Trial Outcomes & Findings for Comparison of the Efficacy and Safety of Clindamycin + Benzoyl Peroxide Formulation With Azelaic Acid Formulation in the Treatment of Acne Vulgaris (NCT NCT02058628)
NCT ID: NCT02058628
Last Updated: 2017-08-25
Results Overview
A count of IL (papules and pustules, including nasal lesions) was performed at baseline and up to Week 12. Lesion counts were confined to the face. Baseline was defined at Visit 1 (Day 1). Change from Baseline in the number of IL was defined as Week 4 values minus the Baseline values. Raw data has been presented for outcome measure results; however, p value is derived from the Wilcoxon test mean scores.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
222 participants
Primary outcome timeframe
Baseline (Day 1) and Week 4
Results posted on
2017-08-25
Participant Flow
This study was conducted from 21 February 2014 to 08 September 2014 across 11 centers in Germany. A total of 222 participants were enrolled.
Out of 222 enrolled participants, one was assessed as screening failure and thus, 221 participants were randomized with 111 allocated to Duac and 110 to Skinoren. Four randomized participants were not treated with any study drug and therefore the intent-to-treat population consisted of 217 participants.
Participant milestones
| Measure |
DUAC®
Participants received DUAC® (1.2 percent clindamycin + 3 percent of benzoyl peroxide \[BPO\]) once daily in the evening for 12 weeks as per the randomization schedule.
|
SKINOREN®
Participants received SKINOREN® (20 percent azelaic acid) twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization schedule.
|
|---|---|---|
|
Overall Study
STARTED
|
111
|
110
|
|
Overall Study
COMPLETED
|
104
|
102
|
|
Overall Study
NOT COMPLETED
|
7
|
8
|
Reasons for withdrawal
| Measure |
DUAC®
Participants received DUAC® (1.2 percent clindamycin + 3 percent of benzoyl peroxide \[BPO\]) once daily in the evening for 12 weeks as per the randomization schedule.
|
SKINOREN®
Participants received SKINOREN® (20 percent azelaic acid) twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization schedule.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
4
|
|
Overall Study
Not in time schedule
|
0
|
1
|
|
Overall Study
The visit date was not in timeline
|
0
|
1
|
|
Overall Study
A lot of time for study for participant
|
1
|
0
|
|
Overall Study
Non compliance
|
1
|
0
|
Baseline Characteristics
Comparison of the Efficacy and Safety of Clindamycin + Benzoyl Peroxide Formulation With Azelaic Acid Formulation in the Treatment of Acne Vulgaris
Baseline characteristics by cohort
| Measure |
DUAC®
n=108 Participants
Participants received DUAC® (1.2 percent clindamycin and 3 percent of BPO) once daily in the evening for 12 weeks as per the randomization schedule.
|
SKINOREN®
n=109 Participants
Participants received SKINOREN® (20 percent azelaic acid) twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization
|
Total
n=217 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
20.1 Years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
20.0 Years
STANDARD_DEVIATION 6.9 • n=7 Participants
|
20.1 Years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
94 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
196 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and Week 4Population: Modified intent-to-treat (MITT) population consisted of all participants in the ITT analysis set who had a baseline measurement of the number of IL and who had at least one post-baseline measurement of the number of IL.
A count of IL (papules and pustules, including nasal lesions) was performed at baseline and up to Week 12. Lesion counts were confined to the face. Baseline was defined at Visit 1 (Day 1). Change from Baseline in the number of IL was defined as Week 4 values minus the Baseline values. Raw data has been presented for outcome measure results; however, p value is derived from the Wilcoxon test mean scores.
Outcome measures
| Measure |
SKINOREN®
n=108 Participants
Participants received SKINOREN® (20 percent azelaic acid) twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization
|
DUAC®
n=107 Participants
Participants received DUAC® (1.2 percent clindamycin and 3 percent of BPO) once daily in the evening for 12 weeks as per the randomization schedule.
|
|---|---|---|
|
Percentage Change From Baseline (Day 1) of Inflammatory Lesion (IL) Count at Week 4 - Superiority Analysis
|
-38.1 Percent change
Standard Deviation 30.9
|
-51.9 Percent change
Standard Deviation 27.6
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Week 2, 4, 8, 12Population: MITT population. Only those participants available at the indicated time points were analyzed.
A count of IL (papules and pustules, including nasal lesions), NIL (open and closed comedones) and total lesions was performed at baseline and up to Week 12. Lesion counts were confined to the face. Baseline was defined at Visit 1 (Day 1). Change from Baseline in the number of IL was defined as week 12 values minus the Baseline values.
Outcome measures
| Measure |
SKINOREN®
n=108 Participants
Participants received SKINOREN® (20 percent azelaic acid) twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization
|
DUAC®
n=107 Participants
Participants received DUAC® (1.2 percent clindamycin and 3 percent of BPO) once daily in the evening for 12 weeks as per the randomization schedule.
|
|---|---|---|
|
Absolute Change From Baseline in IL, Non-inflammatory Lesions (NIL) and Calculated Total Lesions to Weeks 2, 4, 8 and 12
IL, WEEK 2
|
-6.3 Lesions
Standard Deviation 7.8
|
-10.3 Lesions
Standard Deviation 8.3
|
|
Absolute Change From Baseline in IL, Non-inflammatory Lesions (NIL) and Calculated Total Lesions to Weeks 2, 4, 8 and 12
IL, WEEK 4
|
-9.7 Lesions
Standard Deviation 8.6
|
-14.2 Lesions
Standard Deviation 9.1
|
|
Absolute Change From Baseline in IL, Non-inflammatory Lesions (NIL) and Calculated Total Lesions to Weeks 2, 4, 8 and 12
IL, WEEK 8
|
-12.7 Lesions
Standard Deviation 8.6
|
-17.7 Lesions
Standard Deviation 9.7
|
|
Absolute Change From Baseline in IL, Non-inflammatory Lesions (NIL) and Calculated Total Lesions to Weeks 2, 4, 8 and 12
IL, WEEK 12
|
-14.2 Lesions
Standard Deviation 8.9
|
-19.6 Lesions
Standard Deviation 10.1
|
|
Absolute Change From Baseline in IL, Non-inflammatory Lesions (NIL) and Calculated Total Lesions to Weeks 2, 4, 8 and 12
NIL, WEEK 2
|
-8.5 Lesions
Standard Deviation 13.3
|
-13.7 Lesions
Standard Deviation 19.0
|
|
Absolute Change From Baseline in IL, Non-inflammatory Lesions (NIL) and Calculated Total Lesions to Weeks 2, 4, 8 and 12
NIL, WEEK 4
|
-16.0 Lesions
Standard Deviation 19.1
|
-21.2 Lesions
Standard Deviation 21.5
|
|
Absolute Change From Baseline in IL, Non-inflammatory Lesions (NIL) and Calculated Total Lesions to Weeks 2, 4, 8 and 12
NIL, WEEK 8
|
-20.9 Lesions
Standard Deviation 23.6
|
-26.8 Lesions
Standard Deviation 27.1
|
|
Absolute Change From Baseline in IL, Non-inflammatory Lesions (NIL) and Calculated Total Lesions to Weeks 2, 4, 8 and 12
NIL, WEEK 12
|
-23.3 Lesions
Standard Deviation 24.9
|
-32.0 Lesions
Standard Deviation 27.2
|
|
Absolute Change From Baseline in IL, Non-inflammatory Lesions (NIL) and Calculated Total Lesions to Weeks 2, 4, 8 and 12
Total lesion, Week 2
|
-14.8 Lesions
Standard Deviation 16.7
|
-23.9 Lesions
Standard Deviation 22.3
|
|
Absolute Change From Baseline in IL, Non-inflammatory Lesions (NIL) and Calculated Total Lesions to Weeks 2, 4, 8 and 12
Total lesion, Week 4
|
-25.7 Lesions
Standard Deviation 22.3
|
-35.4 Lesions
Standard Deviation 25.0
|
|
Absolute Change From Baseline in IL, Non-inflammatory Lesions (NIL) and Calculated Total Lesions to Weeks 2, 4, 8 and 12
Total lesion, Week 8
|
-33.6 Lesions
Standard Deviation 27.5
|
-44.4 Lesions
Standard Deviation 31.3
|
|
Absolute Change From Baseline in IL, Non-inflammatory Lesions (NIL) and Calculated Total Lesions to Weeks 2, 4, 8 and 12
Total lesion, Week 12
|
-37.5 Lesions
Standard Deviation 29.0
|
-51.6 Lesions
Standard Deviation 30.9
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Week 2, 4, 8, 12Population: MITT population. Only those participants available at the indicated time points were analyzed.
