Mode
Text Size
Log in / Sign up
N/A N=1,121 Randomized Single-blind Prevention

Evaluation of the Antimicrobial Effectiveness of CHG/IPA

Microbial Colonization

Enrolled (actual)
1,121
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: Antimicrobial log10 Reductions From Baseline for Investigational Product and Reference Standard at 30 Seconds and 6 Hours Post-product Application — 2.53; 2.70; 2.68; 2.73 Log10 CFU/cm^2

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Investigational Product (Combination_product); Reference Standard (Other); Active Comparator (Combination_product); Negative Control (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Becton, Dickinson and Company
Primary completion
Dec 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Antimicrobial log10 Reductions From Baseline for Investigational Product and Reference Standard at 30 Seconds and 6 Hours Post-product Application
2.53; 2.70; 2.68; 2.73; 3.69; 4.07
PRIMARY
Antimicrobial Activity (Efficacy): log10 CFU/cm2 of Resident Microbes on Skin at Baseline and 10 Minutes Post-product Application.
3.93; 3.88; 4.00; 1.34; 1.31; 3.19
PRIMARY
Responder Rate at 6 Hours Post-Product Application on the Abdomen.
286; 305; 265
PRIMARY
Responder Rate at 6 Hours Post-Product Application on the Groin.
295; 293; 291
SECONDARY
Antimicrobial Activity (Efficacy): log10 CFU/cm2 of Resident Microbes on Skin at Baseline and 30 Seconds Post-product Application.
3.93; 3.88; 4.00; 1.40; 1.30; 3.43

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.

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.
  • A
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04035161). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search