Trial Outcomes & Findings for Anti Propionibacterium(P.) Acnes Activity of Epiduo® Gel Compared to Benzoyl Peroxide (BPO) 2.5% Gel (NCT NCT01188538)

NCT ID: NCT01188538

Last Updated: 2021-02-18

Results Overview

Quantitative bacterial examinations were performed on the subjects' face during the study. These samplings were performed using a method to quantify the follicular microbiological flora of the skin (at Baseline and Week 12 visits).This method consists of a technique allowing the extraction of the outermost layer of epidermis from hair follicle on the cheek and to culture the samplings in order to have the number of P. acnes. Outcome measure = Change from baseline (Log10 cfu/cm²) in count of Follicular P. acnes at end of the study.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 40 participants
• Primary outcome timeframe: Week 12
• Results posted on: 2021-02-18

Participant Flow

40 patients have been enrolled in one site in Poland: First subject included: March 3, 2010; last subject out: August 23, 2010

Participant milestones

Measure	Epiduo Gel	Benzoyl Peroxide (BPO) Gel
Overall Study STARTED	20	20
Overall Study COMPLETED	20	19
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Epiduo Gel	Benzoyl Peroxide (BPO) Gel
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Anti Propionibacterium(P.) Acnes Activity of Epiduo® Gel Compared to Benzoyl Peroxide (BPO) 2.5% Gel

Baseline characteristics by cohort

Measure	Epiduo Gel n=20 Participants	Benzoyl Peroxide (BPO) Gel n=20 Participants	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants	16 Participants n=7 Participants	33 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	22.9 years STANDARD_DEVIATION 4.5 • n=5 Participants	21.4 years STANDARD_DEVIATION 2.9 • n=7 Participants	22.1 years STANDARD_DEVIATION 3.8 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	16 Participants n=7 Participants	34 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment Poland	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 12

Population: Intent To Treat (ITT)/Last Observation Carried Forward (LOCF)

Quantitative bacterial examinations were performed on the subjects' face during the study. These samplings were performed using a method to quantify the follicular microbiological flora of the skin (at Baseline and Week 12 visits).This method consists of a technique allowing the extraction of the outermost layer of epidermis from hair follicle on the cheek and to culture the samplings in order to have the number of P. acnes.

Outcome measure = Change from baseline (Log10 cfu/cm²) in count of Follicular P. acnes at end of the study.

Outcome measures

Measure	Epiduo Gel n=20 Participants	Benzoyl Peroxide (BPO) Gel n=20 Participants
Change From Baseline (Log10 Cfu/cm²) in Count of Follicular P. Acnes	-1.94 Log10 cfu/cm² Standard Deviation 1.69	-1.56 Log10 cfu/cm² Standard Deviation 1.25

SECONDARY outcome

Timeframe: Week 12

Population: ITT (LOCF)

Inflammatory lesions were counted and recorded by the Evaluator (Investigator or designee) at Baseline and at Week 12. Based on these counts at Baseline and Week 12, Percent change (%) from Baseline in inflammatory lesion counts at Week 12 was calculated.

Outcome measures

Measure	Epiduo Gel n=20 Participants	Benzoyl Peroxide (BPO) Gel n=20 Participants
Percent Change (%) in Inflammatory Lesion Counts	-62.8 Percent change (%) Interval -93.3 to 11.1	-68.1 Percent change (%) Interval -100.0 to 11.1

Adverse Events

Epiduo Gel

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Benzoyl Peroxide (BPO) Gel

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Epiduo Gel n=20 participants at risk	Benzoyl Peroxide (BPO) Gel n=20 participants at risk
Infections and infestations Sinusitis	5.0% 1/20 • Number of events 1 • During the study (from baseline to Week 12) Questioning at each follow up visit	0.00% 0/20 • During the study (from baseline to Week 12) Questioning at each follow up visit

Additional Information

Farzaneh SIDOU

Galderma

Phone: 00 33 4 93 95 70 51

Email: farzaneh.sidou@galderma.com

Results disclosure agreements

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

Restriction type: OTHER