This is an open-label, single-arm, randomized, evaluator-blinded repeat insult patch testing (RIPT) study wherein test product is applied under an occlusive dressing to the upper back or arm continuously and repeatedly to the same site for a period of 21 days.

This is an open-label, single-arm, randomized, evaluator-blinded repeat insult patch testing (RIPT) study wherein test product is applied under an occlusive dressing to the upper back or arm continuously and repeatedly to the same site for a period of 21 days. Three concentrations of PBI-100 Topical Cream and vehicle (placebo cream) will be applied to the skin of each subject. In addition, one site will be treated with a positive control and another site will be treated with a plain cotton cloth patch and will serve as a negative control.

Inclusion Criteria:

• Healthy adult male and female volunteers between the ages of 18 and 70 years with Fitzpatrick types I, II, or III.
• Must be willing to follow the study requirements and voluntarily give their informed consent.
• Subjects must be able to read and follow study instructions in English.
• Generally in good health as determined by the investigator, based on medical history interview.
• Evidence of a personally signed and dated Informed Consent indicating that the subject has been informed of and understood all pertinent aspects of the trial.

Exclusion Criteria:

• Scars, moles, or other blemishes over the forearm, upper arm, or back that interfere with the study.
• Sunburn within the last three weeks or use of tanning beds.
• History of allergy or hypersensitivity to skin care or consumer products including fragrances, cosmetics, toiletries, or any kind of tape.
• History of chronic or recurrent dermatological diseases, e.g., psoriasis, atopic eczema, chronic urticaria.
• Subjects receiving systemic or topical drugs which can interfere with the development of an inflammatory response, e.g., steroids, immunosuppressive agents, or retinoids.
• History of any significant systemic diseases e.g., cardiac, pulmonary, renal, hepatic, etc. that would impact subject's ability to complete the study.
• Pregnancy or mothers who are breastfeeding or planning a pregnancy.
• Other conditions considered by the Investigator as sound reasons for disqualification from enrollment into the study.

The participant and evaluator are blinded to the identity of the test product (3 strengths of PBI-100), vehicle, negative control and positive control placed on each subject's forearm, upper arm or back