Actinic Keratosis Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 107 |
Est. completion date | December 2007 |
Est. primary completion date | August 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Praxis Dr. Popp Dipl.-Med. Weber | Augsburg | |
Germany | Dermatologisches Zentrum Berlin | Berlin | |
Germany | Praxisklinik Professor Dr. Uwe Reinhold | Bonn | |
Germany | Zentrum Dermatologie und Venerologie, Klinikum und Fachbereich Medizin | Frankfurt a.M. | |
Germany | Dermatologisches Ambulatorium Hamburg-Alstertal | Hamburg | |
Germany | SciDerm | Hamburg | |
Germany | Gemeinschaftspraxis Dres. Scholz/Sebastian/Schilling | Mahlow |
Lead Sponsor | Collaborator |
---|---|
photonamic GmbH & Co. KG |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complete clinical clearance rate (CCR) of treated actinic keratosis lesions 12 weeks after PDT | 12 weeks | ||
Secondary | CCR on patient basis 12 weeks, 6, 9 and 12 months after PDT | 12 months | ||
Secondary | CCR of treated actinic keratosis lesions 6, 9 and 12 months after PDT | 12 months | ||
Secondary | Adverse events/reactions and local reactions during application of the study medication as well as during and after study therapy | 12 months | ||
Secondary | 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 |
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