Evaluation of the Antimicrobial Effectiveness of CHG/IPA

Study Overview
=================
Brief Summary
-----------------
This single site study is a randomized, controlled, partially-blinded design enrolling a minimum of 516 healthy volunteers, where each subject will receive two of the planned study products on the product application sites of the abdomen and/or groin.

Detailed Description
-----------------
To demonstrate the antimicrobial activity of the Investigational Product (IP) by comparing counts of resident skin microbes, obtained after IP application to intact skin of the abdomen and groin, to counts obtained prior to application.

Official Title
-----------------
Evaluation of the Antimicrobial Effectiveness of CHG/IPA in Healthy Volunteers

Conditions
-----------------
Microbial Colonization

Intervention / Treatment
-----------------
* Combination Product: Investigational Product
* Other: Reference Standard
* Combination Product: Active Comparator
* Other: Negative Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Read, understand, and provide signed informed consent. Are healthy subjects in good general health Are 18 years of age or older If females of childbearing potential, are using an acceptable form of birth control for at least 28 days immediately preceding Day 1 and throughout the duration of the study. Acceptable methods are established, effective hormonal contraception (oral/implant/injectable/transdermal/intra-vaginal), intra-uterine device [IUD], diaphragm with spermicide, condom with spermicide, abstinence, bilateral tubal ligation, or are in a monogamous relationship with a partner who has had a vasectomy In the case of females of childbearing potential, have a negative urine pregnancy test (UPT) on Product Application Day prior to any applications of the study products. Are free of any systemic or dermatologic disorder, which, in the opinion of the Investigator, will interfere with the study results or increase the risk of AEs. Have minimal Screening Day bacterial count. Exclusion Criteria: Have had exposure to topical or systemic antimicrobials or any other product known to affect the normal microbial flora of the skin, antibiotics or steroids (other than hormones for contraception or post-menopausal reasons) within the product restriction period and for the remainder of the study. Restrictions include, but are not limited to antimicrobial soaps, antiperspirants/deodorants, shampoos, lotions, perfumes, after shaves, and colognes. Subjects who have a history of skin allergies. Have known allergies or sensitivity to vinyl, latex (rubber), alcohols, metals, inks, common consumer/beauty products, tape adhesives, or to common antibacterial agents found in soaps, lotions, or ointments, particularly chlorhexidine, or any other product components. Swimming in chemically treated pools or bathing in hot tubs, spas and whirlpools within the product restriction period and for the remainder of the study. Use of tanning beds, hot waxes, or depilatories, including shaving (in the applicable product application areas) within the product restriction period and for the remainder of the study. Have had exposure of the product application sites to strong detergents, acids, bases, bug repellant, fabric softener-treated clothing, UV treated clothing, other household chemicals in the applicable product application areas or other irritants during the product restriction period or during the study period. Have a history of skin cancer within 6 inches of applicable product application areas, or are currently being treated for skin cancer or have received treatment for any type of internal cancer within the 5 years prior to enrollment. Subjects who have a history of asthma, diabetes, hepatitis B or C, an organ transplant, mitral valve prolapse with a heart murmur, congenital heart disease, lupus, Crohn's disease, medicated multiple sclerosis, internal prosthesis or any immunocompromised conditions (such as AIDS or HIV positive). A currently active skin disease or inflammatory skin condition (for example contact dermatitis) anywhere on the body. Any tattoos or scars (including stretch marks) on the product application sites or within 2 inches of the product application sites; skin blemishes or warts may be permissible with the specific approval of the Investigator or consulting physician. Dermatoses, cuts, lesions, active skin rashes, scabs, breaks in the skin or other skin disorders within 6 inches on or around the product application sites. Subjects who have showered or bathed within at least 72 hours of the Product Application Day. Sponge baths may be taken, however, the lower abdomen and upper thigh region must be avoided. Subjects who have an irritation score of 1 or greater (any redness, swelling, rash, or dryness present at any product application area) for any individual skin condition prior to the Product Application Day baseline sample collection. Are females who are pregnant, plan to become pregnant during the study, or are breastfeeding a child. Are unable to adhere to or understand the protocol. Have used an investigational drug or participated in an investigational study within 30 days prior to signing the informed consent for this study or are currently participating in a clinical study. Are employed by or are a family member of staff of BD or the study site conducting the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Healthy adult volunteers that meet inclusion/exclusion criteria will be randomized to receive 2 of the 4 products on bilateral site on the abdomen and/or groin.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational Product<br>Skin will be prepared with investigational product | Combination Product: Investigational Product<br>* 2%(w/v) Chlorhexidine in 70%(v/v) Isopropyl skin preparation<br>|
| Other: Reference Standard<br>Skin will be prepared with reference standard | Other: Reference Standard<br>* 60% (v/v) 1-propanol skin preparation<br>|
| Active Comparator: Active Control<br>Skin will be prepared with active comparator | Combination Product: Active Comparator<br>* ChloraPrep® SEPP® skin preparation<br>|
| Other: Negative Control<br>Skin will be prepared with negative control | Other: Negative Control<br>* 0.9% Normal Saline skin preparation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antimicrobial log10 Reductions From Baseline for Investigational Product and Reference Standard at 30 Seconds and 6 Hours Post-product Application | Bacterial log10/cm^2 reductions for abdominal and groin sites post-product application (30 seconds and 6 hours) using the Investigational Product or Reference Standard. | 30 seconds and 6 hours post-product application | 
| Antimicrobial Activity (Efficacy): log10 CFU/cm2 of Resident Microbes on Skin at Baseline and 10 Minutes Post-product Application. | Evaluation of antimicrobial activity will be based on log10 CFU/cm2 of resident microbes on skin before and after each product application on the abdomen and groin. | Baseline and 10 minutes post-product application | 
| Responder Rate at 6 Hours Post-Product Application on the Abdomen. | Number of participants with bacterial reduction greater than or equal to baseline (0). | 6 hours post-product application | 
| Responder Rate at 6 Hours Post-Product Application on the Groin. | Number of participants with bacterial reduction greater than or equal to baseline (0). | 6 hours post-product application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antimicrobial Activity (Efficacy): log10 CFU/cm2 of Resident Microbes on Skin at Baseline and 30 Seconds Post-product Application. | Evaluation of antimicrobial activity will be based on log10 CFU/cm2 of resident microbes on skin before and after each product application on the abdomen and groin. | Baseline and 30 seconds post-product application |