Trial Outcomes & Findings for Comparative Antimicrobial Efficacy of Two Topical Acne Therapies for the Treatment of Facial Acne (NCT NCT00841776)

NCT ID: NCT00841776

Last Updated: 2017-05-25

Results Overview

Median change in total colony forming units of propionibacterium acne (P.acne) will be counted.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 54 participants
• Primary outcome timeframe: Baseline, Weeks 2, 4, 8, 12, & 16
• Results posted on: 2017-05-25

Participant Flow

Clinical research center

Participant milestones

Measure	Duac Clindamycin and benzoyl peroxide topical gel	Ziana Clindamycin and topical tretinoin gel
Overall Study STARTED	27	27
Overall Study COMPLETED	25	24
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Measure	Duac Clindamycin and benzoyl peroxide topical gel	Ziana Clindamycin and topical tretinoin gel
Overall Study Lack of Efficacy	0	1
Overall Study Lost to Follow-up	2	1
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Duac n=27 Participants Clindamycin and benzoyl peroxide topical gel	Ziana n=27 Participants Clindamycin and topical tretinoin gel	Total n=54 Participants Total of all reporting groups
Age, Continuous	17.6 years STANDARD_DEVIATION 6.9 • n=5 Participants	16.2 years STANDARD_DEVIATION 4.9 • n=7 Participants	16.9 years STANDARD_DEVIATION 6.0 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	21 Participants n=5 Participants	22 Participants n=7 Participants	43 Participants n=5 Participants
Race/Ethnicity, Customized Black	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants	27 participants n=7 Participants	54 participants n=5 Participants
Acne Lesion Counts Inflammatory Lesion Counts	24.74 Acne Lesion Counts STANDARD_DEVIATION 10.61 • n=5 Participants	22.78 Acne Lesion Counts STANDARD_DEVIATION 7.07 • n=7 Participants	23.76 Acne Lesion Counts STANDARD_DEVIATION 8.98 • n=5 Participants
Acne Lesion Counts Noninflammatory Lesion Counts	34.30 Acne Lesion Counts STANDARD_DEVIATION 20.38 • n=5 Participants	35.11 Acne Lesion Counts STANDARD_DEVIATION 15.40 • n=7 Participants	34.70 Acne Lesion Counts STANDARD_DEVIATION 17.90 • n=5 Participants
Acne Lesion Counts Total Lesion Counts	59.04 Acne Lesion Counts STANDARD_DEVIATION 23.68 • n=5 Participants	57.89 Acne Lesion Counts STANDARD_DEVIATION 19.99 • n=7 Participants	58.46 Acne Lesion Counts STANDARD_DEVIATION 21.72 • n=5 Participants
Clinidamycin-resistant propionibacterium acne (P.acne) counts	2.29 Clinidamycin-resistant p. acne counts STANDARD_DEVIATION 1.34 • n=5 Participants	2.02 Clinidamycin-resistant p. acne counts STANDARD_DEVIATION 1.21 • n=7 Participants	2.16 Clinidamycin-resistant p. acne counts STANDARD_DEVIATION 1.27 • n=5 Participants
Erythromycin-resistant lesion count	2.29 Erythromycin-resistant lesion count STANDARD_DEVIATION 1.37 • n=5 Participants	1.92 Erythromycin-resistant lesion count STANDARD_DEVIATION 1.11 • n=7 Participants	2.10 Erythromycin-resistant lesion count STANDARD_DEVIATION 1.25 • n=5 Participants
Propionibacterium acne counts	4.63 P. acne counts STANDARD_DEVIATION 1.12 • n=5 Participants	4.74 P. acne counts STANDARD_DEVIATION 0.58 • n=7 Participants	4.69 P. acne counts STANDARD_DEVIATION 0.88 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, & 16

Median change in total colony forming units of propionibacterium acne (P.acne) will be counted.

