Peplin starts phase 2b actinic keratosis trial

By Elaine Rigoli

Tampa, Fla., Aug. 1 - Peplin, Ltd. said its multi-center, 200-patient phase 2b clinical trial in the United States will evaluate PEP005 topical gel for the treatment of actinic (solar) keratosis (AK).

The company said the trial will seek to establish the safety and efficacy of PEP005 topical gel as a patient-applied, take-home prescription medication and build on the positive results demonstrated in Peplin's earlier AK studies, in larger patient cohorts.

There is one primary and two secondary measures of efficacy:

• Primary: complete AK lesion clearance rate defined as the proportion of patients at the day 57 post-treatment visit with no clinically visible AK lesions in the treatment area;

• Secondary: baseline AK lesion clearance rate defined as the proportion of patients at the day 57 post-treatment visit with 100% reduction in the number of AK lesions identified at baseline in the treatment area;

• Secondary: partial clearance rate defined as the proportion of patients at the day 57 post-treatment visit with a 75% or greater reduction in the number of AK lesions identified at baseline in the treatment area.

Peplin is a pharmaceutical company located in Brisbane, Australia.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.