 Percentage of participants
|
|
Percentage of Participants With at Least 50% Reduction in Lesion Counts (TLs, ILs and Non-ILs) From Baseline at Weeks 1, 2, 4, 8 and 12
Week 1 non-ILs
|
14 Percentage of participants
|
16 Percentage of participants
|
|
Percentage of Participants With at Least 50% Reduction in Lesion Counts (TLs, ILs and Non-ILs) From Baseline at Weeks 1, 2, 4, 8 and 12
Week 2 non-ILs
|
37 Percentage of participants
|
34 Percentage of participants
|
|
Percentage of Participants With at Least 50% Reduction in Lesion Counts (TLs, ILs and Non-ILs) From Baseline at Weeks 1, 2, 4, 8 and 12
Week 4 non-ILs
|
58 Percentage of participants
|
54 Percentage of participants
|
|
Percentage of Participants With at Least 50% Reduction in Lesion Counts (TLs, ILs and Non-ILs) From Baseline at Weeks 1, 2, 4, 8 and 12
Week 8 non-ILs
|
73 Percentage of participants
|
73 Percentage of participants
|
|
Percentage of Participants With at Least 50% Reduction in Lesion Counts (TLs, ILs and Non-ILs) From Baseline at Weeks 1, 2, 4, 8 and 12
Week 12 non-ILs
|
83 Percentage of participants
|
80 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 1, 2, 4, 8 and 12Population: ITT population.
The investigator (or sub-investigator), the product storage manager, or the blinded coordinator dispensed a study compliance log to record participant's compliance with investigational product application from Baseline to the end of study treatment. The product storage manager or the blinded coordinator evaluated the participant's compliance with study treatment, using the study compliance log at each visit, and recorded the compliance data in the eCRF.
Outcome measures
| Measure |
DUAC
n=172 Participants
Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 gram (g) which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
|
ADA 0.1% +CLDM 1%
n=177 Participants
Participants were instructed to use combination therapy of ADA 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.
|
|---|---|---|
|
Number of Participants With Treatment Adherence Rate at Weeks 1, 2, 4, 8 and 12
week 1
|
143 Participants
|
131 Participants
|
|
Number of Participants With Treatment Adherence Rate at Weeks 1, 2, 4, 8 and 12
week 2
|
125 Participants
|
115 Participants
|
|
Number of Participants With Treatment Adherence Rate at Weeks 1, 2, 4, 8 and 12
week 4
|
110 Participants
|
85 Participants
|
|
Number of Participants With Treatment Adherence Rate at Weeks 1, 2, 4, 8 and 12
week 8
|
89 Participants
|
72 Participants
|
|
Number of Participants With Treatment Adherence Rate at Weeks 1, 2, 4, 8 and 12
week 12
|
88 Participants
|
63 Participants
|
SECONDARY outcome
Timeframe: Up to Week 12Population: ITT population.
Number of participants who continued the treatment till Week 12 was measured. Overall data for participants who have not missed any dose during the treatment period has been reported.
Outcome measures
| Measure |
DUAC
n=172 Participants
Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 gram (g) which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
|
ADA 0.1% +CLDM 1%
n=177 Participants
Participants were instructed to use combination therapy of ADA 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.
|
|---|---|---|
|
Number of Participants Who Continued Treatment at Weeks 1, 2, 4, 8 and 12
|
63 Participants
|
59 Participants
|
SECONDARY outcome
Timeframe: Week 1, 2, 4, 8 and 12Population: ITT population. Only those participants with data available at the specified time points were analyzed.
Participants had to rate each question on a 5-point scale of 0 to 4 (4: yes, very easy to use, 3: yes, easy, 2: slightly easy, 1: slightly difficult, 0: No) where larger score indicates more preferable participant's feeling. There were 5 questions in the questionnaire: ease of application, comfort, satisfaction with treatment (ST), comparison with prior therapies (CPT) and willingness to continue using the product (WCP).
