Irritation and Sensitization of Chlorhexidine Gluconate (CHG) Cloth

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

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

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.

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)