Outcome measures

Measure	Duac n=27 Participants Clindamycin and benzoyl peroxide topical gel	Ziana n=27 Participants Clindamycin and topical tretinoin gel
Median Change in Total Propionibacterium Acne (P.Acne) Counts Change from Baseline to Week 2	-1.26 P. acne counts Inter-Quartile Range 1.44 • Interval -2.42 to -0.4	-0.08 P. acne counts Inter-Quartile Range 0.82 • Interval -0.67 to 0.18
Median Change in Total Propionibacterium Acne (P.Acne) Counts Change from Baseline to Week 4	-1.58 P. acne counts Inter-Quartile Range 1.49 • Interval -2.27 to -0.61	-0.67 P. acne counts Inter-Quartile Range 1.18 • Interval -1.31 to -0.04
Median Change in Total Propionibacterium Acne (P.Acne) Counts Change from Baseline to Week 8	-1.65 P. acne counts Inter-Quartile Range 1.50 • Interval -2.43 to -0.68	-0.32 P. acne counts Inter-Quartile Range 1.04 • Interval -0.84 to 0.12
Median Change in Total Propionibacterium Acne (P.Acne) Counts Change from Baseline to Week 12	-1.82 P. acne counts Inter-Quartile Range 1.60 • Interval -3.62 to -1.0	-0.59 P. acne counts Inter-Quartile Range 0.99 • Interval -1.07 to 0.07
Median Change in Total Propionibacterium Acne (P.Acne) Counts Change from Baseline to Week 16	-2.48 P. acne counts Inter-Quartile Range 1.77 • Interval -3.08 to -0.82	-0.57 P. acne counts Inter-Quartile Range 0.83 • Interval -1.18 to -0.36

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16

Population: ITT

Median change in total colony forming units of clindamycin resistant p. acne.

Outcome measures

Measure	Duac n=27 Participants Clindamycin and benzoyl peroxide topical gel	Ziana n=27 Participants Clindamycin and topical tretinoin gel
Median Change in Clindamycin Resistant P. Acne. Change from Baseline to Week 2	-0.30 Clindamycin- resistant P. acne counts Interval -1.74 to 0.0	0 Clindamycin- resistant P. acne counts Interval 0.0 to 0.4
Median Change in Clindamycin Resistant P. Acne. Change from Baseline to Week 4	0 Clindamycin- resistant P. acne counts Interval -1.43 to 0.0	0 Clindamycin- resistant P. acne counts Interval -0.51 to 0.12
Median Change in Clindamycin Resistant P. Acne. Change from Baseline to Week 8	-0.86 Clindamycin- resistant P. acne counts Interval -1.95 to 0.0	0 Clindamycin- resistant P. acne counts Interval -0.1 to 0.6
Median Change in Clindamycin Resistant P. Acne. Change from Baseline to Week 12	-0.83 Clindamycin- resistant P. acne counts Interval -1.53 to 0.0	0.39 Clindamycin- resistant P. acne counts Interval 0.0 to 0.88
Median Change in Clindamycin Resistant P. Acne. Change from Baseline to Week 16	-0.30 Clindamycin- resistant P. acne counts Interval -1.84 to 0.0	0 Clindamycin- resistant P. acne counts Interval -0.03 to 0.25

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, and 16

Population: ITT

Total colony forming units of erythromycin-resistant p. acnes.

Outcome measures

Measure	Duac n=27 Participants Clindamycin and benzoyl peroxide topical gel	Ziana n=27 Participants Clindamycin and topical tretinoin gel
Median Change in Erythromycin-resistant P. Acne Counts Change from Baseline to Week 2	-0.36 Erythromycin-resistant P. acne counts Interval -1.67 to 0.0	0 Erythromycin-resistant P. acne counts Interval 0.0 to 0.56
Median Change in Erythromycin-resistant P. Acne Counts Change from Baseline to Week 4	-0.18 Erythromycin-resistant P. acne counts Interval -1.51 to 0.0	0 Erythromycin-resistant P. acne counts Interval 0.0 to 0.68
Median Change in Erythromycin-resistant P. Acne Counts Change from Baseline to Week 8	-0.83 Erythromycin-resistant P. acne counts Interval -2.26 to 0.0	0 Erythromycin-resistant P. acne counts Interval 0.0 to 0.4
Median Change in Erythromycin-resistant P. Acne Counts Change from Baseline to Week 12	-.91 Erythromycin-resistant P. acne counts Interval -1.68 to 0.0	0.15 Erythromycin-resistant P. acne counts Interval 0.0 to 0.88
Median Change in Erythromycin-resistant P. Acne Counts Change from Baseline to Week 16	0 Erythromycin-resistant P. acne counts Interval -1.81 to 0.0	0.04 Erythromycin-resistant P. acne counts Interval 0.0 to 0.48

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, and 16

Population: ITT

Median Change in Total Acne Lesions

Outcome measures

Measure	Duac n=27 Participants Clindamycin and benzoyl peroxide topical gel	Ziana n=27 Participants Clindamycin and topical tretinoin gel
Median Change in Total Acne Lesions Change from Baseline to Week 2	-14 Total Acne Lesion Counts Interval -22.0 to -4.0	-13 Total Acne Lesion Counts Interval -23.0 to 2.0
Median Change in Total Acne Lesions Change from Baseline to Week 4	-22 Total Acne Lesion Counts Interval -30.0 to -16.0	-14 Total Acne Lesion Counts Interval -24.0 to -2.0
Median Change in Total Acne Lesions Change from Baseline to Week 8	-27 Total Acne Lesion Counts Interval -38.0 to -9.0	-19 Total Acne Lesion Counts Interval -36.0 to -5.0
Median Change in Total Acne Lesions Change from Baseline to Week 12	-26.5 Total Acne Lesion Counts Interval -36.0 to -15.0	-23.5 Total Acne Lesion Counts Interval -34.0 to -11.0
Median Change in Total Acne Lesions Change from Baseline to Week 16	-33 Total Acne Lesion Counts Interval -35.0 to -22.0	-30 Total Acne Lesion Counts Interval -41.5 to -17.0