Outcome measures
| Measure |
DUAC
n=172 Participants
Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 gram (g) which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
|
ADA 0.1% +CLDM 1%
n=177 Participants
Participants were instructed to use combination therapy of ADA 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.
|
|---|---|---|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 4: Comfort, Score 2
|
17 Participants
|
31 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 4: Comfort, Score 1
|
5 Participants
|
15 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 1: Ease of application, Score 4
|
131 Participants
|
95 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 1: Ease of application, Score 3
|
38 Participants
|
66 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 1: Ease of application, Score 2
|
2 Participants
|
13 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 1: Ease of application, Score 1
|
1 Participants
|
2 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 2: Ease of application, Score 4
|
128 Participants
|
83 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 2: Ease of application, Score 3
|
38 Participants
|
75 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 2: Ease of application, Score 2
|
2 Participants
|
17 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 2: Ease of application, Score 1
|
1 Participants
|
1 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 4: Ease of application, Score 4
|
118 Participants
|
85 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 4: Ease of application, Score 3
|
49 Participants
|
70 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 4: Ease of application, Score 2
|
2 Participants
|
18 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 4: Ease of application, Score 1
|
0 Participants
|
1 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 8: Ease of application, Score 4
|
114 Participants
|
90 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 8: Ease of application, Score 3
|
50 Participants
|
60 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 8: Ease of application, Score 2
|
3 Participants
|
19 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 8: Ease of application, Score 1
|
0 Participants
|
3 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 12: Ease of application, Score 4
|
116 Participants
|
81 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 12: Ease of application, Score 3
|
44 Participants
|
68 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 12: Ease of application, Score 2
|
4 Participants
|
18 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 12: Ease of application, Score 1
|
0 Participants
|
2 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 1: Comfort, Score 4
|
37 Participants
|
24 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 1: Comfort, Score 3
|
86 Participants
|
69 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 1: Comfort, Score 2
|
37 Participants
|
45 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 1: Comfort, Score 1
|
7 Participants
|
32 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 1: Comfort, Score 0
|
5 Participants
|
6 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 2: Comfort, Score 4
|
56 Participants
|
35 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 2: Comfort, Score 3
|
70 Participants
|
81 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 2: Comfort, Score 2
|
36 Participants
|
42 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 2: Comfort, Score 1
|
6 Participants
|
17 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 2: Comfort, Score 0
|
1 Participants
|
1 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 4: Comfort, Score 4
|
72 Participants
|
47 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 4: Comfort, Score 3
|
75 Participants
|
80 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 4: Comfort, Score 0
|
0 Participants
|
1 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 8: Comfort, Score 4
|
79 Participants
|
53 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 8: Comfort, Score 3
|
69 Participants
|
68 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 8: Comfort, Score 2
|
18 Participants
|
36 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 8: Comfort, Score 1
|
1 Participants
|
13 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 8: Comfort, Score 0
|
0 Participants
|
2 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 12: Comfort, Score 4
|
84 Participants
|
56 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 12: Comfort, Score 3
|
66 Participants
|
73 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 12: Comfort, Score 2
|
13 Participants
|
26 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 12: Comfort, Score 1
|
1 Participants
|
13 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 12: Comfort, Score 0
|
0 Participants
|
1 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 1: ST, Score 4
|
36 Participants
|
21 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 1: ST, Score 3
|
79 Participants
|
75 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 1: ST, Score 2
|
46 Participants
|
49 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 1: ST, Score 1
|
11 Participants
|
23 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 1: ST, Score 0
|
0 Participants
|
8 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 2: ST, Score 4
|
58 Participants
|
38 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 2: ST, Score 3
|
70 Participants
|
81 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 2: ST, Score 2
|
37 Participants
|
47 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 2: ST, Score 1
|
4 Participants
|
7 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 2: ST, Score 0
|
0 Participants
|
3 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 4: ST, Score 4
|
66 Participants
|
44 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 4: ST, Score 3
|
72 Participants
|
81 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 4: ST, Score 2
|
27 Participants
|
40 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 4: ST, Score 1
|
4 Participants
|
8 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 4: ST, Score 0
|
0 Participants
|
1 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 8: ST, Score 4
