NCT00636480

Brief Summary

Determine the antimicrobial properties of a proposed new product and an already approved product and a placebo (no drug). Study will be conducted using methods dictated by the FDA.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2007

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 14, 2008

Completed
Last Updated

November 26, 2025

Status Verified

November 1, 2025

Enrollment Period

5 months

First QC Date

March 11, 2008

Last Update Submit

November 25, 2025

Conditions

Topical Antisepsis

Keywords

AntimicrobialAntisepsis

Outcome Measures

Primary Outcomes (1)

  • 3.0 log10 reduction in CFU/cm2 on inguinal sites, and 2.0 log10 reduction in CFU/cm2 on abdominal sites

    10 minutes and 6 hours after application of test solutions

Study Arms (3)

CHG 2%-26 ml

EXPERIMENTAL

Chlorhexidine gluconate in an aqueous base, 26 ml applicator

Drug: Chlorhexidine gluconate

ChloraPrep 26 ml

ACTIVE COMPARATOR

ChloraPrep One-Step 26 ml Active drug contains chlorhexidine gluconate and alcohol

Drug: ChloraPrep One Step

Sterile Saline

PLACEBO COMPARATOR

Sterile salt water administered topically.

Drug: Sterile saline

Interventions

Chlorhexidine gluconateDRUG

Chlorhexidine gluconate (2% w/v) in an aqueous base, 26 ml applicator. Active drug contains alcohol and the placebo contains no drug. Administered topically.

Also known as: ChloraPrep AQ
CHG 2%-26 ml
ChloraPrep One StepDRUG

Administer topically

Also known as: Chlorhexidine gluconate 2% w/v and 70% v/v isopropyl alcohol
ChloraPrep 26 ml
Sterile salineDRUG

0.9% NaCl solution

Also known as: Physiologic saline (0.9% NaCl)
Sterile Saline

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Free of dermatoses, cuts, lesions, or other skin disorders on or around the test sites; no exposure to topical or systemic antimicrobials, antibiotics, or steroids (other than contraceptives, for the fourteen (14) day pre-test conditioning period and must agree to abstain from these materials until completion of the study

You may not qualify if:

  • Exposure of test sites to antimicrobial agents, medicated soaps, medicated shampoos, or medicated lotions,
  • Use of biocide-treated pools or hot tubs, use of tanning beds, or sunbathing during the fourteen(14) day pre-test conditioning period or during the test period;
  • Exposure of the test sites to strong detergent, solvents, or other irritants during the fourteen (14) day pre-test conditioning period or during the test period;
  • Use of systemic or topical antibiotic medications, steroid medications other than contraceptives, or any other product known to affect the normal microbial flora of the skin during the fourteen ()14) day pre-test conditioning period or during the test period;
  • Know of allergies to vinyl, latex (rubber), alcohols, metals, inks, or tape adhesives, or to common antibacterial agents found in soaps, lotions, or ointments, particularly chlorhexidine gluconate, and/or isopropyl alcohol;
  • A medical diagnosis of a physical condition, such as a current or recent severe illness, asthma, diabetes, hepatitis, an organ transplant, any immunocompromised conditions such as AIDS (or HIV positive), mitral valve prolapse, or a requirement to take antibiotics prior to dental procedures;
  • Pregnancy, plans to become pregnant within the pre-test and test periods of the study, or nursing a child;
  • Any active skin rashes or breaks in the skin of the test sites;
  • A currently active skin disease or inflammatory skin condition, including contact dermatitis; showering or bathing within the seventy-two (72) hour period prior to sampling; participation in another clinical study in the past thirty (30) days or current participation in another clinical study;
  • Any medical condition or use of any medications, that, in the opinion of the Study Director, should preclude participation;
  • Unwillingness to fulfill the performance requirements of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BioScience Laboratories

Bozeman, Montana, 59715, United States

Location

MeSH Terms

Interventions

chlorhexidine gluconateEthanol

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Daryl S Paulsen, PhD

    President and CEO

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2008

First Posted

March 14, 2008

Study Start

October 1, 2007

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

November 26, 2025

Record last verified: 2025-11

Locations

US(1)