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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00308854
• Other study ID #: AK 03
• Secondary ID: EudraCT Number 2
• Status: Completed
• Phase: Phase 3
• First received: March 29, 2006
• Last updated: April 10, 2008
• Start date: March 2006
• Est. completion date: December 2007

Study information

• Verified date: April 2008
• