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

Pyramid Biosciences

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Other: PBI-100 Topical Cream, Vehicle; Other: Negative Control; Drug: Positive Control - Sodium laurel sulfate (SLS); Drug: PBI-100 Topical Cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT04882631

PBI-100-101

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Cumulative Irritation Test

Experimental group

Description:

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.

Treatment:

Other: PBI-100 Topical Cream, Vehicle

Drug: Positive Control - Sodium laurel sulfate (SLS)

Drug: PBI-100 Topical Cream

Other: Negative Control