Trial Outcomes & Findings for Single Dose CHG Pharmacokinetic Study (NCT NCT03331263)

Last Updated: 2023-12-15

Results Overview

A total of 12 blood samples were collected (one tube of 6 mL each) at various time points up before and after product application in each study period and analyzed for plasma levels of chlorhexidine. Blood samples were collected at 10, 2 and 0.5 hours prior to each treatment, and 1, 2, 3, 4, 5, 6, 8, and 12 hours following each treatment.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

12 participants

Primary outcome timeframe

Up to 24 hours after product application

Results posted on

2023-12-15

Participant Flow

12 subjects were enrolled to participate in a 3-period, 3-sequence crossover study design

Each of the 12 subjects were scheduled to receive one of each treatment and randomized to what period they would receive each.

Participant milestones

Participant milestones
Measure	Abdominal Application of 2% CHG Chlorhexidine Gluconate: 2% CHG	Groin Application of 2% CHG Chlorhexidine Gluconate: 2% CHG	Control Treatment With no Application No treatment
Period 1 STARTED	4	4	4
Period 1 COMPLETED	4	4	4
Period 1 NOT COMPLETED	0	0	0
Period 2 STARTED	4	3	4
Period 2 COMPLETED	4	3	4
Period 2 NOT COMPLETED	0	0	0
Period 3 STARTED	4	3	3
Period 3 COMPLETED	4	3	3
Period 3 NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Single Dose CHG Pharmacokinetic Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=12 Participants All 12 study participants are included
Age, Customized	27 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants
Body Mass Index (kg/m2)	26 kg/m^2 STANDARD_DEVIATION 3.3 • n=5 Participants
Weight (kg)	75.6 weight in "kg" STANDARD_DEVIATION 14.8 • n=5 Participants
Height (cm)	169.8 cm STANDARD_DEVIATION 8.8 • n=5 Participants

PRIMARY outcome

Timeframe: Up to 24 hours after product application

Population: There was no statistical analysis planned on the PK results of this study. Results were reported as is. Study was completed as a 3-period, 3-sequence crossover therefore not all arms were analyzed with same amount of participants due to drop out.

Outcome measures

Outcome measures
Measure	Abdominal Application of 2% CHG n=12 Participants Chlorhexidine Gluconate: 2% CHG	Groin Application of 2% CHG n=10 Participants Chlorhexidine Gluconate: 2% CHG	Control Treatment With no Application n=11 Participants No treatment
Number of Subjects With Plasma Levels of Chlorexidine Following Systemic Exposure After a Single Topical Application of CHG.	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 24 hours after product application, overall, up to 3 weeks

Population: Study was completed as a 3-period, 3-sequence crossover therefore not all arms were analyzed with same amount of participants due to drop out.

Number of subjects with treatment related adverse events as assessed by System Organ Class (SOC) using the Medical Dictionary for Regulatory Activities (MedDRA).

Outcome measures

Outcome measures
Measure	Abdominal Application of 2% CHG n=12 Participants Chlorhexidine Gluconate: 2% CHG	Groin Application of 2% CHG n=10 Participants Chlorhexidine Gluconate: 2% CHG	Control Treatment With no Application n=11 Participants No treatment
Number of Subjects With of Treatment Emergent Adverse Events.	1 Participants	1 Participants	1 Participants

Adverse Events

Abdominal Application of 2% CHG

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Groin Application of 2% CHG

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Control Treatment With no Application

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Abdominal Application of 2% CHG n=12 participants at risk Chlorhexidine Gluconate: 2% CHG	Groin Application of 2% CHG n=10 participants at risk Chlorhexidine Gluconate: 2% CHG	Control Treatment With no Application n=11 participants at risk No treatment
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/12 • Three weeks	0.00% 0/10 • Three weeks	9.1% 1/11 • Number of events 1 • Three weeks
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/12 • Three weeks	0.00% 0/10 • Three weeks	9.1% 1/11 • Number of events 1 • Three weeks
General disorders Application site pruritus	0.00% 0/12 • Three weeks	10.0% 1/10 • Number of events 1 • Three weeks	0.00% 0/11 • Three weeks
General disorders Application site pain	0.00% 0/12 • Three weeks	10.0% 1/10 • Number of events 1 • Three weeks	0.00% 0/11 • Three weeks
Nervous system disorders Headache	8.3% 1/12 • Number of events 1 • Three weeks	0.00% 0/10 • Three weeks	0.00% 0/11 • Three weeks

Additional Information

Senior Regulatory Affairs Specialist

Medline Industries, Inc.

Phone: 8476433515

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Written consent must be obtained
Publication restrictions are in place

Restriction type: OTHER