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Comparative Antimicrobial Efficacy of Two Topical Acne Therapies for the Treatment of Facial Acne

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ClinicalTrials.gov Identifier: NCT00841776
Recruitment Status : Completed
First Posted : February 11, 2009
Results First Posted : July 23, 2010
Last Update Posted : May 25, 2017
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Acne
Interventions Drug: Duac
Drug: Ziana gel
Enrollment 54
Recruitment Details Clinical research center
Pre-assignment Details  
Arm/Group Title Duac Ziana
Hide Arm/Group Description Clindamycin and benzoyl peroxide topical gel Clindamycin and topical tretinoin gel
Period Title: Overall Study
Started 27 27
Completed 25 24
Not Completed 2 3
Reason Not Completed
Lack of Efficacy             0             1
Lost to Follow-up             2             1
Withdrawal by Subject             0             1
Arm/Group Title Duac Ziana Total
Hide Arm/Group Description Clindamycin and benzoyl peroxide topical gel Clindamycin and topical tretinoin gel Total of all reporting groups
Overall Number of Baseline Participants 27 27 54
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants 27 participants 54 participants
17.6  (6.9) 16.2  (4.9) 16.9  (6.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 27 participants 54 participants
Female
14
  51.9%
15
  55.6%
29
  53.7%
Male
13
  48.1%
12
  44.4%
25
  46.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 27 participants 27 participants 54 participants
Caucasian 21 22 43
Black 4 4 8
Hispanic 0 1 1
Other 2 0 2
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 27 participants 27 participants 54 participants
27 27 54
Acne Lesion Counts   [1] 
Mean (Standard Deviation)
Unit of measure:  Acne Lesion Counts
Number Analyzed 27 participants 27 participants 54 participants
Inflammatory Lesion Counts 24.74  (10.61) 22.78  (7.07) 23.76  (8.98)
Noninflammatory Lesion Counts 34.30  (20.38) 35.11  (15.40) 34.70  (17.90)
Total Lesion Counts 59.04  (23.68) 57.89  (19.99) 58.46  (21.72)
[1]
Measure Description: P. acne Lesion Counts
Clinidamycin-resistant propionibacterium acne (P.acne) counts   [1] 
Mean (Standard Deviation)
Unit of measure:  Clinidamycin-resistant p. acne counts
Number Analyzed 27 participants 27 participants 54 participants
2.29  (1.34) 2.02  (1.21) 2.16  (1.27)
[1]
Measure Description: Clinidamycin-resistant Colony Forming Unit Propionibacterium acne counts
Erythromycin-resistant lesion count   [1] 
Mean (Standard Deviation)
Unit of measure:  Erythromycin-resistant lesion count
Number Analyzed 27 participants 27 participants 54 participants
2.29  (1.37) 1.92  (1.11) 2.10  (1.25)
[1]
Measure Description: Erythromycin-resistant Colony forming Unit lesion count
Propionibacterium acne counts   [1] 
Mean (Standard Deviation)
Unit of measure:  P. acne counts
Number Analyzed 27 participants 27 participants 54 participants
4.63  (1.12) 4.74  (0.58) 4.69  (0.88)
[1]
Measure Description: Mean colony forming unit P. acne counts
1.Primary Outcome
Title Median Change in Total Propionibacterium Acne (P.Acne) Counts
Hide Description Median change in total colony forming units of propionibacterium acne (P.acne) will be counted.
Time Frame Baseline, Weeks 2, 4, 8, 12, & 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Duac Ziana
Hide Arm/Group Description:
Clindamycin and benzoyl peroxide topical gel
Clindamycin and topical tretinoin gel
Overall Number of Participants Analyzed 27 27
Median (Inter-Quartile Range)
Unit of Measure: P. acne counts
Change from Baseline to Week 2
-1.26
(-2.42 to -0.4)
-0.08
(-0.67 to 0.18)
Change from Baseline to Week 4
-1.58
(-2.27 to -0.61)
-0.67
(-1.31 to -0.04)
Change from Baseline to Week 8
-1.65
(-2.43 to -0.68)
-0.32
(-0.84 to 0.12)
Change from Baseline to Week 12
-1.82
(-3.62 to -1.0)
-0.59
(-1.07 to 0.07)
Change from Baseline to Week 16
-2.48
(-3.08 to -0.82)
-0.57
(-1.18 to -0.36)
2.Secondary Outcome
Title Median Change in Clindamycin Resistant P. Acne.
Hide Description Median change in total colony forming units of clindamycin resistant p. acne.