|
78 Participants
|
58 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 8: ST, Score 3
|
67 Participants
|
72 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 8: ST, Score 2
|
17 Participants
|
33 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 8: ST, Score 1
|
5 Participants
|
6 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 8: ST, Score 0
|
0 Participants
|
3 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 12: ST, Score 4
|
82 Participants
|
63 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 12: ST, Score 3
|
61 Participants
|
70 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 12: ST, Score 2
|
20 Participants
|
29 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 12: ST, Score 1
|
1 Participants
|
6 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 12: ST, Score 0
|
0 Participants
|
1 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 1: CPT, Score 4
|
77 Participants
|
53 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 1: CPT, Score 3
|
50 Participants
|
45 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 1: CPT, Score 2
|
38 Participants
|
61 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 1: CPT, Score 1
|
7 Participants
|
11 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 1: CPT, Score 0
|
0 Participants
|
6 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 2: CPT, Score 4,
|
90 Participants
|
57 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 2: CPT, Score 3
|
51 Participants
|
55 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 2: CPT, Score 2
|
25 Participants
|
54 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 2: CPT, Score 1
|
2 Participants
|
10 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 2: CPT, Score 0
|
1 Participants
|
0 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 4: CPT, Score 4
|
100 Participants
|
67 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 4: CPT, Score 3
|
47 Participants
|
52 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 4: CPT, Score 2
|
18 Participants
|
46 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 4: CPT, Score 1
|
4 Participants
|
8 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 4: CPT, Score 0
|
0 Participants
|
1 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 8: CPT, Score 4
|
109 Participants
|
73 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 8: CPT, Score 3
|
38 Participants
|
50 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 8: CPT, Score 2
|
19 Participants
|
40 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 8: CPT, Score 1
|
1 Participants
|
8 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 8: CPT, Score 0
|
0 Participants
|
1 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 12: CPT, Score 4
|
112 Participants
|
78 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 12: CPT, Score 3
|
42 Participants
|
47 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 12: CPT, Score 2
|
8 Participants
|
35 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 12: CPT, Score 1
|
2 Participants
|
7 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 12: CPT, Score 0
|
0 Participants
|
2 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 1: WCP, Score 4
|
64 Participants
|
36 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 1: WCP, Score 3
|
79 Participants
|
78 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 1: WCP, Score 2
|
25 Participants
|
39 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 1: WCP, Score 1
|
4 Participants
|
19 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 1: WCP, Score 0
|
0 Participants
|
4 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 2: WCP, Score 4
|
75 Participants
|
55 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 2: WCP, Score 3
|
72 Participants
|
70 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 2: WCP, Score 2
|
19 Participants
|
38 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 2: WCP, Score 1
|
3 Participants
|
13 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 4: WCP, Score 4
|
88 Participants
|
63 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 4: WCP, Score 3
|
63 Participants
|
75 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 4: WCP, Score 2
|
15 Participants
|
26 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 4: WCP, Score 1
|
3 Participants
|
10 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 8: WCP, Score 4
|
90 Participants
|
62 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 8: WCP, Score 3
|
59 Participants
|
74 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 8: WCP, Score 2
|
15 Participants
|
27 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 8: WCP, Score 1
|
3 Participants
|
9 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 12: WCP, Score 4
|
94 Participants
|
70 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 12: WCP, Score 3
|
56 Participants
|
65 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 12: WCP, Score 2
|
12 Participants
|
23 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 12: WCP, Score 1
|
1 Participants
|
11 Participants
|
|
Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Week 12: WCP, Score 0
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline(Day 1) and Week 2, 4, 8 and 12Population: ITT population. Only those participants with data available at the specified time points were analyzed.
QOL questionnaire was assessed using Skindex-16 with 16 questions in 3 multi-item scales: symptoms, emotions and functioning for the past week: skin condition-itching, burning or stinging, hurting, being irritated, persistence/reoccurrence of skin condition, worry about condition, appearance of skin, frustration about skin, embarrassment about skin, being annoyed about your skin, feeling depressed about skin, effects of your skin on your interactions with others, effects of your skin condition on your desire to be with people, skin condition making it hard to show affection, effects of your skin condition on your daily activities and skin condition making it hard to work or do what you enjoy. Data for adjusted mean has been reported. The Baseline value was the latest pre-dose assessment value. Change from Baseline was calculated as the value at endpoint minus the value at Baseline. Scores range from 0-never bothered to 100-always bothered.
