Irritation and Sensitization of Chlorhexidine Gluconate (CHG) Cloth

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

249 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-06-30

Brief Summary

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Evaluating the irritation properties of CHG cloth. Some Subjects will also have the product applied to see if they become sensitized to repeated applications.

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Detailed Description

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For the Irritation Study (30 subjects), patches containing CHG, vehicle, saline, CHG comparator or sodium lauryl sulfate (a product that is expected to produce a slight skin irritation) will be placed on the same spot of your skin every day for 21 days. The skin will be examined every day.

The Sensitization Study (200 total subjects) place patches containing CHG, vehicle, saline, CHG comparator on the skin 3 times a week for 3 weeks. Following a two-week rest period the patches will be reapplied for 48 hours and assessed out to 72 hours thereafter.

Conditions

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Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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2% CHG Cloth

Chlorhexidine Gluconate 2%

Group Type EXPERIMENTAL

2% CHG Cloth solution

Intervention Type DRUG

Investigational CHG

Vehicle Cloth

Excipients on cloth

Group Type PLACEBO_COMPARATOR

Vehicle Cloth

Intervention Type DEVICE

Excipients from CHG cloth only

DynaHex (2% CHG)

Chlorhexidine Gluconate 2% solution

Group Type ACTIVE_COMPARATOR

Active Comparator

Intervention Type DRUG

Active comparator

Saline

0.9% sodium chloride

Group Type SHAM_COMPARATOR

Saline

Intervention Type OTHER

Negative control

Sodium Lauryl Sulfate (SLS)

Sodium lauryl sulfate to produce mild irritation as a positive control

Group Type ACTIVE_COMPARATOR

SLS

Intervention Type OTHER

Provides a slight irritation for a positive control

Interventions

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2% CHG Cloth solution

Investigational CHG

Intervention Type DRUG

Vehicle Cloth

Excipients from CHG cloth only

Intervention Type DEVICE

Active Comparator

Active comparator

Intervention Type DRUG

Saline

Negative control

Intervention Type OTHER

SLS

Provides a slight irritation for a positive control

Intervention Type OTHER

Other Intervention Names

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Chlorhexidine Gluconate Control DynaHex-2 Sodium Lauryl Sulfate

Eligibility Criteria

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Inclusion Criteria

* Free of skin disorders
* Signed consent

Exclusion Criteria

* Allergies to latex
* Topical or systemic steroids, antihistamines, antiinflammatory agents 7 days prior or during testing
* severe illness
* Pregnant (females)

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes