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

Launched by PYRAMID BIOSCIENCES · May 6, 2021

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• 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.