Outcome measures
| Measure |
DUAC
n=172 Participants
Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 gram (g) which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
|
ADA 0.1% +CLDM 1%
n=177 Participants
Participants were instructed to use combination therapy of ADA 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.
|
|---|---|---|
|
Change From Baseline in Quality of Life (QoL) Score at Week 2, 4, 8 and 12
Week 2
|
-0.71 Score on scale
Standard Error 0.070
|
-0.49 Score on scale
Standard Error 0.068
|
|
Change From Baseline in Quality of Life (QoL) Score at Week 2, 4, 8 and 12
Week 4
|
-1.02 Score on scale
Standard Error 0.069
|
-0.80 Score on scale
Standard Error 0.068
|
|
Change From Baseline in Quality of Life (QoL) Score at Week 2, 4, 8 and 12
Week 8
|
-1.14 Score on scale
Standard Error 0.073
|
-0.92 Score on scale
Standard Error 0.071
|
|
Change From Baseline in Quality of Life (QoL) Score at Week 2, 4, 8 and 12
Week 12
|
-1.27 Score on scale
Standard Error 0.073
|
-1.10 Score on scale
Standard Error 0.072
|
SECONDARY outcome
Timeframe: Up to Week 12Population: ITT population.
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate. For liver injury and impaired liver function, alanine aminotransferase greater than or equal to (\>=)3 times upper limit of normal (ULN) and total bilirubin \>=2xULN (less than \[\>\] 35% direct) was defined.
Outcome measures
| Measure |
DUAC
n=172 Participants
Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 gram (g) which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
|
ADA 0.1% +CLDM 1%
n=177 Participants
Participants were instructed to use combination therapy of ADA 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.
|
|---|---|---|
|
Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any AE
|
53 Participants
|
100 Participants
|
|
Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any SAE
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 1, 2, 4, 8 and 12Population: ITT population. Only those participants with data available at the specified time points were analyzed.
Local tolerability score for erythema (no redness, faint red or pink coloration, barely perceptible, light red or pink coloration, medium red coloration, beet red coloration), dryness (none, barely perceptible dryness with no flakes or fissure formation, easily perceptible dryness with no flakes or fissure formation, easily noted dryness and flakes but no fissure formation, easily noted dryness with flakes and fissure formation), peeling (no peeling, mild localized peeling, mild and diffuse peeling, moderate and diffuse peeling, moderate to prominent, dense peeling) and itching and burning/stinging (normal-no discomfort, noticeable discomfort that causes intermittent awareness, continuous awareness, intermittent awareness and interferes occasionally with normal daily activities, a definite continuous discomfort that interferes with normal daily activities) was assessed on a scale of 0 to 4 (0= absent, 1= slight, 2= mild, 3= moderate and 4= severe).
Outcome measures
| Measure |
DUAC
n=172 Participants
Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 gram (g) which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
|
ADA 0.1% +CLDM 1%
n=177 Participants
Participants were instructed to use combination therapy of ADA 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.
|
|---|---|---|
|
Local Tolerability Score for Erythema, Dryness, Peeling, Itching, and Burning or Stinging
Erythema Week 1
|
0.0 Score on scale
Standard Deviation 0.61
|
0.3 Score on scale
Standard Deviation 0.72
|
|
Local Tolerability Score for Erythema, Dryness, Peeling, Itching, and Burning or Stinging
Erythema Week 2
|
0.0 Score on scale
Standard Deviation 0.68
|
0.0 Score on scale
Standard Deviation 0.70
|
|
Local Tolerability Score for Erythema, Dryness, Peeling, Itching, and Burning or Stinging
Erythema Week 4
|
-0.1 Score on scale
Standard Deviation 0.57
|
-0.1 Score on scale
Standard Deviation 0.64
|
|
Local Tolerability Score for Erythema, Dryness, Peeling, Itching, and Burning or Stinging
Erythema Week 8
|
-0.2 Score on scale
Standard Deviation 0.68
|
-0.2 Score on scale
Standard Deviation 0.69
|
|
Local Tolerability Score for Erythema, Dryness, Peeling, Itching, and Burning or Stinging
