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Article: Peplin Finalizes Enrolment in Its Final Phase 3 Clinical Trial for PEP005 Gel in AK.
- Article from:
- Health & Beauty Close-Up
- Article date:
- August 23, 2009
CopyrightCOPYRIGHT 2009 Close-Up Media, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Peplin, Inc. has announced completion of enrolment in its second Phase 3 clinical trial for the use of PEP005 (ingenol mebutate) Gel to treat actinic (solar) keratoses (AK), a common pre-cancerous skin lesion, on non-head treatment areas, which include the trunk and extremities.
This completes enrolment in the final of four pivotal trials planned for the submission of the New Drug Application (NDA) for AK.
In a release, the Company noted:
This second pivotal Phase 3 trial for non-head locations, known as REGION-Ib, enrolled approximately 200 patients. It is designed to replicate the recently completed REGION-I trial and confirm the results of ...