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

This study has been completed.
Sponsor:
Information provided by:
photonamic GmbH & Co. KG
ClinicalTrials.gov Identifier:
NCT00308854
First received: March 29, 2006
Last updated: April 10, 2008
Last verified: April 2008
History of Changes
  Purpose

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 Intervention Phase
Actinic Keratosis
 Procedure: Photodynamic Therapy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Further study details as provided by photonamic GmbH & Co. KG:

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

Secondary Outcome Measures:
  • CCR on patient basis 12 weeks, 6, 9 and 12 months after PDT [ Time Frame: 12 months ]
  • CCR of treated actinic keratosis lesions 6, 9 and 12 months after PDT [ Time Frame: 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 ]
  • 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 ]

Enrollment: 107
Study Start Date: March 2006
Study Completion Date: December 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
PD P 506 A-PDT
 Procedure: Photodynamic Therapy
Placebo Comparator: 2
Placebo-PDT
 Procedure: Photodynamic Therapy

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00308854

Locations
Germany
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
SciDerm
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
Investigators
Principal Investigator: Axel Hauschild, Professor MD Christian-Albrechts-Universität zu Kiel, Germany
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00308854     History of Changes
Other Study ID Numbers: AK 03, EudraCT Number 2005-003555-13
Study First Received: March 29, 2006
Last Updated: April 10, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by photonamic GmbH & Co. KG:
AK
PDT

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

ClinicalTrials.gov processed this record on May 21, 2013