Erythema Week 12
|
-0.2 Score on scale
Standard Deviation 0.78
|
-0.3 Score on scale
Standard Deviation 0.67
|
|
Local Tolerability Score for Erythema, Dryness, Peeling, Itching, and Burning or Stinging
Dryness Week 1
|
0.1 Score on scale
Standard Deviation 0.54
|
0.6 Score on scale
Standard Deviation 0.95
|
|
Local Tolerability Score for Erythema, Dryness, Peeling, Itching, and Burning or Stinging
Dryness Week 2
|
0.0 Score on scale
Standard Deviation 0.50
|
0.1 Score on scale
Standard Deviation 0.58
|
|
Local Tolerability Score for Erythema, Dryness, Peeling, Itching, and Burning or Stinging
Dryness Week 4
|
0.0 Score on scale
Standard Deviation 0.52
|
0.1 Score on scale
Standard Deviation 0.49
|
|
Local Tolerability Score for Erythema, Dryness, Peeling, Itching, and Burning or Stinging
Dryness Week 8
|
0.0 Score on scale
Standard Deviation 0.58
|
0.1 Score on scale
Standard Deviation 0.46
|
|
Local Tolerability Score for Erythema, Dryness, Peeling, Itching, and Burning or Stinging
Dryness Week 12
|
0.0 Score on scale
Standard Deviation 0.45
|
0.0 Score on scale
Standard Deviation 0.35
|
|
Local Tolerability Score for Erythema, Dryness, Peeling, Itching, and Burning or Stinging
Peeling Week 1
|
0.1 Score on scale
Standard Deviation 0.43
|
0.5 Score on scale
Standard Deviation 0.88
|
|
Local Tolerability Score for Erythema, Dryness, Peeling, Itching, and Burning or Stinging
Peeling Week 2
|
0.1 Score on scale
Standard Deviation 0.33
|
0.2 Score on scale
Standard Deviation 0.55
|
|
Local Tolerability Score for Erythema, Dryness, Peeling, Itching, and Burning or Stinging
Peeling Week 4
|
0.0 Score on scale
Standard Deviation 0.34
|
0.1 Score on scale
Standard Deviation 0.42
|
|
Local Tolerability Score for Erythema, Dryness, Peeling, Itching, and Burning or Stinging
Peeling Week 8
|
0.1 Score on scale
Standard Deviation 0.39
|
0.1 Score on scale
Standard Deviation 0.46
|
|
Local Tolerability Score for Erythema, Dryness, Peeling, Itching, and Burning or Stinging
Peeling Week 12
|
0.0 Score on scale
Standard Deviation 0.31
|
0.0 Score on scale
Standard Deviation 0.32
|
|
Local Tolerability Score for Erythema, Dryness, Peeling, Itching, and Burning or Stinging
Itching Week 1
|
0.0 Score on scale
Standard Deviation 0.64
|
0.1 Score on scale
Standard Deviation 0.81
|
|
Local Tolerability Score for Erythema, Dryness, Peeling, Itching, and Burning or Stinging
Itching Week 2
|
0.0 Score on scale
Standard Deviation 0.60
|
0.1 Score on scale
Standard Deviation 0.77
|
|
Local Tolerability Score for Erythema, Dryness, Peeling, Itching, and Burning or Stinging
Itching Week 4
|
-0.1 Score on scale
Standard Deviation 0.68
|
-0.1 Score on scale
Standard Deviation 0.62
|
|
Local Tolerability Score for Erythema, Dryness, Peeling, Itching, and Burning or Stinging
Itching Week 8
|
-0.2 Score on scale
Standard Deviation 0.63
|
-0.1 Score on scale
Standard Deviation 0.58
|
|
Local Tolerability Score for Erythema, Dryness, Peeling, Itching, and Burning or Stinging
Itching Week 12
|
-0.2 Score on scale
Standard Deviation 0.66
|
-0.2 Score on scale
Standard Deviation 0.56
|
|
Local Tolerability Score for Erythema, Dryness, Peeling, Itching, and Burning or Stinging
Burning/Stinging Week 1
|
0.0 Score on scale
Standard Deviation 0.48
|
0.5 Score on scale
Standard Deviation 0.85
|
|
Local Tolerability Score for Erythema, Dryness, Peeling, Itching, and Burning or Stinging
Burning/Stinging Week 2
|
0.0 Score on scale
Standard Deviation 0.44
|
0.2 Score on scale
Standard Deviation 0.66
|
|
Local Tolerability Score for Erythema, Dryness, Peeling, Itching, and Burning or Stinging
Burning/Stinging Week 4
|
0.0 Score on scale
Standard Deviation 0.44
|
0.0 Score on scale
Standard Deviation 0.47
|
|
Local Tolerability Score for Erythema, Dryness, Peeling, Itching, and Burning or Stinging
Burning/Stinging Week 8
|
0.0 Score on scale
Standard Deviation 0.34
|
0.1 Score on scale
Standard Deviation 0.53
|
|
Local Tolerability Score for Erythema, Dryness, Peeling, Itching, and Burning or Stinging
Burning/Stinging Week 12
|
0.0 Score on scale
Standard Deviation 0.39
|
0.0 Score on scale
Standard Deviation 0.40
|
SECONDARY outcome
Timeframe: Up to Week 12Population: ITT population.
