A Study to Evaluate the Skin Irritation Potential of PBI-100 Topical Cream in Healthy Participants

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A 21 Day, Randomized, Controlled Study to Evaluate the Skin Irritation Potential of PBI-100 Topical Cream in Healthy Participants Using a Cumulative Irritant Patch Test Design

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: PBI-100 Topical Cream
* Drug: Positive Control - Sodium laurel sulfate (SLS)
* Other: PBI-100 Topical Cream, Vehicle
* Other: Negative Control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Other
Intervention Model: Single Group Assignment
Interventional Model Description: The order of test product patch placement is randomized.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cumulative Irritation Test<br>Participants will receive topical applications of three concentrations of PBI-100 Topical Cream, one application of vehicle, one application of sodium lauryl sulfate as a positive control and one application of a plain patch as a negative control daily (excluding weekends) for 21 days or 15 applications. | Drug: PBI-100 Topical Cream<br>* 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.<br>Drug: Positive Control - Sodium laurel sulfate (SLS)<br>* Approximately 0.4 mL of 0.25% SLS was applied daily (excluding weekends) as a positive control test site.<br>* Other names: SLS;Other: PBI-100 Topical Cream, Vehicle<br>* Approximately 0.4 mL of 0% placebo cream was applied daily (excluding weekends) as a positive control test site.<br>Other: Negative Control<br>* A blank patch was applied daily (excluding weekends) as a negative control test site.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Irritation Potential | Irritation potential based on the Cumulative Irritation Index (CII) | 21 days |