Clinical trial NCT00308854: Photodynamic Therapy With PD P 506 A Compared With Placebo-PDT for the Treatment of AK
Official title: PD P 506 A or Its Placebo in Combination With Red Light for Photodynamic Therapy of Mild to Moderate Actinic Keratosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Actinic Keratosis
Keywords: AK
PDT
Lead sponsor: photonamic GmbH & Co. KG
Sponsor class: INDUSTRY
First posted: 2006-03-30
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Complete clinical clearance rate (CCR) of treated actinic keratosis lesions 12 weeks after PDT
timeFrame: 12 weeks
Secondary outcomes:
measure: CCR on patient basis 12 weeks, 6, 9 and 12 months after PDT
timeFrame: 12 months
measure: CCR of treated actinic keratosis lesions 6, 9 and 12 months after PDT
timeFrame: 12 months
measure: Adverse events/reactions and local reactions during application of the study medication as well as during and after study therapy
timeFrame: 12 months
measure: 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
timeFrame: 12 months
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: Praxis Dr. Popp Dipl.-Med. Weber
city: Berlin
country: Germany
facility: Dermatologisches Zentrum Berlin
city: Bonn
country: Germany
facility: Praxisklinik Professor Dr. Uwe Reinhold
city: Frankfurt a.M.
country: Germany
facility: Zentrum Dermatologie und Venerologie, Klinikum und Fachbereich Medizin
city: Hamburg
country: Germany
facility: SciDerm
city: Hamburg
country: Germany
facility: Dermatologisches Ambulatorium Hamburg-Alstertal
city: Mahlow
country: Germany
facility: Gemeinschaftspraxis Dres. Scholz/Sebastian/Schilling
Study officials:
affiliation: Christian-Albrechts-Universität zu Kiel, Germany
name: Axel Hauschild, Professor MD
role: PRINCIPAL_INVESTIGATOR
References: