Skin Safety Study to Evaluate the Sensitizing Potential in Healthy Volunteers

During the Induction Phase of the study, the study drugs and controls will be applied 9 times for 21 days on the infrascapular area of the back under occlusive patch conditions.

Following induction, subjects will have a 10 to 14-day Rest phase, after which they will enter the challenge Phase, which consists of one 48-hour patch application (occlusive) to a naïve site on the opposite side of the back.

Inclusion criteria

• Health male or female subjects are age 18 years or older
• Signed and dated Informed Consent Form obtained prior to any study related activities
• Subjects are free of any systemic or dermatologic disorder
• For female, females of non childbearing potential or who agree to use a highly effective method of birth control during the study and have a negative urine pregnancy test
• Subjects must be able to communicate with the investigator and understand and comply with the requirement of the study and visit schedule

Exclusion criteria

• Have any visible skin disease at the application site which will interfere with the evaluation of the test site reaction
• Have damaged skin in or around the test sites
• Have a history of sensitivity to adhesive tape
• Have a known sensitivity to constituents present in the material being evaluated
• Have a history of, or are currently being treated for skin cancer
• Have used any study drug and/or participate in any clinical study within 60 days prior to randomization
• To engage in any type of strenuous exercise
• Are pregnant, breastfeeding, or of childbearing potential and who wish to become pregnant during the study
• Are deemed to be ineligible by the investigator