NCT01638117

Cumulative Irritation Test of PAC-14028 in Healthy Volunteers

Phase I Clinical Trial to Investigate the Cumulative Skin Irritation of PAC-14028 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Amorepacific Corporation · Industry
• Sex: All
• Age: 20 Years – 59 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the cumulative irritation potential of the products listed by the Sponsor.

Detailed description

Healthy, adult volunteers of either sex will be patched daily on his/her arm with multiple strengths of PAC-14028 cream, non-active comparator and an active comparator over the course of 21 consecutive days. Twenty-four hours after each application, the Finn-chamber patches will be removed and the site evaluated using a five-point scale for irritation.

Conditions

• Healthy

Interventions

Type	Name	Description
OTHER	PAC14028-Vehicle	PAC-14028 Cream Vehicle, Daily for up to 21 days
DRUG	PAC14028-0.1	PAC-14028 Cream, 0.1%, Daily for up to 21 days
DRUG	PAC14028-0.3	PAC-14028 Cream, 0.3%, Daily for up to 21 days
DRUG	PAC14028-1.0	PAC-14028 Cream, 1%, Daily for up to 21 days
OTHER	Saline	Saline, Daily for up to 21 days
OTHER	Positive	Sodium Lauryl Sulfate, 0.5%, Daily for up to 21 days

Timeline

• Start date: 2012-04-01
• Primary completion: 2012-08-01
• First posted: 2012-07-11
• Last updated: 2014-01-22

Locations

1 site across 1 country: South Korea