Evaluation of the Antimicrobial Effectiveness of an Antimicrobial Cloth

NCT03229759 | Completed Phase 2 Results FDA Drug

• 1 other identifier: MPS-17IPVAW10
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

Healthy volunteers will receive treatment to two body locations with the investigational product and placebo and the antimicrobial effectiveness of each treatment will be measured.

Conditions

Preoperative Skin Preparation

Outcome Measures

Primary Outcomes (1)

• Bacterial Count at 10 Minutes Post Application

  10 minutes after application of test product

Study Arms (3)

Investigational Product

EXPERIMENTAL

Polyester cloth impregnated with investigational product

Drug: Octenidine Dihydrocloride in aqueous solution

Vehicle Control (VC)

PLACEBO COMPARATOR

Polyester cloth impregnated with the vehicle control

Other: Vehicle Control

Saline Control (SC)

PLACEBO COMPARATOR

Saline applied wtih polyester cloth

Other: Saline Control

Interventions

Octenidine Dihydrocloride in aqueous solution DRUG

application of investigational product

Investigational Product

Vehicle Control OTHER

application of vehicle control

Vehicle Control (VC)

Saline Control OTHER

application of placebo

Saline Control (SC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and/or females, at least 18 years or older and of any race.
• Are in good general health.
• Unable to become pregnant, or willing to use an acceptable method of contraception (i.e. oral contraception, intra-uterine device \[IUD\], diaphragm, condom, abstinence, bilateral Tubal ligation, or are in a monogamous relationship with a partner who has had a Vasectomy) to prevent pregnancy for at least 14 days immediately preceding Treatment Day and throughout the duration of the study, if female of child-bearing potential.
• All female subjects must have a negative urine pregnancy test on Treatment Day prior to any applications of the study products.
• Have skin within 6 inches of the test sites that is free of dermatoses, abrasions, cuts, lesions or other skin disorders.
• Cooperative and willing to follow Subject Instructions
• Cooperative and willing to sign Consent Form and HIPAA Authorization Form.
• Able to read, write and follow instructions in English.

You may not qualify if:

• 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) exposure within 14 days prior to Treatment Day and for the remainder of the study. Restrictions include, but are not limited to antimicrobial-containing soaps, antiperspirants/deodorants, shampoos, lotions, perfumes, after shaves, and colognes.
• Swimming in chemically treated pools or bathing in hot tubs, spas and whirlpools within 14 days prior to Treatment Day and for the remainder of the study.
• Use of tanning beds, hot waxes, or depilatories, including shaving (in the applicable test areas) within 14 days prior to Treatment Day and for the remainder of the study.
• Contact with strong detergents, solvents, acids, bases, bug repellant, fabric softener-treated clothing, UV treated clothing or other household chemicals in the applicable test areas within 14 days of the Treatment Day and for the remainder of the study.
• Subjects who have a history of sensitivity to vinyl, natural rubber latex, adhesive skin products (e.g., Band-Aids, medical tapes), polyester, metals, inks, common antibacterial agents found in common personal beauty or personal care soaps, lotions, or ointments
• Subjects who have asthma requiring medication, 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).
• Subjects who have a history of skin allergies.
• Subjects who have a history of skin cancer within 6 inches of the applicable test areas or have received treatment for any type of internal cancer within the 5 years prior to enrollment.
• Any tattoos or scars on the test sites or within 2 inches of the test sites; skin blemishes or warts may be permissible with the specific approval of the Principal 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 test sites.
• A currently active skin disease or inflammatory skin condition (for example contact dermatitis; psoriasis, and eczema) anywhere on the body.
• Subjects who are pregnant, attempting pregnancy, or nursing.
• Subjects who have showered or bathed within at least 72 hours of the Treatment Day (sponge baths may be taken, however, the lower abdomen and upper thigh region must be avoided).
• Subjects who receive an irritation score of 1 (any redness, swelling, rash, or dryness present at any treatment area) for any individual skin condition prior to the Treatment Day baseline sample collection.
• Participation in another clinical trial in the 30 days prior to signing the informed consent for this study, current enrollment in another clinical trial, or have already participated in this study.

Sponsors & Collaborators

• Becton, Dickinson and Company: lead

Study Sites (1)

BioScience Laboratories

Bozeman, Montana, 59718, United States

Location

Results Point of Contact

• Title: Erin Zook
• Organization: Becton Dickinson

erin.zook@bd.com

224-358-5019

Study Officials

• Christopher Beausoleil

  BioScience Laboratories

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2017
• First Posted: July 26, 2017
• Study Start: June 21, 2017
• Primary Completion: August 4, 2017
• Study Completion: August 4, 2017
• Last Updated: April 23, 2021
• Results First Posted: April 23, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)