A count of IL (papules and pustules, including nasal lesions),NIL (open and closed comedones) and total lesions was performed at baseline and up to Week 12. Lesion counts were confined to the face. Baseline was defined at Visit 1 (Day 1). Change from Baseline in the number of IL was defined as week 12 values minus the Baseline values.
Outcome measures
| Measure |
SKINOREN®
n=108 Participants
Participants received SKINOREN® (20 percent azelaic acid) twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization
|
DUAC®
n=107 Participants
Participants received DUAC® (1.2 percent clindamycin and 3 percent of BPO) once daily in the evening for 12 weeks as per the randomization schedule.
|
|---|---|---|
|
Percentage Change From Baseline in IL, NIL and Calculated Total Lesions at Weeks 2, 4, 8 and 12
NIL, Week 8
|
-35.5 Percent change
Standard Deviation 31.2
|
-48.5 Percent change
Standard Deviation 39.8
|
|
Percentage Change From Baseline in IL, NIL and Calculated Total Lesions at Weeks 2, 4, 8 and 12
NIL, Week 12
|
-42.1 Percent change
Standard Deviation 37.5
|
-60.6 Percent change
Standard Deviation 35.3
|
|
Percentage Change From Baseline in IL, NIL and Calculated Total Lesions at Weeks 2, 4, 8 and 12
Total lesions, Week 2
|
-18.4 Percent change
Standard Deviation 20.3
|
-28.7 Percent change
Standard Deviation 22.3
|
|
Percentage Change From Baseline in IL, NIL and Calculated Total Lesions at Weeks 2, 4, 8 and 12
IL, Week 2
|
-24.2 Percent change
Standard Deviation 30.3
|
-37.3 Percent change
Standard Deviation 27.7
|
|
Percentage Change From Baseline in IL, NIL and Calculated Total Lesions at Weeks 2, 4, 8 and 12
IL, Week 4
|
-38.1 Percent change
Standard Deviation 31.1
|
-52.2 Percent change
Standard Deviation 27.7
|
|
Percentage Change From Baseline in IL, NIL and Calculated Total Lesions at Weeks 2, 4, 8 and 12
IL, Week 8
|
-49.1 Percent change
Standard Deviation 30.9
|
-65.0 Percent change
Standard Deviation 26.3
|
|
Percentage Change From Baseline in IL, NIL and Calculated Total Lesions at Weeks 2, 4, 8 and 12
IL, Week 12
|
-55.0 Percent change
Standard Deviation 29.8
|
-72.3 Percent change
Standard Deviation 25.0
|
|
Percentage Change From Baseline in IL, NIL and Calculated Total Lesions at Weeks 2, 4, 8 and 12
NIL, Week 2
|
-14.9 Percent change
Standard Deviation 23.4
|
-23.5 Percent change
Standard Deviation 25.3
|
|
Percentage Change From Baseline in IL, NIL and Calculated Total Lesions at Weeks 2, 4, 8 and 12
NIL, Week 4
|
-27.0 Percent change
Standard Deviation 28.2
|
-38.1 Percent change
Standard Deviation 27.8
|
|
Percentage Change From Baseline in IL, NIL and Calculated Total Lesions at Weeks 2, 4, 8 and 12
Total lesions, Week 4
|
-30.8 Percent change
Standard Deviation 23.0
|
-43.8 Percent change
Standard Deviation 23.3
|
|
Percentage Change From Baseline in IL, NIL and Calculated Total Lesions at Weeks 2, 4, 8 and 12
Total lesions, Week 8
|
-40.1 Percent change
Standard Deviation 27.4
|
-55.2 Percent change
Standard Deviation 30.5
|
|
Percentage Change From Baseline in IL, NIL and Calculated Total Lesions at Weeks 2, 4, 8 and 12
Total lesions, Week 12
|
-46.1 Percent change
Standard Deviation 31.8
|
-64.6 Percent change
Standard Deviation 26.9
|
SECONDARY outcome
Timeframe: Week 12Population: MITT population. Only those participants available at the indicated time points were analyzed.
The average time to 50 percent reduction of the calculated total lesion count was analyzed by determination of the number of days between Baseline and the first visit with a 50 percent reduction of the count.
Outcome measures
| Measure |
SKINOREN®
n=60 Participants
Participants received SKINOREN® (20 percent azelaic acid) twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization
|
DUAC®
n=91 Participants
Participants received DUAC® (1.2 percent clindamycin and 3 percent of BPO) once daily in the evening for 12 weeks as per the randomization schedule.
|
|---|---|---|
|
Speed of Onset : Time to 50 Percent Reduction in Total Lesion Count
|
55.0 Days
Interval 12.0 to 97.0
|
52.0 Days
Interval 11.0 to 104.0
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Weeks 2, 4, 8, 12Population: MITT population.
ISGA was conducted at all study visits. The area considered for the ISGA was confined to the face. A 0-5 point rating scale was used: 0 means Clear- Clear skin with no IL or NIL, 1 means Almost Clear- Rare NIL with no more than one small IL, 2 means Mild- Some NIL with no more than a few IL (papules/pustules only, no nodular lesions), 3 means Moderate- Up to many NIL and may have some IL, but no more than one small nodular lesion, 4 means Severe- Up to many NIL and IL, but no more than a few nodular lesions and 5 means Very Severe- Many NIL and IL and more than a few nodular lesions, may have cystic lesions.
