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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Actinic Keratosis

Intervention / Treatment
-----------------
* Procedure: Photodynamic Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent Caucasian patients Diagnosis of actinic keratosis (AK) with at least three locally separated lesions located on head and/or face (hairless areas) Selected AK study lesions have clearly defined margins and are mild to moderate The distance between the study lesion borders is > 1.0 cm Maximum diameter of each study lesion is 1.8 cm Skin sun sensitivity type I to IV according to Fitzpatrick Exclusion Criteria: PDT Non-responder Pre-treatment of the AK lesions eligible for study procedures with pharmaceuticals approved for the treatment of AK during the 4 weeks preceding PDT Pre-treatment of the AK lesions eligible for study procedures during the 2 weeks preceding PDT with keratolytic agents e.g. TCA, urea or salicylic acid containing formulations Pre-treatment with hypericin during the 2 weeks preceding PDT Treatment with systemic retinoids during the 3 months preceding PDT Treatment with cytostatics or radiation during the 3 months preceding PDT Female patients of childbearing potential Patients with clinically relevant suppression of the immune system Diagnosis of Porphyria Skin diseases that might interfere with response evaluation of study PDT Skin sun sensitivity type V or VI according to Fitzpatrick Known intolerance to one or more of the ingredients of the study medication Dementia or psychic condition that might interfere with the ability to understand the study and thus give a written informed consent Simultaneous participation in another clinical study or participation in another clinical study in the 30 days directly preceding inclusion Suspected lack of compliance

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>PD P 506 A-PDT | Procedure: Photodynamic Therapy<br> <br> |
| Placebo Comparator: 2<br>Placebo-PDT | Procedure: Photodynamic Therapy<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete clinical clearance rate (CCR) of treated actinic keratosis lesions 12 weeks after PDT |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CCR on patient basis 12 weeks, 6, 9 and 12 months after PDT |  | 12 months | 
| CCR of treated actinic keratosis lesions 6, 9 and 12 months after PDT |  | 12 months | 
| Adverse events/reactions and local reactions during application of the study medication as well as during and after study therapy |  | 12 months | 
| Satisfaction and independent cosmetic rating of the cleared study lesions by patient and investigator in case of successful clearance and no recurrence of the lesion |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AK, PDT