Trial Outcomes & Findings for Topical Treatment and Prevalence of P. Acnes (NCT NCT03257202)

Results Overview

Detected presence of growth of Propionibacterium acnes on bacterial culture (bacteria per mL) by treatment arms.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

12 participants

Primary outcome timeframe

21 days

Results posted on

2019-11-13

Participant Flow

All 12 patients received each of the 4 study arms.

Participant milestones

Participant milestones
Measure	All Study Participants All study participants received all 4 treatments: control, Clindamycin alone, Benzyl peroxide alone, Clindamycin and Benzoyl Peroxide
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=12 Participants 1. Negative Control 2. Topical benzoyl peroxide alone using Benzoyl Peroxide 5% Gel 3. Topical clindamycin alone using Clindamycin 1% Gel 4. BenzaClin 5%-1% Topical Gel: Topical clindamycin and benzoyl peroxide together
Age, Categorical <=18 years	0 Participants n=12 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=12 Participants
Age, Categorical >=65 years	0 Participants n=12 Participants
Age, Continuous	29.4 years n=12 Participants
Sex: Female, Male Female	2 Participants n=12 Participants
Sex: Female, Male Male	10 Participants n=12 Participants
Region of Enrollment United States	12 participants n=12 Participants

PRIMARY outcome

Timeframe: 21 days

Detected presence of growth of Propionibacterium acnes on bacterial culture (bacteria per mL) by treatment arms.

Outcome measures

Outcome measures
Measure	Negative Control n=12 Participants The participants did not receive treatment in this quadrant.	Benzoyl Peroxide 5% Topical Gel n=12 Participants This quadrant on the participants' backs were treated with Benzoyl Peroxide 5% topical gel	Clindamycin 1% Topical Gel n=12 Participants This quadrant of the participants' back received Clindamycin 1% topical gel	Clindamycin 1% Plus Benzoyl Peroxide 5% Topical Gel n=12 Participants This quadrant on the study participants' backs were treated with Clindamycin 1% plus Benzoyl Peroxide 5% topical gel
Number of Subjects With Positive Bacterial Growth Culture Per Treatment Arms	10 participants	12 participants	10 participants	10 participants

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Clindamycin Alone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Benzoyl Peroxide Alone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Clindamycin and Benzoyl Peroxide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. George Hatch

Keck Medical Center of USC

Phone: 323-442-5860

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place