- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04035161
Evaluation of the Antimicrobial Effectiveness of CHG/IPA
July 23, 2021 updated by: Becton, Dickinson and Company
Evaluation of the Antimicrobial Effectiveness of CHG/IPA in Healthy Volunteers
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
1935
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Bucharest, Romania, 040256
- Eurofins Evic Product Testing Romania S.R.L.
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Investigational Product
Skin will be prepared with investigational product
|
2%(w/v) Chlorhexidine in 70%(v/v) Isopropyl skin preparation
|
Other: Reference Standard
Skin will be prepared with reference standard
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60% (v/v) 1-propanol skin preparation
|
Active Comparator: Active Control
Skin will be prepared with active comparator
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ChloraPrep® SEPP® skin preparation
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Other: Negative Control
Skin will be prepared with negative control
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0.9% Normal Saline skin preparation
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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
Time Frame: 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
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Antimicrobial Activity (Efficacy): log10 CFU/cm2 of Resident Microbes on Skin at Baseline and 10 Minutes Post-product Application.
Time Frame: 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.
Time Frame: 6 hours post-product application
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Number of participants with bacterial reduction greater than or equal to baseline (0).
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6 hours post-product application
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Responder Rate at 6 Hours Post-Product Application on the Groin.
Time Frame: 6 hours post-product application
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Number of participants with bacterial reduction greater than or equal to baseline (0).
|
6 hours post-product application
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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.
Time Frame: 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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 17, 2019
Primary Completion (Actual)
December 24, 2019
Study Completion (Actual)
December 24, 2019
Study Registration Dates
First Submitted
July 10, 2019
First Submitted That Met QC Criteria
July 26, 2019
First Posted (Actual)
July 29, 2019
Study Record Updates
Last Update Posted (Actual)
August 17, 2021
Last Update Submitted That Met QC Criteria
July 23, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MPS-17IPVSS02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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