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Trial record 46 of 134 for:    acne AND peroxide

Comparison of the Efficacy and Safety of Clindamycin + Benzoyl Peroxide Formulation With Azelaic Acid Formulation in the Treatment of Acne Vulgaris

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ClinicalTrials.gov Identifier: NCT02058628
Recruitment Status : Completed
First Posted : February 10, 2014
Results First Posted : August 25, 2017
Last Update Posted : August 25, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: Clindamycin + BPO
Drug: Azelaic acid
Enrollment 222
Recruitment Details This study was conducted from 21 February 2014 to 08 September 2014 across 11 centers in Germany. A total of 222 participants were enrolled.
Pre-assignment Details 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.
Arm/Group Title DUAC® SKINOREN®
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 111 110
Completed 104 102
Not Completed 7 8
Reason Not Completed
Adverse Event             1             0
Withdrawal by Subject             2             2
Lost to Follow-up             2             4
Not in time schedule             0             1
The visit date was not in timeline             0             1
A lot of time for study for participant             1             0
Non compliance             1             0
Arm/Group Title DUAC® SKINOREN® Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 108 109 217
Hide Baseline Analysis Population Description
Out of 221 randomized participants, 4 participants did not receive study medication. Hence, the Intent-to-treat (ITT) population consisted of 217 participants
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 108 participants 109 participants 217 participants
20.1  (7.1) 20.0  (6.9) 20.1  (7.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 108 participants 109 participants 217 participants
Female
61
  56.5%
58
  53.2%
119
  54.8%
Male
47
  43.5%
51
  46.8%
98
  45.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 108 participants 109 participants 217 participants
Asian 5 0 5
Caucasian 94 102 196
African 1 1 2
Other 8 6 14
1.Primary Outcome
Title Percentage Change From Baseline (Day 1) of Inflammatory Lesion (IL) Count at Week 4 – Superiority Analysis
Hide Description 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.
Time Frame Baseline (Day 1) and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title DUAC® SKINOREN®
Hide Arm/Group Description:
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.
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
Overall Number of Participants Analyzed 107 108
Mean (Standard Deviation)
Unit of Measure: Percent change
-51.9  (27.6) -38.1  (30.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DUAC®, SKINOREN®
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments Data is represented as per CTR.
Method Wilcoxon (Mann-Whitney)
Comments DUAC versus SKINOREN with a nominal alpha level of 5%, without adjustment for multiple comparisons.
2.Secondary Outcome
Title Absolute Change From Baseline in IL, Non-inflammatory Lesions (NIL) and Calculated Total Lesions to Weeks 2, 4, 8 and 12
Hide Description 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.
Time Frame Baseline (Day 1) up to Week 2, 4, 8, 12
Hide Outcome Measure Data
Hide Analysis Population Description
MITT population. Only those participants available at the indicated time points were analyzed.
Arm/Group Title DUAC® SKINOREN®
Hide Arm/Group Description:
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.
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
Overall Number of Participants Analyzed 107 108
Mean (Standard Deviation)
Unit of Measure: Lesions
IL, WEEK 2 Number Analyzed 105 participants 108 participants
-10.3  (8.3) -6.3  (7.8)
IL, WEEK 4 Number Analyzed 105 participants 107 participants
-14.2  (9.1) -9.7  (8.6)
IL, WEEK 8 Number Analyzed 104 participants 102 participants
-17.7  (9.7) -12.7  (8.6)
IL, WEEK 12 Number Analyzed 107 participants 104 participants
-19.6  (10.1) -14.2  (8.9)
NIL, WEEK 2 Number Analyzed 105 participants 108 participants
-13.7  (19.0) -8.5  (13.3)
NIL, WEEK 4 Number Analyzed 105 participants 107 participants
-21.2  (21.5) -16.0  (19.1)
NIL, WEEK 8 Number Analyzed 104 participants 102 participants
-26.8  (27.1) -20.9  (23.6)
NIL, WEEK 12 Number Analyzed 107 participants 104 participants
-32.0  (27.2) -23.3  (24.9)
Total lesion, Week 2 Number Analyzed 105 participants 108 participants
-23.9  (22.3) -14.8  (16.7)
Total lesion, Week 4 Number Analyzed 105 participants 107 participants
-35.4  (25.0) -25.7  (22.3)
Total lesion, Week 8 Number Analyzed 104 participants 102 participants
-44.4  (31.3) -33.6  (27.5)
Total lesion, Week 12 Number Analyzed 107 participants 104 participants
-51.6  (30.9) -37.5  (29.0)
3.Secondary Outcome
Title Percentage Change From Baseline in IL, NIL and Calculated Total Lesions at Weeks 2, 4, 8 and 12
Hide Description 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.
Time Frame Baseline (Day 1) up to Week 2, 4, 8, 12
Hide Outcome Measure Data
Hide Analysis Population Description
MITT population. Only those participants available at the indicated time points were analyzed.
