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

PHASE1CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

April 12, 2021

Primary Completion Date

May 3, 2021

Study Completion Date

May 3, 2021

Conditions
Healthy Volunteers
Interventions
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.

Trial Locations (1)

19073

KGL Skin Study Center, Newtown Square

Sponsors
All Listed Sponsors
lead

Pyramid Biosciences

INDUSTRY