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

April 10, 2008 updated by: photonamic GmbH & Co. KG

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

107

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Augsburg, Germany, 86179
        • Praxis Dr. Popp Dipl.-Med. Weber
      • Berlin, Germany, 14129
        • Dermatologisches Zentrum Berlin
      • Bonn, Germany, 53225
        • Praxisklinik Professor Dr. Uwe Reinhold
      • Frankfurt a.M., Germany, 60590
        • Zentrum Dermatologie und Venerologie, Klinikum und Fachbereich Medizin
      • Hamburg, Germany, 20354
        • SCIderm
      • Hamburg, Germany, 22391
        • Dermatologisches Ambulatorium Hamburg-Alstertal
      • Mahlow, Germany, 15831
        • Gemeinschaftspraxis Dres. Scholz/Sebastian/Schilling

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
PD P 506 A-PDT
Procedure: Photodynamic Therapy
PLACEBO_COMPARATOR: 2
Placebo-PDT
Procedure: Photodynamic Therapy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
CCR on patient basis 12 weeks, 6, 9 and 12 months after PDT
Time Frame: 12 months
12 months
CCR of treated actinic keratosis lesions 6, 9 and 12 months after PDT
Time Frame: 12 months
12 months
Adverse events/reactions and local reactions during application of the study medication as well as during and after study therapy
Time Frame: 12 months
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
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

photonamic GmbH & Co. KG

Investigators

  • Principal Investigator: Axel Hauschild, Professor MD, Christian-Albrechts-Universität zu Kiel, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (ACTUAL)

August 1, 2007

Study Completion (ACTUAL)

December 1, 2007

Study Registration Dates

First Submitted

March 29, 2006

First Submitted That Met QC Criteria

March 29, 2006

First Posted (ESTIMATE)

March 30, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

April 11, 2008

Last Update Submitted That Met QC Criteria

April 10, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AK 03
  • EudraCT Number 2005-003555-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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