Arm/Group Title DUAC® SKINOREN®
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 107 108
Mean (Standard Deviation)
Unit of Measure: Percent change
IL, Week 2 Number Analyzed 105 participants 108 participants
-37.3  (27.7) -24.2  (30.3)
IL, Week 4 Number Analyzed 105 participants 107 participants
-52.2  (27.7) -38.1  (31.1)
IL, Week 8 Number Analyzed 104 participants 102 participants
-65.0  (26.3) -49.1  (30.9)
IL, Week 12 Number Analyzed 107 participants 104 participants
-72.3  (25.0) -55.0  (29.8)
NIL, Week 2 Number Analyzed 105 participants 108 participants
-23.5  (25.3) -14.9  (23.4)
NIL, Week 4 Number Analyzed 105 participants 107 participants
-38.1  (27.8) -27.0  (28.2)
NIL, Week 8 Number Analyzed 104 participants 102 participants
-48.5  (39.8) -35.5  (31.2)
NIL, Week 12 Number Analyzed 107 participants 104 participants
-60.6  (35.3) -42.1  (37.5)
Total lesions, Week 2 Number Analyzed 105 participants 108 participants
-28.7  (22.3) -18.4  (20.3)
Total lesions, Week 4 Number Analyzed 105 participants 107 participants
-43.8  (23.3) -30.8  (23.0)
Total lesions, Week 8 Number Analyzed 104 participants 102 participants
-55.2  (30.5) -40.1  (27.4)
Total lesions, Week 12 Number Analyzed 107 participants 104 participants
-64.6  (26.9) -46.1  (31.8)
4.Secondary Outcome
Title Speed of Onset : Time to 50 Percent Reduction in Total Lesion Count
Hide Description 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.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
MITT population. Only those participants available at the indicated time points were analyzed.
Arm/Group Title DUAC® SKINOREN®
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 91 60
Median (Full Range)
Unit of Measure: Days
52.0
(11.0 to 104.0)
55.0
(12.0 to 97.0)
5.Secondary Outcome
Title Number of Participants With Change From Baseline in Investigator’s Static Global Assessment (ISGA) to Weeks 2,4,8 and 12
Hide Description 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.
Time Frame Baseline (Day 1) up to Weeks 2, 4, 8, 12
Hide Outcome Measure Data
Hide Analysis Population Description
MITT population.
Arm/Group Title DUAC® SKINOREN®
Hide Arm/Group Description:
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.
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
Overall Number of Participants Analyzed 107 108
Measure Type: Count of Participants
Unit of Measure: Participants
Mild (Baseline) to Almost Clear (Week 2)
4
   3.7%
1
   0.9%
Mild (Baseline) to Moderate (Week 2)
3
   2.8%
8
   7.4%
Moderate (Baseline) to Almost Clear (Week 2)
1
   0.9%
1
   0.9%
Moderate (Baseline) to Mild (Week 2)
26
  24.3%
14
  13.0%
Moderate (Baseline) to Missing (Week 2)
2
   1.9%
0
   0.0%
Mild (Baseline) to Almost Clear (Week 4)
8
   7.5%
8
   7.4%
Mild (Baseline) to Moderate (Week 4)
1
   0.9%
4
   3.7%
Mild (Baseline) to Missing (Week 4)
0
   0.0%
1
   0.9%
Moderate (Baseline) to Almost Clear (Week 4)
11
  10.3%
3
   2.8%
Moderate (Baseline) to Mild (Week 4)
29
  27.1%
24
  22.2%
Moderate (Baseline) to Severe (Week 4)
0
   0.0%
1
   0.9%
Moderate (Baseline) to Missing (Week 4)
2
   1.9%
0
   0.0%
Mild (Baseline) to Clear (Week 8)
2
   1.9%
0
   0.0%
Mild (Baseline) to Almost Clear (Week 8)
10
   9.3%
10
   9.3%
Mild (Baseline) to Moderate (Week 8)
3
   2.8%
8
   7.4%
Mild (Baseline) to Missing (Week 8)
0
   0.0%
4
   3.7%
Moderate (Baseline) to Clear (Week 8)
1
   0.9%
0
   0.0%
Moderate (Baseline) to Almost Clear (Week 8)
15
  14.0%
5
   4.6%
Moderate (Baseline) To Mild (Week 8)
32
  29.9%
27
  25.0%
Moderate (Baseline) to Missing (Week 8)
3
   2.8%
2
   1.9%
Mild (Baseline) to Clear (Week 12)
3
   2.8%
1
   0.9%
Mild (Baseline) to Almost Clear (Week 12)
12
  11.2%
9
   8.3%
Mild (Baseline) to Moderate (Week 12)
2
   1.9%
8
   7.4%
Mild (Baseline) to Missing (Week 12)
0
   0.0%
2
   1.9%
Moderate (Baseline) to Clear (Week 12)
2
   1.9%
0
   0.0%
Moderate (Baseline) to Almost Clear (Week 12)
19
  17.8%
9
   8.3%
Moderate (Baseline) to Mild (Week 12)
33
  30.8%
26
  24.1%
Moderate (Baseline) to Severe (Week 12)
0
   0.0%
2
   1.9%
Moderate (Baseline) to Missing (Week 12)
0
   0.0%
2
   1.9%
6.Secondary Outcome
Title Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Hide Description 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.
Time Frame Baseline (Day 1) and Weeks 2, 4, 8, 12
Hide Outcome Measure Data
Hide Analysis Population Description
MITT population.
Arm/Group Title DUAC® SKINOREN®
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 107 108
Measure Type: Count of Participants
Unit of Measure: Participants
Erythema None (Baseline) To Slight (Week 2)
11
  10.3%
18
  16.7%
Erythema None (Baseline) To Some (Week 2)
0
   0.0%
1
   0.9%
Erythema None (Baseline) To Missing (Week 2)
1
   0.9%
0
   0.0%
Erythema Slight (Basline) To None (Week 2)
12
  11.2%
12
  11.1%
Erythema Slight (Baseline) To Some (Week 2)
1
   0.9%
8
   7.4%
Erythema Slight (Baseline) To Missing (Week 2)
1
   0.9%
0
   0.0%
Erythema Some (Baseline) To None (Week 2)
3
   2.8%
1
   0.9%
Erythema Some (Baseline) To Slight (Week 2)
10
   9.3%
11
  10.2%
Erythema Very Red (Baseline) To Slight (Week 2)
1
   0.9%
1
   0.9%
Erythema Very Red (Baseline) To Some (Week 2)
2
   1.9%
2
   1.9%
Erythema Missing (Baseline) To None (Week 2)
1
   0.9%
0
   0.0%
Erythema None (Baseline) To Slight (Week 4)
9
   8.4%
13
  12.0%
Erythema None (Baseline) To Some (Week 4)
1
   0.9%
3
   2.8%
Erythema None (Baseline) To Missing (Week 4)
1
   0.9%
0
   0.0%
Erythema Slight (Baseline) To None (Week 4)
18
  16.8%
19
  17.6%
Erythema Slight (Baseline) To Some (Week 4)
3
   2.8%
1
   0.9%
Erythema Slight (Baseline) To Missing (Week 4)
1
   0.9%
1
   0.9%
Erythema Some (Baseline) To None (Week 4)
5
   4.7%
3
   2.8%
Erythema Some (Baseline) To Slight (Week 4)
11
  10.3%
9
   8.3%
Erythema Some (Baseline) To Missing (Week 4)
0
   0.0%
1
   0.9%
Erythema Very Red (Baseline) To Slight (Week 4)
2
   1.9%
2
   1.9%
Erythema Very Red (Baseline) To Some (Week 4)
1
   0.9%
1
   0.9%
Erythema Missing (Baseline) To None (Week 4)
1
   0.9%
0
   0.0%
Erythema None (Baseline) To Slight (Week 8)
10
   9.3%
19
  17.6%
Erythema None (Baseline) To Some (Week 8)
0
   0.0%
2
   1.9%
Erythema None (Baseline) To Missing (Week 8)
1
   0.9%
2
   1.9%
Erythema Slight (Baseline) To None (Week 8)
15
  14.0%
17
  15.7%
Erythema Slight (Baseline) To Some (Week 8)
5
   4.7%
1
   0.9%
Erythema Slight (Baseline) To Missing (Week 8)
2
   1.9%
3
   2.8%
Erythema Some (Baseline) To None (Week 8)
8
   7.5%
1
   0.9%
Erythema Some (Baseline) To Slight (Week 8)
9
   8.4%
12
  11.1%
Erythema Some (Baseline) To Very Red (Week 8)
1
   0.9%
0
   0.0%
Erythema Some (Baseline) To Missing (Week 8)
0
   0.0%
1
   0.9%
Erythema Very Red (Baseline) To None (Week 8)
2
   1.9%
0
   0.0%
Erythema Very Red (Baseline) To Slight (Week 8)
1
   0.9%
3
   2.8%
Erythema Missing (Baseline) To Slight (Week 8)
1
   0.9%
0
   0.0%
Erythema None (Baseline) To Slight (Week 12)
6
   5.6%
18
  16.7%
Erythema None (Baseline) To Missing (Week 12)
0
   0.0%
2
   1.9%
Erythema Slight (Baseline) To None (Week 12)
21
  19.6%
22
  20.4%
Erythema Slight (Baseline) To Some (Week 12)
0
   0.0%
2
   1.9%
Erythema Slight (Baseline) To Very Red (Week 8)
1
   0.9%
0
   0.0%
Erythema Slight (Baseline) To Missing (Week 12)
0
   0.0%
1
   0.9%
Erythema Some (Baseline) To None (Week 12)
9
   8.4%
4
   3.7%
Erythema Some (Baseline) To Slight (Week 12)
8
   7.5%
9
   8.3%
Erythema Some (Baseline) To Missing (Week 12)
0
   0.0%
1
   0.9%
Erythema Very Red (Baseline) To None (Week 12)
0
   0.0%
2
   1.9%
Erythema Very Red (Baseline) To Slight (Week 12)
1
   0.9%
1
   0.9%
Erythema Missing (Baseline) To Slight (Week 12)
1
   0.9%
0
   0.0%
Peeling None (Baseline) To Slight (Week 2)
13
  12.1%
11
  10.2%
Peeling None (Baseline) To Moderate (Week 2)
1
   0.9%
0
   0.0%
Peeling None (Baseline) To Missing (Week 2)
2
   1.9%
0
   0.0%
Peeling Slight (Baseline) To None (Week 2)
8
   7.5%
8
   7.4%
Peeling Slight (Baseline) To Moderate (Week 2)
3
   2.8%
2
   1.9%
