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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
30
A dose of approximately 560 ug (approximately 0.4 mL of each of the three concentrations to 3 different sites) of PBI-100 was applied daily (excluding weekends) to the skin test sites.
Approximately 0.4 mL of 0.25% SLS was applied daily (excluding weekends) as a positive control test site.
Approximately 0.4 mL of 0% placebo cream was applied daily (excluding weekends) as a positive control test site.
KGL Skin Study Center
Newtown Square, Pennsylvania, United States
Irritation Potential
Irritation potential based on the Cumulative Irritation Index (CII)
Time frame: 21 days
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A blank patch was applied daily (excluding weekends) as a negative control test site.