Irritation and Sensitization of Chlorhexidine Gluconate (CHG) Cloth

Study Overview
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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.

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.

Official Title
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Randomized and Observer-blinded Study to Evaluate the Cumulative Irritation and Contact Sensitizing Potential of One Finished Test Product

Conditions
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Surgery

Intervention / Treatment
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* Drug: 2% CHG Cloth solution
* Device: Vehicle Cloth
* Drug: Active Comparator
* Other: Saline
* Other: SLS


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2% CHG Cloth<br>Chlorhexidine Gluconate 2% | Drug: 2% CHG Cloth solution<br>* Investigational CHG<br>* Other names: Chlorhexidine Gluconate;|
| Placebo Comparator: Vehicle Cloth<br>Excipients on cloth | Device: Vehicle Cloth<br>* Excipients from CHG cloth only<br>* Other names: Control;|
| Active Comparator: DynaHex (2% CHG)<br>Chlorhexidine Gluconate 2% solution | Drug: Active Comparator<br>* Active comparator<br>* Other names: DynaHex-2;|
| Sham Comparator: Saline<br>0.9% sodium chloride | Other: Saline<br>* Negative control<br>|
| Active Comparator: Sodium Lauryl Sulfate (SLS)<br>Sodium lauryl sulfate to produce mild irritation as a positive control | Other: SLS<br>* Provides a slight irritation for a positive control<br>* Other names: Sodium Lauryl Sulfate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grading Scale for Visual Evaluation of Skin Condition | Irritation: 21 days of patching (total). A reviewer will assign a score based on an 8 point categorical scale to the areas treated at each visit. Sensitization: 35 days (21 days of patching followed by 14 days rest and subsequent patch). A reviewer will assign a score based on an 8 point categorical scale to the areas treated at each visit. SLS was not tested. Grade 0 = No irritation Grade 1 = Minimal erythema Grade 2 = Definite erythema Grade 3 = Erythema and papules Grade 4 = Edema Grade 5 = Erythema, edema and papules Grade 6 = Vesicular eruption Grade 7 = Strong reaction spreading | 21 Days for Irritation (N=39). 35 Days for Sensitization (N=249) |