Peeling Moderate (Baseline) To None (Week 2)
2
   1.9%
0
   0.0%
Peeling Moderate (Baseline) To Slight (Week 2)
2
   1.9%
1
   0.9%
Peeling Missing (Baseline) To None (Week 2)
1
   0.9%
0
   0.0%
Peeling None (Baseline) To Slight (Week 4)
9
   8.4%
11
  10.2%
Peeling None (Baseline) To Missing (Week 4)
2
   1.9%
1
   0.9%
Peeling Slight (Baseline) To None (Week 4)
15
  14.0%
13
  12.0%
Peeling Slight (Baseline) To Moderate (Week 4)
1
   0.9%
1
   0.9%
Peeling Moderate (Baseline) To None (Week 4)
2
   1.9%
1
   0.9%
Peeling Moderate (Baseline) To Slight (Week 4)
1
   0.9%
0
   0.0%
Peeling Missing (Baseline) To None (Week 4)
1
   0.9%
0
   0.0%
Peeling None (Baseline) To Slight (Week 8)
9
   8.4%
10
   9.3%
Peeling None (Baseline) To Missing (Week 8)
3
   2.8%
5
   4.6%
Peeling Slight (Baseline) To None (Week 8)
18
  16.8%
12
  11.1%
Peeling Slight (Baseline) To Missing (Week 8)
0
   0.0%
1
   0.9%
Peeling Moderate (Baseline) To None (Week 8)
3
   2.8%
1
   0.9%
Peeling Moderate (Baseline) To Slight (Week 8)
1
   0.9%
0
   0.0%
Peeling Missing (Baseline) To None (Week 8)
1
   0.9%
0
   0.0%
Peeling None (Baseline) To Slight (Week 12)
7
   6.5%
11
  10.2%
Peeling None (Baseline) To Missing (Week 12)
0
   0.0%
3
   2.8%
Peeling Slight (Baseline) To None (Week 12)
14
  13.1%
15
  13.9%
Peeling Slight (Baseline) To Missing (Week 12)
0
   0.0%
1
   0.9%
Peeling Moderate (Baseline) To None (Week 12)
2
   1.9%
0
   0.0%
Peeling Moderate (Baseline) To Slight (Week 12)
2
   1.9%
1
   0.9%
Peeling Missing (Baseline) To None (Week 12)
1
   0.9%
0
   0.0%
Dryness None (Baseline) To Slight (Week 2)
14
  13.1%
9
   8.3%
Dryness None (Baseline) To Some (Week 2)
1
   0.9%
3
   2.8%
Dryness None (Baseline) To Missing (Week 2)
2
   1.9%
0
   0.0%
Dryness Slight (Baseline) To None (Week 2)
11
  10.3%
7
   6.5%
Dryness Slight (Baseline) To Some (Week 2)
3
   2.8%
6
   5.6%
Dryness Some (Baseline) To None (Week 2)
4
   3.7%
2
   1.9%
Dryness Some (Baseline) To Slight (Week 2)
1
   0.9%
2
   1.9%
Dryness Missing (Baseline) To None (Week 2)
1
   0.9%
0
   0.0%
Dryness None (Baseline) To Slight (Week 4)
9
   8.4%
12
  11.1%
Dryness None (Baseline) To Missing (Week 4)
2
   1.9%
1
   0.9%
Dryness Slight (Baseline) To None (Week 4)
14
  13.1%
10
   9.3%
Dryness Slight (Baseline) To Some (Week 4)
2
   1.9%
3
   2.8%
Dryness Some (Baseline) To None (Week 4)
4
   3.7%
1
   0.9%
Dryness Some (Baseline) To Slight (Week 4)
3
   2.8%
5
   4.6%
Dryness Missing (Baseline) To None (Week 4)
1
   0.9%
0
   0.0%
Dryness None (Baseline) To Slight (Week 8)
8
   7.5%
11
  10.2%
Dryness None (Baseline) To Missing (Week 8)
3
   2.8%
5
   4.6%
Dryness Slight (Baseline) To None (Week 8)
19
  17.8%
12
  11.1%
Dryness Slight (Baseline) To Some (Week 8)
0
   0.0%
1
   0.9%
Dryness Slight (Baseline) To Missing (Week 8)
0
   0.0%
1
   0.9%
Dryness Some (Baseline) To None (Week 8)
5
   4.7%
1
   0.9%
Dryness Some (Baseline) To Slight (Week 8)
4
   3.7%
5
   4.6%
Dryness Missing (Baseline) To None (Week 8)
1
   0.9%
0
   0.0%
Dryness None (Baseline) To Some (Week 12)
1
   0.9%
0
   0.0%
Dryness None (Baseline) To Slight (Week 12)
2
   1.9%
8
   7.4%
Dryness None (Baseline) To Missing (Week 12)
0
   0.0%
3
   2.8%
Dryness Slight (Baseline) To None (Week 12)
14
  13.1%
15
  13.9%
Dryness Slight (Baseline) To Some (Week 12)
0
   0.0%
1
   0.9%
Dryness Slight (Baseline) To Missing (Week 12)
0
   0.0%
1
   0.9%
Dryness Some (Baseline) To None (Week 12)
6
   5.6%
3
   2.8%
Dryness Some (Baseline) To Slight (Week 12)
3
   2.8%
3
   2.8%
Dryness Missing (Baseline) To None (Week 12)
1
   0.9%
0
   0.0%
7.Secondary Outcome
Title Number of Participants With Participant Global Change Assessment Score 12 Weeks
Hide Description 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.