Outcome measures
| Measure |
SKINOREN®
n=108 Participants
Participants received SKINOREN® (20 percent azelaic acid) twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization
|
DUAC®
n=107 Participants
Participants received DUAC® (1.2 percent clindamycin and 3 percent of BPO) once daily in the evening for 12 weeks as per the randomization schedule.
|
|---|---|---|
|
Number of Participants With Change From Baseline in Investigator's Static Global Assessment (ISGA) to Weeks 2,4,8 and 12
Mild (Baseline) to Missing (Week 12)
|
2 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Investigator's Static Global Assessment (ISGA) to Weeks 2,4,8 and 12
Moderate (Baseline) to Clear (Week 12)
|
0 Participants
|
2 Participants
|
|
Number of Participants With Change From Baseline in Investigator's Static Global Assessment (ISGA) to Weeks 2,4,8 and 12
Moderate (Baseline) to Almost Clear (Week 12)
|
9 Participants
|
19 Participants
|
|
Number of Participants With Change From Baseline in Investigator's Static Global Assessment (ISGA) to Weeks 2,4,8 and 12
Moderate (Baseline) to Mild (Week 12)
|
26 Participants
|
33 Participants
|
|
Number of Participants With Change From Baseline in Investigator's Static Global Assessment (ISGA) to Weeks 2,4,8 and 12
Moderate (Baseline) to Severe (Week 12)
|
2 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Investigator's Static Global Assessment (ISGA) to Weeks 2,4,8 and 12
Moderate (Baseline) to Missing (Week 12)
|
2 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Investigator's Static Global Assessment (ISGA) to Weeks 2,4,8 and 12
Mild (Baseline) to Almost Clear (Week 2)
|
1 Participants
|
4 Participants
|
|
Number of Participants With Change From Baseline in Investigator's Static Global Assessment (ISGA) to Weeks 2,4,8 and 12
Mild (Baseline) to Moderate (Week 2)
|
8 Participants
|
3 Participants
|
|
Number of Participants With Change From Baseline in Investigator's Static Global Assessment (ISGA) to Weeks 2,4,8 and 12
Moderate (Baseline) to Almost Clear (Week 2)
|
1 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Investigator's Static Global Assessment (ISGA) to Weeks 2,4,8 and 12
Moderate (Baseline) to Mild (Week 2)
|
14 Participants
|
26 Participants
|
|
Number of Participants With Change From Baseline in Investigator's Static Global Assessment (ISGA) to Weeks 2,4,8 and 12
Moderate (Baseline) to Missing (Week 2)
|
0 Participants
|
2 Participants
|
|
Number of Participants With Change From Baseline in Investigator's Static Global Assessment (ISGA) to Weeks 2,4,8 and 12
Mild (Baseline) to Almost Clear (Week 4)
|
8 Participants
|
8 Participants
|
|
Number of Participants With Change From Baseline in Investigator's Static Global Assessment (ISGA) to Weeks 2,4,8 and 12
Mild (Baseline) to Moderate (Week 4)
|
4 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Investigator's Static Global Assessment (ISGA) to Weeks 2,4,8 and 12
Mild (Baseline) to Missing (Week 4)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Investigator's Static Global Assessment (ISGA) to Weeks 2,4,8 and 12
Moderate (Baseline) to Almost Clear (Week 4)
|
3 Participants
|
11 Participants
|
|
Number of Participants With Change From Baseline in Investigator's Static Global Assessment (ISGA) to Weeks 2,4,8 and 12
Moderate (Baseline) to Mild (Week 4)
|
24 Participants
|
29 Participants
|
|
Number of Participants With Change From Baseline in Investigator's Static Global Assessment (ISGA) to Weeks 2,4,8 and 12
Moderate (Baseline) to Severe (Week 4)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Investigator's Static Global Assessment (ISGA) to Weeks 2,4,8 and 12
Moderate (Baseline) to Missing (Week 4)
|
0 Participants
|
2 Participants
|
|
Number of Participants With Change From Baseline in Investigator's Static Global Assessment (ISGA) to Weeks 2,4,8 and 12
Mild (Baseline) to Clear (Week 8)
|
0 Participants
|
2 Participants
|
|
Number of Participants With Change From Baseline in Investigator's Static Global Assessment (ISGA) to Weeks 2,4,8 and 12
Mild (Baseline) to Almost Clear (Week 8)
|
10 Participants
|
10 Participants
|
|
Number of Participants With Change From Baseline in Investigator's Static Global Assessment (ISGA) to Weeks 2,4,8 and 12
Mild (Baseline) to Moderate (Week 8)
|
8 Participants
|
3 Participants
|
|
Number of Participants With Change From Baseline in Investigator's Static Global Assessment (ISGA) to Weeks 2,4,8 and 12
Mild (Baseline) to Missing (Week 8)
|
4 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Investigator's Static Global Assessment (ISGA) to Weeks 2,4,8 and 12
Moderate (Baseline) to Clear (Week 8)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Investigator's Static Global Assessment (ISGA) to Weeks 2,4,8 and 12
Moderate (Baseline) to Almost Clear (Week 8)
|
5 Participants
|
15 Participants
|
|
Number of Participants With Change From Baseline in Investigator's Static Global Assessment (ISGA) to Weeks 2,4,8 and 12
Moderate (Baseline) To Mild (Week 8)
|
27 Participants
|
32 Participants
|
|
Number of Participants With Change From Baseline in Investigator's Static Global Assessment (ISGA) to Weeks 2,4,8 and 12
Moderate (Baseline) to Missing (Week 8)
|
2 Participants
|
3 Participants
|
|
Number of Participants With Change From Baseline in Investigator's Static Global Assessment (ISGA) to Weeks 2,4,8 and 12
Mild (Baseline) to Clear (Week 12)
|
1 Participants
|
3 Participants
|
|
Number of Participants With Change From Baseline in Investigator's Static Global Assessment (ISGA) to Weeks 2,4,8 and 12
Mild (Baseline) to Almost Clear (Week 12)
|
9 Participants
|
12 Participants
|
|
Number of Participants With Change From Baseline in Investigator's Static Global Assessment (ISGA) to Weeks 2,4,8 and 12
Mild (Baseline) to Moderate (Week 12)
|
8 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12Population: MITT population.
Tolerability was assessed by investigator on a 0-3 point rating scale for erythema (0- None, 1- Slight, 2- Some and 3- Very red), dryness (0- None, 1- Slight, 2- Some and 3- Very dry) and peeling (0- None, 1- Slight, 2- Moderate and 3- Strong). A shift table was provided to deduce how the results are varying from the baseline visit to post-baseline visits. Change from Baseline is the value at indicated time point minus the Baseline value.
Outcome measures
| Measure |
SKINOREN®
n=108 Participants
Participants received SKINOREN® (20 percent azelaic acid) twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization
|
DUAC®
n=107 Participants
Participants received DUAC® (1.2 percent clindamycin and 3 percent of BPO) once daily in the evening for 12 weeks as per the randomization schedule.
