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A Two-week Crossover Evaluation of Two Hand Antiseptic Products on Skin Condition in Healthy Human Subjects

NCT ID: NCT00731042

Last Updated: 2024-12-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2008-07-31

Brief Summary

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Evaluate the effect of two hand antiseptic products on hand skin conditions of healthy volunteers.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Avagard

3M Avagard Surgical and healthcare Personnel Hand Antiseptic with Moisturizers

Group Type EXPERIMENTAL

Avagard

Intervention Type DRUG

Topical solution, 6 mL, 6 applications/day for 14 days.

Purell

Purell Surgical Scrub with Moisturizers

Group Type ACTIVE_COMPARATOR

Purell Surgical Scrub

Intervention Type DRUG

Topical solution, 4 mL, 6 applications/day for 14 days.

Interventions

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Avagard

Topical solution, 6 mL, 6 applications/day for 14 days.

Intervention Type DRUG

Purell Surgical Scrub

Topical solution, 4 mL, 6 applications/day for 14 days.

Intervention Type DRUG

Other Intervention Names

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Purell Surgical Scrub with Moisturizers

Eligibility Criteria

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Inclusion Criteria

* Female age 25 - 55
* Subject agrees not to use any hand wash products on their hands other than what has been provided in the study.
* Subject agrees not to use any moisturizers or any skin products on their hands during the study
* Subject agrees to use gloves to protect hands from activities such as dish washing
* Subject is willing to sign the Informed Consent and HIPAA
* Subject agrees to comply with the study requirement

Exclusion Criteria

* Subject has a history of psoriasis, active dermatitis, skin reactions, cracked, irritated, broken skin, skin infection on their hands
* Subject has scaly skin on hands based on Visual Scoring Scale at Day 1
* Subject has a sensitivity or history of skin reactions to any study materials (eg, alcohol, chlorhexidine gluconate or zinc pyrithone or latex in the gloves)
* Subject has been using moisturizing products or any products on their arms and hands within 5 days prior to participation in the study
* Subject is pregnant
* Study coordinator believes the subject is unsuitable for inclusion in the study
Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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3M

INDUSTRY

Sponsor Role collaborator

Solventum US LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gary L Grove, PhD

Role: PRINCIPAL_INVESTIGATOR

cyberDERM Clinical Research

Other Identifiers

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I2MS05-010877

Identifier Type: -

Identifier Source: org_study_id