Time Frame Weeks 2, 4, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
MITT population.
Arm/Group Title DUAC® SKINOREN®
Hide Arm/Group Description:
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.
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
Overall Number of Participants Analyzed 107 108
Measure Type: Count of Participants
Unit of Measure: Participants
Very much improved (Week 2)
4
   3.7%
2
   1.9%
Much improved (Week 2)
51
  47.7%
30
  27.8%
Minimally improved (Week 2)
44
  41.1%
56
  51.9%
No change (Week 2)
6
   5.6%
14
  13.0%
Minimally worse (Week 2)
0
   0.0%
6
   5.6%
Missing (Week 2)
2
   1.9%
0
   0.0%
Very much improved (Week 4)
5
   4.7%
0
   0.0%
Much improved (Week 4)
48
  44.9%
39
  36.1%
Minimally improved (Week 4)
44
  41.1%
49
  45.4%
No change (Week 4)
2
   1.9%
12
  11.1%
Minimally worse (Week 4)
6
   5.6%
7
   6.5%
Missing (Week 4)
2
   1.9%
1
   0.9%
Very much improved (Week 8)
9
   8.4%
1
   0.9%
Much improved (Week 8)
54
  50.5%
44
  40.7%
Minimally improved (Week 8)
30
  28.0%
32
  29.6%
No change (Week 8)
7
   6.5%
15
  13.9%
Minimally worse (Week 8)
3
   2.8%
8
   7.4%
Much worse (Week 8)
1
   0.9%
1
   0.9%
Very much worse (Week 8)
0
   0.0%
1
   0.9%
Missing (Week 8)
3
   2.8%
6
   5.6%
Very much improved (Week 12)
14
  13.1%
8
   7.4%
Much improved (Week 12)
48
  44.9%
38
  35.2%
Minimally improved (Week 12)
29
  27.1%
33
  30.6%
No change (Week 12)
10
   9.3%
17
  15.7%
Minimally worse (Week 12)
4
   3.7%
5
   4.6%
Much worse (Week 12)
0
   0.0%
2
   1.9%
Very much worse (Week 12)
2
   1.9%
1
   0.9%
Missing (Week 12)
0
   0.0%
4
   3.7%
8.Secondary Outcome
Title Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
Hide Description 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.
Time Frame Baseline (Day 1), Weeks 2, 4, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
MITT population.
Arm/Group Title DUAC® SKINOREN®
Hide Arm/Group Description:
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.