|
|---|---|---|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Peeling None (Baseline) To Missing (Week 2)
|
0 Participants
|
2 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Peeling Slight (Baseline) To None (Week 2)
|
8 Participants
|
8 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Peeling Slight (Baseline) To Moderate (Week 2)
|
2 Participants
|
3 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Peeling Moderate (Baseline) To None (Week 2)
|
0 Participants
|
2 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Peeling Moderate (Baseline) To Slight (Week 2)
|
1 Participants
|
2 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Peeling Missing (Baseline) To None (Week 2)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Peeling None (Baseline) To Slight (Week 4)
|
11 Participants
|
9 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Peeling None (Baseline) To Missing (Week 4)
|
1 Participants
|
2 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Peeling Slight (Baseline) To None (Week 4)
|
13 Participants
|
15 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Peeling Slight (Baseline) To Moderate (Week 4)
|
1 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Peeling Moderate (Baseline) To None (Week 4)
|
1 Participants
|
2 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Peeling Moderate (Baseline) To Slight (Week 4)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Peeling Missing (Baseline) To None (Week 4)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Erythema None (Baseline) To Slight (Week 2)
|
18 Participants
|
11 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Erythema None (Baseline) To Some (Week 2)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Erythema None (Baseline) To Missing (Week 2)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Erythema Slight (Basline) To None (Week 2)
|
12 Participants
|
12 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Erythema Slight (Baseline) To Some (Week 2)
|
8 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Erythema Slight (Baseline) To Missing (Week 2)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Erythema Some (Baseline) To None (Week 2)
|
1 Participants
|
3 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Erythema Some (Baseline) To Slight (Week 2)
|
11 Participants
|
10 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Erythema Very Red (Baseline) To Slight (Week 2)
|
1 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Dryness None (Baseline) To Slight (Week 2)
|
9 Participants
|
14 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Dryness None (Baseline) To Some (Week 2)
|
3 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Dryness None (Baseline) To Missing (Week 2)
|
0 Participants
|
2 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Dryness Slight (Baseline) To None (Week 2)
|
7 Participants
|
11 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Dryness Slight (Baseline) To Some (Week 2)
|
6 Participants
|
3 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Dryness Some (Baseline) To None (Week 2)
|
2 Participants
|
4 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Dryness Some (Baseline) To Slight (Week 2)
|
2 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Dryness Missing (Baseline) To None (Week 2)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Dryness None (Baseline) To Slight (Week 4)
|
12 Participants
|
9 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Dryness None (Baseline) To Missing (Week 4)
|
1 Participants
|
2 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Dryness Slight (Baseline) To None (Week 4)
|
10 Participants
|
14 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Dryness Slight (Baseline) To Some (Week 4)
|
3 Participants
|
2 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Dryness Some (Baseline) To None (Week 4)
|
1 Participants
|
4 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Dryness Some (Baseline) To Slight (Week 4)
|
5 Participants
|
3 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Dryness Missing (Baseline) To None (Week 4)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Dryness None (Baseline) To Slight (Week 8)
|
11 Participants
|
8 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Dryness None (Baseline) To Missing (Week 8)
|
5 Participants
|
3 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Dryness Slight (Baseline) To None (Week 8)
|
12 Participants
|
19 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Dryness Slight (Baseline) To Some (Week 8)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Dryness Slight (Baseline) To Missing (Week 8)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Dryness Some (Baseline) To None (Week 8)
|
1 Participants
|
5 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Dryness Some (Baseline) To Slight (Week 8)
|
5 Participants
|
4 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Erythema None (Baseline) To Some (Week 8)
|
2 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Erythema None (Baseline) To Missing (Week 8)
|
2 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Erythema Slight (Baseline) To None (Week 8)
|
17 Participants
|
15 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Erythema Slight (Baseline) To Some (Week 8)
|
1 Participants
|
5 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Erythema Slight (Baseline) To Missing (Week 8)
|
3 Participants
|
2 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Erythema Some (Baseline) To None (Week 8)
|
1 Participants
|
8 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Erythema Some (Baseline) To Slight (Week 8)
|
12 Participants
|
9 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Erythema Some (Baseline) To Very Red (Week 8)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Erythema Some (Baseline) To Missing (Week 8)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Erythema Very Red (Baseline) To None (Week 8)
|
0 Participants
|
2 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Erythema Very Red (Baseline) To Slight (Week 8)
|
3 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Erythema Missing (Baseline) To Slight (Week 8)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Erythema None (Baseline) To Slight (Week 12)
|
18 Participants
|
6 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Erythema None (Baseline) To Missing (Week 12)
|
2 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Erythema Slight (Baseline) To None (Week 12)
|
22 Participants
|
21 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Erythema Slight (Baseline) To Some (Week 12)
|
2 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Erythema Slight (Baseline) To Very Red (Week 8)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Erythema Slight (Baseline) To Missing (Week 12)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Erythema Some (Baseline) To None (Week 12)
|
4 Participants
|
9 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Erythema Some (Baseline) To Slight (Week 12)
|
9 Participants
|
8 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Erythema Some (Baseline) To Missing (Week 12)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Erythema Very Red (Baseline) To None (Week 12)
|
2 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Erythema Very Red (Baseline) To Slight (Week 12)
|
1 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Erythema Missing (Baseline) To Slight (Week 12)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Peeling None (Baseline) To Slight (Week 2)
|
11 Participants
|
13 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Peeling None (Baseline) To Moderate (Week 2)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Peeling None (Baseline) To Slight (Week 8)
|
10 Participants
|
9 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Peeling None (Baseline) To Missing (Week 8)
|
5 Participants
|
3 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Peeling Slight (Baseline) To None (Week 8)
|
12 Participants
|
18 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Peeling Slight (Baseline) To Missing (Week 8)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Peeling Moderate (Baseline) To None (Week 8)
|
1 Participants
|
3 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Peeling Moderate (Baseline) To Slight (Week 8)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Peeling Missing (Baseline) To None (Week 8)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Peeling None (Baseline) To Slight (Week 12)
|
11 Participants
|
7 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Peeling None (Baseline) To Missing (Week 12)
|
3 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Peeling Slight (Baseline) To None (Week 12)
|
15 Participants
|
14 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Peeling Slight (Baseline) To Missing (Week 12)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Peeling Moderate (Baseline) To None (Week 12)
|
0 Participants
|
2 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Peeling Moderate (Baseline) To Slight (Week 12)
|
1 Participants
|
2 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Peeling Missing (Baseline) To None (Week 12)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Dryness Missing (Baseline) To None (Week 8)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Dryness None (Baseline) To Some (Week 12)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Dryness None (Baseline) To Slight (Week 12)
|
8 Participants
|
2 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Dryness None (Baseline) To Missing (Week 12)
|
3 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Dryness Slight (Baseline) To None (Week 12)
|
15 Participants
|
14 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Dryness Slight (Baseline) To Some (Week 12)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Dryness Slight (Baseline) To Missing (Week 12)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Dryness Some (Baseline) To None (Week 12)
|
3 Participants
|
6 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Dryness Some (Baseline) To Slight (Week 12)
|
3 Participants
|
3 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Dryness Missing (Baseline) To None (Week 12)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Erythema Very Red (Baseline) To Some (Week 2)
|
2 Participants
|
2 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Erythema Missing (Baseline) To None (Week 2)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Erythema None (Baseline) To Slight (Week 4)
|
13 Participants
|
9 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Erythema None (Baseline) To Some (Week 4)
|
3 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Erythema None (Baseline) To Missing (Week 4)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Erythema Slight (Baseline) To None (Week 4)
|
19 Participants
|
18 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Erythema Slight (Baseline) To Some (Week 4)
|
1 Participants
|
3 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Erythema Slight (Baseline) To Missing (Week 4)
|
1 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Erythema Some (Baseline) To None (Week 4)
|
3 Participants
|
5 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Erythema Some (Baseline) To Slight (Week 4)
|
9 Participants
|
11 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Erythema Some (Baseline) To Missing (Week 4)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Erythema Very Red (Baseline) To Slight (Week 4)
|
2 Participants
|
2 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Erythema Very Red (Baseline) To Some (Week 4)
|
1 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Erythema Missing (Baseline) To None (Week 4)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Erythema None (Baseline) To Slight (Week 8)
|
19 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8 and 12Population: MITT population.
