MedTrace Logo

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

NCT04882631 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-01-27

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Pyramid Biosciences

    lead INDUSTRY

Principal Investigators

  • Chief Medical Officer · Pyramid Biosciences

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-12
Primary Completion
2021-05-03
Completion
2021-05-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04882631 on ClinicalTrials.gov