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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00308854
Recruitment Status : Completed
First Posted : March 30, 2006
Last Update Posted : April 11, 2008
Information provided by:
photonamic GmbH & Co. KG

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.

Condition or disease Intervention/treatment Phase
Actinic Keratosis Procedure: Photodynamic Therapy Phase 3

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  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: PD P 506 A or Its Placebo in Combination With Red Light for Photodynamic Therapy of Mild to Moderate Actinic Keratosis
Study Start Date : March 2006
Actual Primary Completion Date : August 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
PD P 506 A-PDT
Procedure: Photodynamic Therapy
Placebo Comparator: 2
Procedure: Photodynamic Therapy

Primary Outcome Measures :
  1. Complete clinical clearance rate (CCR) of treated actinic keratosis lesions 12 weeks after PDT [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. CCR on patient basis 12 weeks, 6, 9 and 12 months after PDT [ Time Frame: 12 months ]
  2. CCR of treated actinic keratosis lesions 6, 9 and 12 months after PDT [ Time Frame: 12 months ]
  3. Adverse events/reactions and local reactions during application of the study medication as well as during and after study therapy [ Time Frame: 12 months ]
  4. 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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00308854

Praxis Dr. Popp Dipl.-Med. Weber
Augsburg, Germany, 86179
Dermatologisches Zentrum Berlin
Berlin, Germany, 14129
Praxisklinik Professor Dr. Uwe Reinhold
Bonn, Germany, 53225
Zentrum Dermatologie und Venerologie, Klinikum und Fachbereich Medizin
Frankfurt a.M., Germany, 60590
Hamburg, Germany, 20354
Dermatologisches Ambulatorium Hamburg-Alstertal
Hamburg, Germany, 22391
Gemeinschaftspraxis Dres. Scholz/Sebastian/Schilling
Mahlow, Germany, 15831
Sponsors and Collaborators
photonamic GmbH & Co. KG
Principal Investigator: Axel Hauschild, Professor MD Christian-Albrechts-Universität zu Kiel, Germany Identifier: NCT00308854     History of Changes
Other Study ID Numbers: AK 03
EudraCT Number 2005-003555-13
First Posted: March 30, 2006    Key Record Dates
Last Update Posted: April 11, 2008
Last Verified: April 2008

Keywords provided by photonamic GmbH & Co. KG:

Additional relevant MeSH terms:
Keratosis, Actinic
Skin Diseases
Precancerous Conditions