An SGCA was conducted by the participant to assess the efficacy of treatment on Week 2, 4, 8 and 12 as Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse, Very Much Worse and missing.
Outcome measures
| Measure |
SKINOREN®
n=108 Participants
Participants received SKINOREN® (20 percent azelaic acid) twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization
|
DUAC®
n=107 Participants
Participants received DUAC® (1.2 percent clindamycin and 3 percent of BPO) once daily in the evening for 12 weeks as per the randomization schedule.
|
|---|---|---|
|
Number of Participants With Participant Global Change Assessment Score 12 Weeks
Very much improved (Week 2)
|
2 Participants
|
4 Participants
|
|
Number of Participants With Participant Global Change Assessment Score 12 Weeks
Much improved (Week 2)
|
30 Participants
|
51 Participants
|
|
Number of Participants With Participant Global Change Assessment Score 12 Weeks
Minimally improved (Week 2)
|
56 Participants
|
44 Participants
|
|
Number of Participants With Participant Global Change Assessment Score 12 Weeks
No change (Week 2)
|
14 Participants
|
6 Participants
|
|
Number of Participants With Participant Global Change Assessment Score 12 Weeks
Minimally worse (Week 2)
|
6 Participants
|
0 Participants
|
|
Number of Participants With Participant Global Change Assessment Score 12 Weeks
Missing (Week 2)
|
0 Participants
|
2 Participants
|
|
Number of Participants With Participant Global Change Assessment Score 12 Weeks
Very much improved (Week 4)
|
0 Participants
|
5 Participants
|
|
Number of Participants With Participant Global Change Assessment Score 12 Weeks
Much improved (Week 4)
|
39 Participants
|
48 Participants
|
|
Number of Participants With Participant Global Change Assessment Score 12 Weeks
Minimally improved (Week 4)
|
49 Participants
|
44 Participants
|
|
Number of Participants With Participant Global Change Assessment Score 12 Weeks
No change (Week 4)
|
12 Participants
|
2 Participants
|
|
Number of Participants With Participant Global Change Assessment Score 12 Weeks
Minimally worse (Week 4)
|
7 Participants
|
6 Participants
|
|
Number of Participants With Participant Global Change Assessment Score 12 Weeks
Missing (Week 4)
|
1 Participants
|
2 Participants
|
|
Number of Participants With Participant Global Change Assessment Score 12 Weeks
Very much improved (Week 8)
|
1 Participants
|
9 Participants
|
|
Number of Participants With Participant Global Change Assessment Score 12 Weeks
Much improved (Week 8)
|
44 Participants
|
54 Participants
|
|
Number of Participants With Participant Global Change Assessment Score 12 Weeks
Minimally improved (Week 8)
|
32 Participants
|
30 Participants
|
|
Number of Participants With Participant Global Change Assessment Score 12 Weeks
No change (Week 8)
|
15 Participants
|
7 Participants
|
|
Number of Participants With Participant Global Change Assessment Score 12 Weeks
Minimally worse (Week 8)
|
8 Participants
|
3 Participants
|
|
Number of Participants With Participant Global Change Assessment Score 12 Weeks
Much worse (Week 8)
|
1 Participants
|
1 Participants
|
|
Number of Participants With Participant Global Change Assessment Score 12 Weeks
Very much worse (Week 8)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Participant Global Change Assessment Score 12 Weeks
Missing (Week 8)
|
6 Participants
|
3 Participants
|
|
Number of Participants With Participant Global Change Assessment Score 12 Weeks
Very much improved (Week 12)
|
8 Participants
|
14 Participants
|
|
Number of Participants With Participant Global Change Assessment Score 12 Weeks
Much improved (Week 12)
|
38 Participants
|
48 Participants
|
|
Number of Participants With Participant Global Change Assessment Score 12 Weeks
Minimally improved (Week 12)
|
33 Participants
|
29 Participants
|
|
Number of Participants With Participant Global Change Assessment Score 12 Weeks
No change (Week 12)
|
17 Participants
|
10 Participants
|
|
Number of Participants With Participant Global Change Assessment Score 12 Weeks
Minimally worse (Week 12)
|
5 Participants
|
4 Participants
|
|
Number of Participants With Participant Global Change Assessment Score 12 Weeks
Much worse (Week 12)
|
2 Participants
|
0 Participants
|
|
Number of Participants With Participant Global Change Assessment Score 12 Weeks
Very much worse (Week 12)
|
1 Participants
|
2 Participants
|
|
Number of Participants With Participant Global Change Assessment Score 12 Weeks
Missing (Week 12)
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Weeks 2, 4, 8 and 12Population: MITT population.
Tolerability was assessed by the participants based on a 0-3 point rating scale for stinging/burning (S/B) and pruritus of the face (0- None, 1- Slight, 2- Moderate and 3- Strong). A shift table was provided to deduce how the results are varying from the Baseline visit to post-baseline visits.
Outcome measures
| Measure |
SKINOREN®
n=108 Participants
Participants received SKINOREN® (20 percent azelaic acid) twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization
|
DUAC®
n=107 Participants
Participants received DUAC® (1.2 percent clindamycin and 3 percent of BPO) once daily in the evening for 12 weeks as per the randomization schedule.