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
Overall Number of Participants Analyzed 107 108
Measure Type: Count of Participants
Unit of Measure: Participants
S/B None (Baseline) To Slight (Week 2)
14
  13.1%
23
  21.3%
S/B None (Baseline) To Moderate (Week 2)
4
   3.7%
8
   7.4%
S/B None (Baseline) To Strong (Week 2)
1
   0.9%
4
   3.7%
S/B None (Baseline) To Missing (Week 2)
2
   1.9%
0
   0.0%
S/B Slight (Baseline) To None (Week 2)
14
  13.1%
10
   9.3%
S/B Slight (Baseline) To Moderate (Week 2)
3
   2.8%
2
   1.9%
S/B Slight (Baseline) To Strong (Week 2)
0
   0.0%
2
   1.9%
S/B Moderate (Baseline) To None (Week 2)
0
   0.0%
1
   0.9%
S/B Moderate (Baseline) To Slight (Week 2)
1
   0.9%
3
   2.8%
S/B Strong (Baseline) To None (Week 2)
0
   0.0%
1
   0.9%
S/B Missing (Baseline) To None (Week 2)
1
   0.9%
0
   0.0%
S/B None (Baseline) To Slight (Week 4)
11
  10.3%
29
  26.9%
S/B None (Baseline) To Moderate (Week 4)
1
   0.9%
6
   5.6%
S/B None (Baseline) To Missing (Week 4)
2
   1.9%
1
   0.9%
S/B Slight (Baseline) To None (Week 4)
12
  11.2%
9
   8.3%
S/B Slight (Baseline) To Moderate (Week 4)
1
   0.9%
1
   0.9%
S/B Slight (Baseline) To Strong (Week 4)
0
   0.0%
1
   0.9%
S/B Moderate (Baseline) To None (Week 4)
0
   0.0%
2
   1.9%
S/B Moderate (Baseline) To Slight (Week 4)
1
   0.9%
3
   2.8%
S/B Moderate (Baseline) To Strong (Week 4)
0
   0.0%
1
   0.9%
S/B Strong (Baseline) To None (Week 4)
0
   0.0%
1
   0.9%
S/B Missing (Baseline) To Slight (Week 4)
1
   0.9%
0
   0.0%
S/B None (Baseline) To Slight (Week 8)
5
   4.7%
21
  19.4%
S/B None (Baseline) To Moderate (Week 8)
1
   0.9%
4
   3.7%
S/B None (Baseline) To Missing (Week 8)
3
   2.8%
5
   4.6%
S/B None (Baseline) To Strong (Week 8)
0
   0.0%
1
   0.9%
S/B Slight (Baseline) To None (Week 8)
18
  16.8%
10
   9.3%
S/B Slight (Baseline) To Moderate (Week 8)
1
   0.9%
1
   0.9%
S/B Slight (Baseline) To Strong (Week 8)
0
   0.0%
1
   0.9%
S/B Moderate (Baseline) To None (Week 8)
0
   0.0%
1
   0.9%
S/B Moderate (Baseline) To Slight (Week 8)
1
   0.9%
2
   1.9%
S/B Moderate (Baseline) To Missing (Week 8)
0
   0.0%
1
   0.9%
S/B Strong (Baseline) To None (Week 8)
0
   0.0%
1
   0.9%
S/B Missing (Baseline) To None (Week 8)
1
   0.9%
0
   0.0%
S/B None (Baseline) To Slight (Week 12)
6
   5.6%
19
  17.6%
S/B None (Baseline) To Moderate (Week 12)
1
   0.9%
5
   4.6%
S/B None (Baseline) To Strong (Week 12)
1
   0.9%
2
   1.9%
S/B None (Baseline) To Missing (Week 12)
1
   0.9%
4
   3.7%
S/B Slight (Baseline) To None (Week 12)
18
  16.8%
9
   8.3%
S/B Slight (Baseline) To Moderate (Week 12)
0
   0.0%
3
   2.8%
S/B Slight (Baseline) To Strong (Week 12)
0
   0.0%
1
   0.9%
S/B Moderate (Baseline) To None (Week 12)
1
   0.9%
2
   1.9%
S/B Moderate (Baseline) To Slight (Week 12)
0
   0.0%
3
   2.8%
S/B Strong (Baseline) To Slight (Week 12)
0
   0.0%
1
   0.9%
S/B Missing (Baseline) To None (Week 12)
1
   0.9%
0
   0.0%
Pruritus None (Baseline) To Slight (Week 2)
14
  13.1%
27
  25.0%
Pruritus None (Baseline) To Moderate (Week 2)
4
   3.7%
7
   6.5%
Pruritus None (Baseline) To Strong (Week 2)
0
   0.0%
1
   0.9%
Pruritus None (Baseline) To Missing (Week 2)
2
   1.9%
0
   0.0%
Pruritus Slight (Baseline) To None (Week 2)
13
  12.1%
10
   9.3%
Pruritus Slight (Baseline) To Moderate (Week 2)
5
   4.7%
9
   8.3%
Pruritus Slight (Baseline) To Strong (Week 2)
1
   0.9%
4
   3.7%
Pruritus Moderate (Baseline) To None (Week 2)
2
   1.9%
4
   3.7%
Pruritus Moderate (Baseline) To Slight (Week 2)
1
   0.9%
1
   0.9%
Pruritus Missing (Baseline) To None (Week 2)
1
   0.9%
0
   0.0%
Pruritus None (Baseline) To Slight (Week 4)
14
  13.1%
30
  27.8%
Pruritus None (Baseline) To Moderate (Week 4)
2
   1.9%
5
   4.6%
Pruritus None (Baseline) To Missing (Week 4)
2
   1.9%
1
   0.9%
Pruritus Slight (Baseline) To None (Week 4)
17
  15.9%
12
  11.1%
