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

NCT ID: NCT00308854

Last Updated: 2008-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2007-12-31

Brief Summary

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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

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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

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Actinic Keratosis

Keywords

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AK PDT

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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1

PD P 506 A-PDT

Group Type ACTIVE_COMPARATOR

Photodynamic Therapy

Intervention Type PROCEDURE

2

Placebo-PDT

Group Type PLACEBO_COMPARATOR

Photodynamic Therapy

Intervention Type PROCEDURE

Interventions

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Photodynamic Therapy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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photonamic GmbH & Co. KG

INDUSTRY

Sponsor Role lead

Principal Investigators

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Axel Hauschild, Professor MD

Role: PRINCIPAL_INVESTIGATOR

Christian-Albrechts-Universität zu Kiel, Germany

Locations

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Praxis Dr. Popp Dipl.-Med. Weber

Augsburg, , Germany

Site Status

Dermatologisches Zentrum Berlin

Berlin, , Germany

Site Status

Praxisklinik Professor Dr. Uwe Reinhold

Bonn, , Germany

Site Status

Zentrum Dermatologie und Venerologie, Klinikum und Fachbereich Medizin

Frankfurt a.M., , Germany

Site Status

SciDerm

Hamburg, , Germany

Site Status

Dermatologisches Ambulatorium Hamburg-Alstertal

Hamburg, , Germany

Site Status

Gemeinschaftspraxis Dres. Scholz/Sebastian/Schilling

Mahlow, , Germany

Site Status

Countries

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Germany

Other Identifiers

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EudraCT Number 2005-003555-13

Identifier Type: -

Identifier Source: secondary_id

AK 03

Identifier Type: -

Identifier Source: org_study_id