|
|---|---|---|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
S/B None (Baseline) To Moderate (Week 8)
|
4 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
S/B None (Baseline) To Slight (Week 2)
|
23 Participants
|
14 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
S/B None (Baseline) To Moderate (Week 2)
|
8 Participants
|
4 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
S/B None (Baseline) To Strong (Week 2)
|
4 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
S/B None (Baseline) To Missing (Week 2)
|
0 Participants
|
2 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
S/B Slight (Baseline) To None (Week 2)
|
10 Participants
|
14 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
S/B Slight (Baseline) To Moderate (Week 2)
|
2 Participants
|
3 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
S/B Slight (Baseline) To Strong (Week 2)
|
2 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
S/B Moderate (Baseline) To None (Week 2)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
S/B Moderate (Baseline) To Slight (Week 2)
|
3 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
S/B Strong (Baseline) To None (Week 2)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
S/B Missing (Baseline) To None (Week 2)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
S/B None (Baseline) To Missing (Week 8)
|
5 Participants
|
3 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
S/B None (Baseline) To Slight (Week 4)
|
29 Participants
|
11 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
S/B None (Baseline) To Moderate (Week 4)
|
6 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
S/B None (Baseline) To Missing (Week 4)
|
1 Participants
|
2 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
S/B Slight (Baseline) To None (Week 4)
|
9 Participants
|
12 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
S/B Slight (Baseline) To Moderate (Week 4)
|
1 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
S/B Slight (Baseline) To Strong (Week 4)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
S/B Moderate (Baseline) To None (Week 4)
|
2 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
S/B Moderate (Baseline) To Slight (Week 4)
|
3 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
S/B Moderate (Baseline) To Strong (Week 4)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
S/B None (Baseline) To Strong (Week 8)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
S/B Slight (Baseline) To None (Week 8)
|
10 Participants
|
18 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
S/B Strong (Baseline) To None (Week 4)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
S/B Slight (Baseline) To Moderate (Week 8)
|
1 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
S/B Missing (Baseline) To Slight (Week 4)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
S/B None (Baseline) To Slight (Week 8)
|
21 Participants
|
5 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
S/B Slight (Baseline) To Strong (Week 8)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
S/B Moderate (Baseline) To Missing (Week 8)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
S/B Moderate (Baseline) To None (Week 8)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
S/B Strong (Baseline) To None (Week 8)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
S/B Missing (Baseline) To None (Week 8)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
S/B Moderate (Baseline) To Slight (Week 8)
|
2 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
S/B None (Baseline) To Slight (Week 12)
|
19 Participants
|
6 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
S/B None (Baseline) To Moderate (Week 12)
|
5 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
S/B None (Baseline) To Strong (Week 12)
|
2 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
S/B None (Baseline) To Missing (Week 12)
|
4 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
S/B Slight (Baseline) To None (Week 12)
|
9 Participants
|
18 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
Pruritus None (Baseline) To Missing (Week 2)
|
0 Participants
|
2 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
S/B Slight (Baseline) To Moderate (Week 12)
|
3 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
S/B Slight (Baseline) To Strong (Week 12)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
S/B Moderate (Baseline) To None (Week 12)
|
2 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
S/B Moderate (Baseline) To Slight (Week 12)
|
3 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
Pruritus Slight (Baseline) To None (Week 2)
|
10 Participants
|
13 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
S/B Strong (Baseline) To Slight (Week 12)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
S/B Missing (Baseline) To None (Week 12)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
Pruritus None (Baseline) To Slight (Week 2)
|
27 Participants
|
14 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
Pruritus None (Baseline) To Moderate (Week 2)
|
7 Participants
|
4 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
Pruritus None (Baseline) To Strong (Week 2)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
Pruritus Slight (Baseline) To Moderate (Week 2)
|
9 Participants
|
5 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
Pruritus Slight (Baseline) To Strong (Week 2)
|
4 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
Pruritus Moderate (Baseline) To None (Week 2)
|
4 Participants
|
2 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
Pruritus Moderate (Baseline) To Slight (Week 2)
|
1 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
Pruritus Moderate (Baseline) To None (Week 4)
|
2 Participants
|
2 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
Pruritus Missing (Baseline) To None (Week 2)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
Pruritus Moderate (Baseline) To Slight (Week 4)
|
2 Participants
|
2 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
Pruritus Missing (Baseline) To None (Week 4)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
Pruritus None (Baseline) To Slight (Week 8)
|
26 Participants
|
13 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
Pruritus None (Baseline) To Missing (Week 8)
|
3 Participants
|
3 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
Pruritus None (Baseline) To Strong (Week 8)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
Pruritus Slight (Baseline) To None (Week 8)
|
11 Participants
|
21 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
Pruritus Slight (Baseline) To Moderate (Week 8)
|
4 Participants
|
4 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
Pruritus None (Baseline) To Slight (Week 4)
|
30 Participants
|
14 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
Pruritus None (Baseline) To Moderate (Week 4)
|
5 Participants
|
2 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
Pruritus None (Baseline) To Missing (Week 4)
|
1 Participants
|
2 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
Pruritus Slight (Baseline) To Strong (Week 8)
|
2 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
Pruritus Slight (Baseline) To Missing (Week 8)
|
3 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
Pruritus Moderate (Baseline) To None (Week 8)
|
2 Participants
|
3 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
Pruritus Moderate (Baseline) To Slight (Week 8)
|
3 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
Pruritus Strong (Baseline) To Moderate (Week 8)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
Pruritus Missing (Baseline) To None (Week 8)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
Pruritus None (Baseline) To Slight (Week 12)
|
22 Participants
|
11 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
Pruritus Slight (Baseline) To None (Week 4)
|
12 Participants
|
17 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
Pruritus Slight (Baseline) To Moderate (Week 4)
|
6 Participants
|
2 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
Pruritus Slight (Baseline) To Strong (Week 4)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
Pruritus None (Baseline) To Moderate (Week 12)
|
3 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
Pruritus None (Baseline) To Strong (Week 12)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
Pruritus None (Baseline) To Missing (Week 12)
|
4 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
Pruritus Slight (Baseline) To None (Week 12)
|
11 Participants
|
22 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
Pruritus Slight (Baseline) To Moderate (Week 12)
|
6 Participants
|
2 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
Pruritus Slight (Baseline) To Strong (Week 12)
|
2 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
Pruritus Moderate (Baseline) To None (Week 12)
|
1 Participants
|
3 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
Pruritus Moderate (Baseline) To Slight (Week 12)
|
4 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
Pruritus Strong (Baseline) To Slight (Week 12)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
Pruritus Missing (Baseline) To None (Week 12)
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: MITT population.
The product acceptability and preference questionnaire (PAP-Q ) served as a patient satisfaction score and was performed only once at the final study visit (ie, after 12 weeks (V5) or earlier in case of premature termination). Severity of each facial acne sign and symptom (scaling, redness, dryness, burning, itching) was based on a 0-5 point rating scale (0- None, 1- Very minimal, 2- Mild, 3- Moderate, 4- Severe, 5- Very severe).
Outcome measures
| Measure |
SKINOREN®
n=108 Participants
Participants received SKINOREN® (20 percent azelaic acid) twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization
|
DUAC®
n=107 Participants
Participants received DUAC® (1.2 percent clindamycin and 3 percent of BPO) once daily in the evening for 12 weeks as per the randomization schedule.