The severity of AEs was assessed by the investigator; events were assigned to one of the following categories: mild, an event that was easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities; moderate, an event that was sufficiently discomforting to interfere with normal everyday activities; and severe, an event that prevented normal everyday activities.
Outcome measures
| Measure |
DUAC
n=172 Participants
Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 gram (g) which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
|
ADA 0.1% +CLDM 1%
n=177 Participants
Participants were instructed to use combination therapy of ADA 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.
|
|---|---|---|
|
Number of Participants With Severity of AEs
Mild
|
46 Participants
|
91 Participants
|
|
Number of Participants With Severity of AEs
Modertae
|
6 Participants
|
7 Participants
|
|
Number of Participants With Severity of AEs
Severe
|
1 Participants
|
2 Participants
|
Adverse Events
Duac
Serious events: 1 serious events
Other events: 34 other events
Deaths: 0 deaths
ADA 0.1% +CLDM 1%
Serious events: 0 serious events
Other events: 78 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Duac
n=172 participants at risk
Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 gram (g) which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
|
ADA 0.1% +CLDM 1%
n=177 participants at risk
Participants were instructed to use combination therapy of Adapalene (ADA) 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and clindamycin (CLDM) 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to inflammatory lesions (ILs) only.
|
|---|---|---|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.58%
1/172 • AE and SAE were collected up to Week 12.
For AE and SAE, ITT population was analyzed.
|
0.00%
0/177 • AE and SAE were collected up to Week 12.
For AE and SAE, ITT population was analyzed.
|
Other adverse events
| Measure |
Duac
n=172 participants at risk
Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 gram (g) which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
|
ADA 0.1% +CLDM 1%
n=177 participants at risk
Participants were instructed to use combination therapy of Adapalene (ADA) 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and clindamycin (CLDM) 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to inflammatory lesions (ILs) only.
|
|---|---|---|
|
General disorders
Application site dryness
|
9.3%
16/172 • Number of events 16 • AE and SAE were collected up to Week 12.
For AE and SAE, ITT population was analyzed.
|
24.9%
44/177 • Number of events 46 • AE and SAE were collected up to Week 12.
For AE and SAE, ITT population was analyzed.
|
|
Infections and infestations
Nasopharyngitis
|
7.0%
12/172 • Number of events 13 • AE and SAE were collected up to Week 12.
For AE and SAE, ITT population was analyzed.
|
8.5%
15/177 • Number of events 16 • AE and SAE were collected up to Week 12.
For AE and SAE, ITT population was analyzed.
|
|
General disorders
Application site pain
|
1.7%
3/172 • Number of events 3 • AE and SAE were collected up to Week 12.
For AE and SAE, ITT population was analyzed.
|
11.3%
20/177 • Number of events 21 • AE and SAE were collected up to Week 12.
For AE and SAE, ITT population was analyzed.
|
|
General disorders
Application site erythema
|
2.3%
4/172 • Number of events 4 • AE and SAE were collected up to Week 12.
For AE and SAE, ITT population was analyzed.
|
6.2%
11/177 • Number of events 12 • AE and SAE were collected up to Week 12.
For AE and SAE, ITT population was analyzed.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.2%
2/172 • Number of events 2 • AE and SAE were collected up to Week 12.
For AE and SAE, ITT population was analyzed.
|
5.6%
10/177 • Number of events 11 • AE and SAE were collected up to Week 12.
For AE and SAE, ITT population was analyzed.
|
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