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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT04882631

Run by

Pyramid Biosciences

People needed

30

Starts

2021-04-12

Expected to finish

2021-05-03

Last updated by the study team

2022-01-27

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• KGL Skin Study Center — Newtown Square, Pennsylvania, United States

Full record on ClinicalTrials.gov

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