A Study to Evaluate the Skin Irritation Potential of PBI-100 Topical Cream in Healthy Participants (NCT04882631) | Clinical Trial Compass
CompletedPhase 1
A Study to Evaluate the Skin Irritation Potential of PBI-100 Topical Cream in Healthy Participants
United States30 participantsStarted 2021-04-12
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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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 enroll…