|
|---|---|---|
|
Number of Participants With Participant Satisfaction Score at Week 12 (Simple Grading)
Redness, None
|
47 Participants
|
55 Participants
|
|
Number of Participants With Participant Satisfaction Score at Week 12 (Simple Grading)
Redness, Very minimal
|
20 Participants
|
32 Participants
|
|
Number of Participants With Participant Satisfaction Score at Week 12 (Simple Grading)
Redness, Mild
|
17 Participants
|
8 Participants
|
|
Number of Participants With Participant Satisfaction Score at Week 12 (Simple Grading)
Redness, Moderate
|
13 Participants
|
9 Participants
|
|
Number of Participants With Participant Satisfaction Score at Week 12 (Simple Grading)
Redness, Severe
|
5 Participants
|
2 Participants
|
|
Number of Participants With Participant Satisfaction Score at Week 12 (Simple Grading)
Redness, Very severe
|
2 Participants
|
1 Participants
|
|
Number of Participants With Participant Satisfaction Score at Week 12 (Simple Grading)
Redness, Not applicable
|
1 Participants
|
0 Participants
|
|
Number of Participants With Participant Satisfaction Score at Week 12 (Simple Grading)
Dryness, None
|
41 Participants
|
43 Participants
|
|
Number of Participants With Participant Satisfaction Score at Week 12 (Simple Grading)
Dryness, Very minimal
|
28 Participants
|
32 Participants
|
|
Number of Participants With Participant Satisfaction Score at Week 12 (Simple Grading)
Dryness, Mild
|
24 Participants
|
20 Participants
|
|
Number of Participants With Participant Satisfaction Score at Week 12 (Simple Grading)
Dryness, Moderate
|
7 Participants
|
9 Participants
|
|
Number of Participants With Participant Satisfaction Score at Week 12 (Simple Grading)
Dryness, Severe
|
2 Participants
|
2 Participants
|
|
Number of Participants With Participant Satisfaction Score at Week 12 (Simple Grading)
Dryness, Very severe
|
2 Participants
|
1 Participants
|
|
Number of Participants With Participant Satisfaction Score at Week 12 (Simple Grading)
Dryness, Not applicable
|
1 Participants
|
0 Participants
|
|
Number of Participants With Participant Satisfaction Score at Week 12 (Simple Grading)
Burning, None
|
50 Participants
|
90 Participants
|
|
Number of Participants With Participant Satisfaction Score at Week 12 (Simple Grading)
Burning, Very minimal
|
28 Participants
|
8 Participants
|
|
Number of Participants With Participant Satisfaction Score at Week 12 (Simple Grading)
Burning, Mild
|
12 Participants
|
5 Participants
|
|
Number of Participants With Participant Satisfaction Score at Week 12 (Simple Grading)
Burning, Moderate
|
9 Participants
|
3 Participants
|
|
Number of Participants With Participant Satisfaction Score at Week 12 (Simple Grading)
Burning, Severe
|
5 Participants
|
1 Participants
|
|
Number of Participants With Participant Satisfaction Score at Week 12 (Simple Grading)
Burning, Very severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Participant Satisfaction Score at Week 12 (Simple Grading)
Burning, Not applicable
|
1 Participants
|
0 Participants
|
|
Number of Participants With Participant Satisfaction Score at Week 12 (Simple Grading)
Itching, None
|
38 Participants
|
73 Participants
|
|
Number of Participants With Participant Satisfaction Score at Week 12 (Simple Grading)
Itching, Very minimal
|
30 Participants
|
17 Participants
|
|
Number of Participants With Participant Satisfaction Score at Week 12 (Simple Grading)
Itching, Mild
|
20 Participants
|
10 Participants
|
|
Number of Participants With Participant Satisfaction Score at Week 12 (Simple Grading)
Itching, Moderate
|
11 Participants
|
6 Participants
|
|
Number of Participants With Participant Satisfaction Score at Week 12 (Simple Grading)
Itching, Severe
|
3 Participants
|
1 Participants
|
|
Number of Participants With Participant Satisfaction Score at Week 12 (Simple Grading)
Itching, Very severe
|
2 Participants
|
0 Participants
|
|
Number of Participants With Participant Satisfaction Score at Week 12 (Simple Grading)
Itching, Not applicable
|
1 Participants
|
0 Participants
|
|
Number of Participants With Participant Satisfaction Score at Week 12 (Simple Grading)
Scaling, None
|
77 Participants
|
69 Participants
|
|
Number of Participants With Participant Satisfaction Score at Week 12 (Simple Grading)
Scaling, Very minimal
|
9 Participants
|
24 Participants
|
|
Number of Participants With Participant Satisfaction Score at Week 12 (Simple Grading)
Scaling, Mild
|
7 Participants
|
7 Participants
|
|
Number of Participants With Participant Satisfaction Score at Week 12 (Simple Grading)
Scaling, Moderate
|
7 Participants
|
2 Participants
|
|
Number of Participants With Participant Satisfaction Score at Week 12 (Simple Grading)
Scaling, Severe
|
4 Participants
|
4 Participants
|
|
Number of Participants With Participant Satisfaction Score at Week 12 (Simple Grading)
Scaling, Very severe
|
0 Participants
|
1 Participants
|
|
Number of Participants With Participant Satisfaction Score at Week 12 (Simple Grading)
Scaling, Not applicable
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: MITT population.
The general assessment of 'overall satisfaction' with study therapy was assessed at week 12 on a 0-4 point rating scale (0-Very satisfied, 1- Satisfied, 2- Neutral, 3- Unsatisfied and 4- Very unsatisfied).
Outcome measures
| Measure |
SKINOREN®
n=108 Participants
Participants received SKINOREN® (20 percent azelaic acid) twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization
|
DUAC®
n=107 Participants
Participants received DUAC® (1.2 percent clindamycin and 3 percent of BPO) once daily in the evening for 12 weeks as per the randomization schedule.
|
|---|---|---|
|
Number of Treatment Adherent Participants at Week 12
Very satisfied
|
26 Participants
|
41 Participants
|
|
Number of Treatment Adherent Participants at Week 12
Satisfied
|
43 Participants
|
61 Participants
|
|
Number of Treatment Adherent Participants at Week 12
Neutral
|
21 Participants
|
4 Participants
|
|
Number of Treatment Adherent Participants at Week 12
Unsatisfied
|
11 Participants
|
1 Participants
|
|
Number of Treatment Adherent Participants at Week 12
Very unsatisfied
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Weeks 2, 4, 8, 12Population: MITT population. Only those participants available at the indicated time points were analyzed.
This outcome measure was a measure of quality of life (QOL). The DLQI was used to assess the quality of life at each visit. Participants completed the questionnaire to evaluate how their acne has affected their life. The DLQI is a 10 item questionnaire, which addresses feelings, daily activities, leisure, work, school, personal relationships, and treatment. Each question was scored out of 0-3, as follows: 0- Not at all, 1- A little, 2- A lot, 3- very much, indicating 0 as the least and 3 as the best quality Index. The sub-scale scores of 10 questions were combined and a composite score was presented. The total score ranged from 0 to 30, 0 indicated the least and highest score indicated the best quality Index. The DLQI was for participants with 17 to 45 years of age. Baseline was defined at Visit 1 (Day 1). Change from Baseline is the value at indicated time point minus the Baseline value.
Outcome measures
| Measure |
SKINOREN®
n=61 Participants
Participants received SKINOREN® (20 percent azelaic acid) twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization
|
DUAC®
n=62 Participants
Participants received DUAC® (1.2 percent clindamycin and 3 percent of BPO) once daily in the evening for 12 weeks as per the randomization schedule.
|
|---|---|---|
|
Absolute Change From Baseline in Total Score as Per Dermatology Life Quality Index (DLQI) at Week 2,4,8 and 12
Week 12
|
-3.12 Scores on a scale
Standard Deviation 4.94
|
-4.46 Scores on a scale
Standard Deviation 3.80
|
|
Absolute Change From Baseline in Total Score as Per Dermatology Life Quality Index (DLQI) at Week 2,4,8 and 12
Week 2
|
-2.17 Scores on a scale
Standard Deviation 3.72
|
-2.28 Scores on a scale
Standard Deviation 2.81
|
|
Absolute Change From Baseline in Total Score as Per Dermatology Life Quality Index (DLQI) at Week 2,4,8 and 12
Week 4
|
-3.15 Scores on a scale
Standard Deviation 3.52
|
-3.39 Scores on a scale
Standard Deviation 3.33
|
|
Absolute Change From Baseline in Total Score as Per Dermatology Life Quality Index (DLQI) at Week 2,4,8 and 12
Week 8
|
-3.38 Scores on a scale
Standard Deviation 4.60
|
-4.04 Scores on a scale
Standard Deviation 3.70
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Weeks 2, 4, 8, 12Population: MITT population. Only those participants available at the indicated time points were analyzed.
This outcome measure was a measure of QOL. The CDLQI was used to assess the quality of life at each visit. Participants completed the questionnaire to evaluate how their acne has affected their life. The DLQI is a 10 item questionnaire, which addresses feelings, daily activities, leisure, work, school, personal relationships, and treatment. Each question was scored out of 0-3, as follows: 0- Not at all, 1- A little, 2- A lot, 3- very much, indicating 0 as the least and 3 as the best quality Index. The sub-scale scores of 10 questions were combined and a composite score was presented. The total score ranged from 0 to 30, 0 indicated the least and highest score indicated the best quality Index. The CDLQI was for participants with 12 to 16 years of age. Baseline was defined at Visit 1 (Day 1). Change from Baseline is the value at indicated time point minus the Baseline value.
