NCT00308854

Photodynamic Therapy With PD P 506 A Compared With Placebo-PDT for the Treatment of AK

PD P 506 A or Its Placebo in Combination With Red Light for Photodynamic Therapy of Mild to Moderate Actinic Keratosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: photonamic GmbH & Co. KG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to investigate whether PD P 506 A-PDT is effective in treating mild to moderate AK lesions located on the head.

Detailed description

Actinic keratosis (AK) is a pre-cancerous skin abnormality usually caused by sun exposure. Actinic keratoses occur most commonly in fair skin, especially in the elderly. They mainly occur in sun-exposed skin areas like head and hands. It is standard of care to remove AK when diagnosed, which can be achieved by either physical ablation, chemotherapeutic agents or photodynamic therapy (PDT). A direct comparison versus placebo which is necessary for the exact quantification of the effect of PD P 506 A has not yet been performed and is subject of this study protocol.

Conditions

• Actinic Keratosis

Interventions

Type	Name	Description
PROCEDURE	Photodynamic Therapy

Timeline

• Start date: 2006-03-01
• Primary completion: 2007-08-01
• Completion: 2007-12-01
• First posted: 2006-03-30
• Last updated: 2008-04-11

Locations

7 sites across 1 country: Germany