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, and 16

Population: ITT

Median Change in Inflammatory Acne Lesion Counts

Outcome measures

Measure	Duac n=27 Participants Clindamycin and benzoyl peroxide topical gel	Ziana n=27 Participants Clindamycin and topical tretinoin gel
Median Change in Inflammatory Acne Lesion Counts Change from Baseline to Week 2	-7 Lesion Counts Interval -13.0 to -1.0	-7 Lesion Counts Interval -15.0 to -4.0
Median Change in Inflammatory Acne Lesion Counts Change from Baseline to Week 4	-12 Lesion Counts Interval -18.0 to -3.0	-7 Lesion Counts Interval -15.0 to -1.0
Median Change in Inflammatory Acne Lesion Counts Change from Baseline to Week 8	-11 Lesion Counts Interval -22.0 to -6.0	-7 Lesion Counts Interval -16.0 to -2.0
Median Change in Inflammatory Acne Lesion Counts Change from Baseline to Week 12	-12.5 Lesion Counts Interval -19.0 to -7.0	-10.5 Lesion Counts Interval -17.0 to -5.0
Median Change in Inflammatory Acne Lesion Counts Change from Baseline to Week 16	-14 Lesion Counts Interval -20.0 to -6.0	-14 Lesion Counts Interval -19.0 to -8.0

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, and 16

Median Change in Noninflammaotry Acne Counts

Outcome measures

Measure	Duac n=27 Participants Clindamycin and benzoyl peroxide topical gel	Ziana n=27 Participants Clindamycin and topical tretinoin gel
Median Change in Noninflammaotry Acne Counts Change from Baseline to Week 2	-6 Noninflammatory lesion counts Interval -10.0 to 1.0	-6 Noninflammatory lesion counts Interval -9.0 to 2.0
Median Change in Noninflammaotry Acne Counts Change from Baseline to Week 4	-10 Noninflammatory lesion counts Interval -23.0 to -3.0	-8 Noninflammatory lesion counts Interval -18.0 to 1.0
Median Change in Noninflammaotry Acne Counts Change from Baseline to Week 8	-13 Noninflammatory lesion counts Interval -17.0 to -5.0	-12 Noninflammatory lesion counts Interval -22.0 to 2.0
Median Change in Noninflammaotry Acne Counts Change from Baseline to Week 12	-9 Noninflammatory lesion counts Interval -25.0 to -4.0	-13.5 Noninflammatory lesion counts Interval -18.0 to -2.0
Median Change in Noninflammaotry Acne Counts Change from Baseline to Week 16	-11 Noninflammatory lesion counts Interval -20.0 to -3.0	-16.5 Noninflammatory lesion counts Interval -23.0 to -7.5

Adverse Events

Duac

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Ziana

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Duac n=27 participants at risk Clindamycin and benzoyl peroxide topical gel	Ziana n=27 participants at risk Clindamycin and topical tretinoin gel
Nervous system disorders Attention Deficit Disorder	3.7% 1/27 • Number of events 1 • 16 weeks	0.00% 0/27 • 16 weeks
Infections and infestations Sinus Infection	3.7% 1/27 • Number of events 1 • 16 weeks	3.7% 1/27 • Number of events 1 • 16 weeks
Infections and infestations Gonorrhea	3.7% 1/27 • Number of events 1 • 16 weeks	0.00% 0/27 • 16 weeks
Infections and infestations Head Cold	7.4% 2/27 • Number of events 3 • 16 weeks	3.7% 1/27 • Number of events 1 • 16 weeks
Infections and infestations Oral Thrush	3.7% 1/27 • Number of events 1 • 16 weeks	0.00% 0/27 • 16 weeks
Skin and subcutaneous tissue disorders Oily skin on face	0.00% 0/27 • 16 weeks	3.7% 1/27 • Number of events 1 • 16 weeks
Skin and subcutaneous tissue disorders Skin surgery	0.00% 0/27 • 16 weeks	7.4% 2/27 • Number of events 2 • 16 weeks

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60