Time Frame Baseline, Weeks 2, 4, 8, 12, 16
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Duac Ziana
Hide Arm/Group Description:
Clindamycin and benzoyl peroxide topical gel
Clindamycin and topical tretinoin gel
Overall Number of Participants Analyzed 27 27
Median (Inter-Quartile Range)
Unit of Measure: Clindamycin- resistant P. acne counts
Change from Baseline to Week 2
-0.30
(-1.74 to 0)
0
(0 to 0.4)
Change from Baseline to Week 4
0
(-1.43 to 0)
0
(-0.51 to 0.12)
Change from Baseline to Week 8
-0.86
(-1.95 to 0)
0
(-0.10 to 0.60)
Change from Baseline to Week 12
-0.83
(-1.53 to 0)
0.39
(0 to 0.88)
Change from Baseline to Week 16
-0.30
(-1.84 to 0)
0
(-0.03 to 0.25)
3.Secondary Outcome
Title Median Change in Erythromycin-resistant P. Acne Counts
Time Frame Baseline, Weeks 2, 4, 8, 12, and 16
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Duac Ziana
Hide Arm/Group Description:
Clindamycin and benzoyl peroxide topical gel
Clindamycin and topical tretinoin gel
Overall Number of Participants Analyzed 27 27
Median (Inter-Quartile Range)
Unit of Measure: Erythromycin-resistant P. acne counts
Change from Baseline to Week 2
-0.36
(-1.67 to 0)
0
(0 to 0.56)
Change from Baseline to Week 4
-0.18
(-1.51 to 0)
0
(0 to 0.68)
Change from Baseline to Week 8
-0.83
(-2.26 to 0)
0
(0 to 0.40)
Change from Baseline to Week 12
-.91
(-1.68 to 0)
0.15
(0 to 0.88)
Change from Baseline to Week 16
0
(-1.81 to 0)
0.04
(0 to 0.48)
4.Secondary Outcome
Title Median Change in Total Acne Lesions
Hide Description Median Change in Total Acne Lesions
Time Frame Baseline, Weeks 2, 4, 8, 12, and 16
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Duac Ziana
Hide Arm/Group Description:
Clindamycin and benzoyl peroxide topical gel
Clindamycin and topical tretinoin gel
Overall Number of Participants Analyzed 27 27
Median (Inter-Quartile Range)
Unit of Measure: Total Acne Lesion Counts
Change from Baseline to Week 2
-14
(-22 to -4)
-13
(-23 to 2)
Change from Baseline to Week 4
-22
(-30 to -16)
-14
(-24 to -2)
Change from Baseline to Week 8
-27
(-38 to -9)
-19
(-36 to -5)
Change from Baseline to Week 12
-26.5
(-36 to -15)
-23.5
(-34 to -11)
Change from Baseline to Week 16
-33
(-35 to -22)
-30
(-41.5 to -17)
5.Secondary Outcome
Title Median Change in Inflammatory Acne Lesion Counts
Hide Description Median Change in Inflammatory Acne Lesion Counts
Time Frame Baseline, Weeks 2, 4, 8, 12, and 16
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Duac Ziana
Hide Arm/Group Description:
Clindamycin and benzoyl peroxide topical gel
Clindamycin and topical tretinoin gel
Overall Number of Participants Analyzed 27 27
Median (Inter-Quartile Range)
Unit of Measure: Lesion Counts
Change from Baseline to Week 2
-7
(-13 to -1)
-7
(-15 to -4)
Change from Baseline to Week 4
-12
(-18 to -3)
-7
(-15 to -1)
Change from Baseline to Week 8
-11
(-22 to -6)
-7
(-16 to -2)
Change from Baseline to Week 12
-12.5
(-19 to -7)
-10.5
(-17 to -5)
Change from Baseline to Week 16
-14
(-20 to -6)
-14
(-19 to -8)
6.Secondary Outcome
Title Median Change in Noninflammaotry Acne Counts
Hide Description Median Change in Noninflammaotry Acne Counts
Time Frame Baseline, Weeks 2, 4, 8, 12, and 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Duac Ziana
Hide Arm/Group Description:
Clindamycin and benzoyl peroxide topical gel
Clindamycin and topical tretinoin gel
Overall Number of Participants Analyzed 27 27
Median (Inter-Quartile Range)
Unit of Measure: Noninflammatory lesion counts
Change from Baseline to Week 2
-6
(-10 to 1)
-6
(-9 to 2)
Change from Baseline to Week 4
-10
(-23 to -3)
-8
(-18 to 1)
Change from Baseline to Week 8
-13
(-17 to -5)
-12
(-22 to 2)
Change from Baseline to Week 12
-9
(-25 to -4)
-13.5
(-18 to -2)
Change from Baseline to Week 16
-11
(-20 to -3)
-16.5
(-23 to -7.5)
Time Frame 16 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Duac Ziana
Hide Arm/Group Description Clindamycin and benzoyl peroxide topical gel Clindamycin and topical tretinoin gel
All-Cause Mortality
Duac Ziana
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Duac Ziana
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/27 (0.00%)      0/27 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Duac Ziana
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/27 (18.52%)      5/27 (18.52%)    
Infections and infestations     
Sinus Infection *  1/27 (3.70%)  1 1/27 (3.70%)  1
Gonorrhea *  1/27 (3.70%)  1 0/27 (0.00%)  0
Head Cold *  2/27 (7.41%)  3 1/27 (3.70%)  1
Oral Thrush *  1/27 (3.70%)  1 0/27 (0.00%)  0
Nervous system disorders     
Attention Deficit Disorder *  1/27 (3.70%)  1 0/27 (0.00%)  0
Skin and subcutaneous tissue disorders     
Oily skin on face *  0/27 (0.00%)  0 1/27 (3.70%)  1
Skin surgery * [1]  0/27 (0.00%)  0 2/27 (7.41%)  2
*
Indicates events were collected by non-systematic assessment
[1]
Surgery performed while on study
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.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier: NCT00841776     History of Changes
Other Study ID Numbers: DTG0703
First Submitted: February 10, 2009
First Posted: February 11, 2009
Results First Submitted: April 7, 2010
Results First Posted: July 23, 2010
Last Update Posted: May 25, 2017