NCT04882631

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Pyramid Biosciences · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	PBI-100 Topical Cream	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.
DRUG	Positive Control - Sodium laurel sulfate (SLS)	Approximately 0.4 mL of 0.25% SLS was applied daily (excluding weekends) as a positive control test site.
OTHER	PBI-100 Topical Cream, Vehicle	Approximately 0.4 mL of 0% placebo cream was applied daily (excluding weekends) as a positive control test site.
OTHER	Negative Control	A blank patch was applied daily (excluding weekends) as a negative control test site.

Timeline

• Start date: 2021-04-12
• Primary completion: 2021-05-03
• Completion: 2021-05-03
• First posted: 2021-05-12
• Last updated: 2022-01-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study