Pruritus Slight (Baseline) To Moderate (Week 4)
2
   1.9%
6
   5.6%
Pruritus Slight (Baseline) To Strong (Week 4)
0
   0.0%
1
   0.9%
Pruritus Moderate (Baseline) To None (Week 4)
2
   1.9%
2
   1.9%
Pruritus Moderate (Baseline) To Slight (Week 4)
2
   1.9%
2
   1.9%
Pruritus Missing (Baseline) To None (Week 4)
1
   0.9%
0
   0.0%
Pruritus None (Baseline) To Slight (Week 8)
13
  12.1%
26
  24.1%
Pruritus None (Baseline) To Missing (Week 8)
3
   2.8%
3
   2.8%
Pruritus None (Baseline) To Strong (Week 8)
0
   0.0%
1
   0.9%
Pruritus Slight (Baseline) To None (Week 8)
21
  19.6%
11
  10.2%
Pruritus Slight (Baseline) To Moderate (Week 8)
4
   3.7%
4
   3.7%
Pruritus Slight (Baseline) To Strong (Week 8)
0
   0.0%
2
   1.9%
Pruritus Slight (Baseline) To Missing (Week 8)
0
   0.0%
3
   2.8%
Pruritus Moderate (Baseline) To None (Week 8)
3
   2.8%
2
   1.9%
Pruritus Moderate (Baseline) To Slight (Week 8)
1
   0.9%
3
   2.8%
Pruritus Strong (Baseline) To Moderate (Week 8)
0
   0.0%
1
   0.9%
Pruritus Missing (Baseline) To None (Week 8)
1
   0.9%
0
   0.0%
Pruritus None (Baseline) To Slight (Week 12)
11
  10.3%
22
  20.4%
Pruritus None (Baseline) To Moderate (Week 12)
1
   0.9%
3
   2.8%
Pruritus None (Baseline) To Strong (Week 12)
0
   0.0%
1
   0.9%
Pruritus None (Baseline) To Missing (Week 12)
0
   0.0%
4
   3.7%
Pruritus Slight (Baseline) To None (Week 12)
22
  20.6%
11
  10.2%
Pruritus Slight (Baseline) To Moderate (Week 12)
2
   1.9%
6
   5.6%
Pruritus Slight (Baseline) To Strong (Week 12)
0
   0.0%
2
   1.9%
Pruritus Moderate (Baseline) To None (Week 12)
3
   2.8%
1
   0.9%
Pruritus Moderate (Baseline) To Slight (Week 12)
1
   0.9%
4
   3.7%
Pruritus Strong (Baseline) To Slight (Week 12)
0
   0.0%
1
   0.9%
Pruritus Missing (Baseline) To None (Week 12)
1
   0.9%
0
   0.0%
9.Secondary Outcome
Title Number of Participants With Participant Satisfaction Score at Week 12 (Simple Grading)
Hide Description 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).
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
MITT population.
Arm/Group Title DUAC® SKINOREN®
Hide Arm/Group Description:
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.
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
Overall Number of Participants Analyzed 107 108
Measure Type: Count of Participants
Unit of Measure: Participants
Redness, None
55
  51.4%
47
  43.5%
Redness, Very minimal
32
  29.9%
20
  18.5%
Redness, Mild
8
   7.5%
17
  15.7%
Redness, Moderate
9
   8.4%
13
  12.0%
Redness, Severe
2
   1.9%
5
   4.6%
Redness, Very severe
1
   0.9%
2
   1.9%
Redness, Not applicable
0
   0.0%
1
   0.9%
Dryness, None
43
  40.2%
41
  38.0%
Dryness, Very minimal
32
  29.9%
28
  25.9%
Dryness, Mild
20
  18.7%
24
  22.2%
Dryness, Moderate
9
   8.4%
7
   6.5%
Dryness, Severe
2
   1.9%
2
   1.9%
Dryness, Very severe
1
   0.9%
2
   1.9%
Dryness, Not applicable
0
   0.0%
1
   0.9%
Burning, None
90
  84.1%
50
  46.3%
Burning, Very minimal
8
   7.5%
28
  25.9%
Burning, Mild
5
   4.7%
12
  11.1%
Burning, Moderate
3
   2.8%
9
   8.3%
Burning, Severe
1
   0.9%
5
   4.6%
Burning, Very severe
0
   0.0%
0
   0.0%
Burning, Not applicable
0
   0.0%
1
   0.9%
Itching, None
73
  68.2%
38
  35.2%
Itching, Very minimal
17
  15.9%
30
  27.8%
Itching, Mild
10
   9.3%
20
  18.5%
Itching, Moderate
6
   5.6%
11
  10.2%
Itching, Severe
1
   0.9%
3
   2.8%
Itching, Very severe
0
   0.0%
2
   1.9%
Itching, Not applicable
0
   0.0%
1
   0.9%
Scaling, None
69
  64.5%
77
  71.3%
Scaling, Very minimal
24
  22.4%
9
   8.3%
Scaling, Mild
7
   6.5%
7
   6.5%
Scaling, Moderate
2
   1.9%
7
   6.5%
Scaling, Severe
4
   3.7%
4
   3.7%
Scaling, Very severe
1
   0.9%
0
   0.0%
Scaling, Not applicable
0
   0.0%
1
   0.9%
10.Secondary Outcome
Title Number of Treatment Adherent Participants at Week 12
Hide Description 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).
