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

January 24, 2012 updated by: 3M
Evaluate the effect of two hand antiseptic products on hand skin conditions of healthy volunteers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 4

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

25 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

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

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Avagard
3M Avagard Surgical and healthcare Personnel Hand Antiseptic with Moisturizers
Drug: Avagard
Topical solution, 6 mL, 6 applications/day for 14 days.
Active Comparator: Purell
Purell Surgical Scrub with Moisturizers
Drug: Purell Surgical Scrub
Topical solution, 4 mL, 6 applications/day for 14 days.
Other Names:
  • Purell Surgical Scrub with Moisturizers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Skin Health, Visual Skin Score (VSS) at 14 Days
Time Frame: Baseline and 14 days
Observe VSS score at 14 days, and graded change of skin health from baseline using scale of 0 (normal) - 5 (very scaly).
Baseline and 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

3M

Investigators

  • Principal Investigator: Gary L Grove, PhD, cyberDERM Clinical Research

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

March 1, 2008

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

August 6, 2008

First Submitted That Met QC Criteria

August 7, 2008

First Posted (Estimate)

August 8, 2008

Study Record Updates

Last Update Posted (Estimate)

January 26, 2012

Last Update Submitted That Met QC Criteria

January 24, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I2MS05-010877

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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