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IN VIVO Hand Wash Evaluation Study

TABLE OF CONTENTS:

Purpose of Study:

The study was performed to determine the effectiveness of Invisicare as a protective barrier in preserving skin health as compared to the effects of repetitive hand washing using a standard hospital antimicrobial soap.

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Testing Laboratory:

BIOSCIENCE LABORATORIES, INC.

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Protocol:

Twenty (20) human test subjects were recruited and divided into two groups. One group was provided Skinvisible's Antimicrobial Hand Sanitizer Lotion with Invisicare to use at the recommended four (4) hour intervals, the other group (control group) was not.

The 2 groups were then required to wash their hands for (thirty) 30 seconds followed by a thirty (30) second rinse, ten times each day for a period of five (5) days. Each member of both groups was brought into the lab twice a day for visual inspection of the hands and measurements using the TC 350 Skin Centre which measures two important quantifiable parameters not readily apparent on visual inspection. These parameters are the trans-epidermal water loss (TEWL) and stratum corneum moisture content.

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Results:

Subjects Not Using the Hand Sanitzer Lotion with Invisicare:
  • Forty percent (40%) of the participants in the control group (no Lotion), did not complete the study due to the effects of delipidation by detergents with onset of painful dermatitis.
  • These subjects also had a significant increase in irritation, as assessed visually; compared to those subjects who used Hand Sanitizer Lotion with Invisicare.
  • A significantly lower skin moisture content was noted after six (6) days among the control group as well.
Subjects Using the Hand Sanitzer Lotion with Invisicare:
  • Demonstrated an ability to prevent skin irritation caused by extensive use of a common 4% chlorhexidine gluconate healthcare personnel hand wash product.
  • Trans-epidermal water loss (TEWL) and stratum corneal moisture retention measurements indicated an increase in natural skin barrier protection.
  • The group showed an improvement in epidermal moisture content over pre-study baselines.
  • Adherence characteristics of the lotion with Invisicare, and its proven ability to form a protective barrier on the skin, suggests that it is a solution to the potentially devastating problems caused by frequent hand washing.

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Figure 1:   Graph of the Mean Change from Baseline Scores for Visual
            Evaluations for Both Test Configurations

Note: Mean scores (minus the Day 1, Baseline Sample Value) for the Tewameter and Corneometer are presented in the Figure 1 and Figure 2, respectively. A significant difference was noted between Configuration 1 Corneometer and Configuration 2 Corneometer readings on Day 6 (p < 0.047). The mean baseline-adjusted Corneometer scores are graphically presented in Figure 2.

 

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Figure 2:   Graph of the Mean Baseline-Adjusted Corneometer
            Scores for Both Test Configurations

 

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