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
MITT population.
Arm/Group Title DUAC® SKINOREN®
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 107 108
Measure Type: Count of Participants
Unit of Measure: Participants
Very satisfied
41
  38.3%
26
  24.1%
Satisfied
61
  57.0%
43
  39.8%
Neutral
4
   3.7%
21
  19.4%
Unsatisfied
1
   0.9%
11
  10.2%
Very unsatisfied
0
   0.0%
3
   2.8%
11.Secondary Outcome
Title Absolute Change From Baseline in Total Score as Per Dermatology Life Quality Index (DLQI) at Week 2,4,8 and 12
Hide Description 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.
Time Frame Baseline (Day 1) up to Weeks 2, 4, 8, 12
Hide Outcome Measure Data
Hide Analysis Population Description
MITT population. Only those participants available at the indicated time points were analyzed.
Arm/Group Title DUAC® SKINOREN®
Hide Arm/Group Description:
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.
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
Overall Number of Participants Analyzed 62 61
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Week 2 Number Analyzed 54 participants 53 participants
-2.28  (2.81) -2.17  (3.72)
Week 4 Number Analyzed 56 participants 52 participants
-3.39  (3.33) -3.15  (3.52)
Week 8 Number Analyzed 55 participants 50 participants
-4.04  (3.70) -3.38  (4.60)
Week 12 Number Analyzed 57 participants 51 participants
-4.46  (3.80) -3.12  (4.94)
12.Secondary Outcome
Title Absolute Change From Baseline in Total Score as Per Children’s Dermatology Life Quality Index (CDLQI) at Week 2,4,8 and 12
Hide Description 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.
Time Frame Baseline (Day 1) up to Weeks 2, 4, 8, 12
Hide Outcome Measure Data
Hide Analysis Population Description
MITT population. Only those participants available at the indicated time points were analyzed.
Arm/Group Title DUAC® SKINOREN®
Hide Arm/Group Description:
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.
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
Overall Number of Participants Analyzed 38 42
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Week 2 -2.61  (2.89) -1.31  (2.29)
Week 4 -2.55  (2.41) -1.55  (2.01)
Week 8 -2.68  (2.76) -1.67  (2.34)
Week 12 -2.87  (2.75) -1.55  (2.56)
13.Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs) Related to Study Medication
Hide Description 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.
Time Frame Up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title DUAC® SKINOREN®
Hide Arm/Group Description:
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.
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
Overall Number of Participants Analyzed 108 109
Measure Type: Count of Participants
Unit of Measure: Participants
TEAE
60
  55.6%
76
  69.7%
TESAE
2
   1.9%
3
   2.8%
TEAEs related to the study drug
15
  13.9%
36
  33.0%
TESAEs related to the study drug
0
   0.0%
0
   0.0%
Time Frame Adverse events and serious adverse events were collected up to Week 12.
Adverse Event Reporting Description Intent-to-treat population consisted of all participants who were randomized and who used the test medication at least once.
 
Arm/Group Title DUAC® SKINOREN®
Hide Arm/Group Description 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 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
All-Cause Mortality
DUAC® SKINOREN®
Affected / at Risk (%) Affected / at Risk (%)
Total   0/108 (0.00%)   0/109 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
DUAC® SKINOREN®
Affected / at Risk (%) Affected / at Risk (%)
Total   2/108 (1.85%)   3/109 (2.75%) 
Infections and infestations     
Brucellosis  1  1/108 (0.93%)  0/109 (0.00%) 
Gastroenteritis  1  0/108 (0.00%)  1/109 (0.92%) 
Metabolism and nutrition disorders     
Type 1 diabetes mellitus  1  0/108 (0.00%)  1/109 (0.92%) 
Psychiatric disorders     
Stress  1  1/108 (0.93%)  0/109 (0.00%) 
Renal and urinary disorders     
Urinary retention  1  0/108 (0.00%)  1/109 (0.92%) 
Reproductive system and breast disorders     
Vulval haematoma  1  1/108 (0.93%)  0/109 (0.00%) 
1
Term from vocabulary, MedDRA
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
DUAC® SKINOREN®
Affected / at Risk (%) Affected / at Risk (%)
Total   32/108 (29.63%)   55/109 (50.46%) 
General disorders     
Application site pain  1  7/108 (6.48%)  22/109 (20.18%) 
Application site pruritus  1  8/108 (7.41%)  25/109 (22.94%) 
Infections and infestations     
Nasopharyngitis  1  10/108 (9.26%)  20/109 (18.35%) 
Nervous system disorders     
Headache  1  16/108 (14.81%)  18/109 (16.51%) 
1
Term from vocabulary, MedDRA
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02058628     History of Changes
Other Study ID Numbers: 200398
First Submitted: February 6, 2014
First Posted: February 10, 2014
Results First Submitted: March 1, 2017
Results First Posted: August 25, 2017
Last Update Posted: August 25, 2017