Outcome measures
| Measure |
SKINOREN®
n=42 Participants
Participants received SKINOREN® (20 percent azelaic acid) twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization
|
DUAC®
n=38 Participants
Participants received DUAC® (1.2 percent clindamycin and 3 percent of BPO) once daily in the evening for 12 weeks as per the randomization schedule.
|
|---|---|---|
|
Absolute Change From Baseline in Total Score as Per Children's Dermatology Life Quality Index (CDLQI) at Week 2,4,8 and 12
Week 2
|
-1.31 Scores on a scale
Standard Deviation 2.29
|
-2.61 Scores on a scale
Standard Deviation 2.89
|
|
Absolute Change From Baseline in Total Score as Per Children's Dermatology Life Quality Index (CDLQI) at Week 2,4,8 and 12
Week 4
|
-1.55 Scores on a scale
Standard Deviation 2.01
|
-2.55 Scores on a scale
Standard Deviation 2.41
|
|
Absolute Change From Baseline in Total Score as Per Children's Dermatology Life Quality Index (CDLQI) at Week 2,4,8 and 12
Week 8
|
-1.67 Scores on a scale
Standard Deviation 2.34
|
-2.68 Scores on a scale
Standard Deviation 2.76
|
|
Absolute Change From Baseline in Total Score as Per Children's Dermatology Life Quality Index (CDLQI) at Week 2,4,8 and 12
Week 12
|
-1.55 Scores on a scale
Standard Deviation 2.56
|
-2.87 Scores on a scale
Standard Deviation 2.75
|
SECONDARY outcome
Timeframe: Up to Week 12Population: ITT population.
Adverse events are defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious adverse events are defined as any untoward medical occurrence that results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect and medically significant. TEAEs and TESAEs were reported up to 12 weeks.
Outcome measures
| Measure |
SKINOREN®
n=109 Participants
Participants received SKINOREN® (20 percent azelaic acid) twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization
|
DUAC®
n=108 Participants
Participants received DUAC® (1.2 percent clindamycin and 3 percent of BPO) once daily in the evening for 12 weeks as per the randomization schedule.
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs) Related to Study Medication
TEAE
|
76 Participants
|
60 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs) Related to Study Medication
TESAE
|
3 Participants
|
2 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs) Related to Study Medication
TEAEs related to the study drug
|
36 Participants
|
15 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs) Related to Study Medication
TESAEs related to the study drug
|
0 Participants
|
0 Participants
|
Adverse Events
DUAC®
Serious events: 2 serious events
Other events: 32 other events
Deaths: 0 deaths
SKINOREN®
Serious events: 3 serious events
Other events: 55 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DUAC®
n=108 participants at risk
Participants received DUAC® (1.2 percent clindamycin and 3 percent of benzoyl peroxide (BPO)) once daily in the evening for 12 weeks as per the randomization schedule
|
SKINOREN®
n=109 participants at risk
Participants received SKINOREN® (20 percent azelaic acid) twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization schedule
|
|---|---|---|
|
Infections and infestations
Brucellosis
|
0.93%
1/108 • Adverse events and serious adverse events were collected up to Week 12.
Intent-to-treat population consisted of all participants who were randomized and who used the test medication at least once.
|
0.00%
0/109 • Adverse events and serious adverse events were collected up to Week 12.
Intent-to-treat population consisted of all participants who were randomized and who used the test medication at least once.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/108 • Adverse events and serious adverse events were collected up to Week 12.
Intent-to-treat population consisted of all participants who were randomized and who used the test medication at least once.
|
0.92%
1/109 • Adverse events and serious adverse events were collected up to Week 12.
Intent-to-treat population consisted of all participants who were randomized and who used the test medication at least once.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/108 • Adverse events and serious adverse events were collected up to Week 12.
Intent-to-treat population consisted of all participants who were randomized and who used the test medication at least once.
|
0.92%
1/109 • Adverse events and serious adverse events were collected up to Week 12.
Intent-to-treat population consisted of all participants who were randomized and who used the test medication at least once.
|
|
Psychiatric disorders
Stress
|
0.93%
1/108 • Adverse events and serious adverse events were collected up to Week 12.
Intent-to-treat population consisted of all participants who were randomized and who used the test medication at least once.
|
0.00%
0/109 • Adverse events and serious adverse events were collected up to Week 12.
Intent-to-treat population consisted of all participants who were randomized and who used the test medication at least once.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/108 • Adverse events and serious adverse events were collected up to Week 12.
Intent-to-treat population consisted of all participants who were randomized and who used the test medication at least once.
|
0.92%
1/109 • Adverse events and serious adverse events were collected up to Week 12.
Intent-to-treat population consisted of all participants who were randomized and who used the test medication at least once.
|
|
Reproductive system and breast disorders
Vulval haematoma
|
0.93%
1/108 • Adverse events and serious adverse events were collected up to Week 12.
Intent-to-treat population consisted of all participants who were randomized and who used the test medication at least once.
|
0.00%
0/109 • Adverse events and serious adverse events were collected up to Week 12.
Intent-to-treat population consisted of all participants who were randomized and who used the test medication at least once.
|
Other adverse events
| Measure |
DUAC®
n=108 participants at risk
Participants received DUAC® (1.2 percent clindamycin and 3 percent of benzoyl peroxide (BPO)) once daily in the evening for 12 weeks as per the randomization schedule
|
SKINOREN®
n=109 participants at risk
Participants received SKINOREN® (20 percent azelaic acid) twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization schedule
|
|---|---|---|
|
General disorders
Application site pain
|
6.5%
7/108 • Adverse events and serious adverse events were collected up to Week 12.
Intent-to-treat population consisted of all participants who were randomized and who used the test medication at least once.
|
20.2%
22/109 • Adverse events and serious adverse events were collected up to Week 12.
Intent-to-treat population consisted of all participants who were randomized and who used the test medication at least once.
|
|
General disorders
Application site pruritus
|
7.4%
8/108 • Adverse events and serious adverse events were collected up to Week 12.
Intent-to-treat population consisted of all participants who were randomized and who used the test medication at least once.
|
22.9%
25/109 • Adverse events and serious adverse events were collected up to Week 12.
Intent-to-treat population consisted of all participants who were randomized and who used the test medication at least once.
|
|
Infections and infestations
Nasopharyngitis
|
9.3%
10/108 • Adverse events and serious adverse events were collected up to Week 12.
Intent-to-treat population consisted of all participants who were randomized and who used the test medication at least once.
|
18.3%
20/109 • Adverse events and serious adverse events were collected up to Week 12.
Intent-to-treat population consisted of all participants who were randomized and who used the test medication at least once.
|
|
Nervous system disorders
Headache
|
14.8%
16/108 • Adverse events and serious adverse events were collected up to Week 12.
Intent-to-treat population consisted of all participants who were randomized and who used the test medication at least once.
|
16.5%
18/109 • Adverse events and serious adverse events were collected up to Week 12.
Intent-to-treat population consisted of all participants who were randomized and who used the test medication at least once.
|
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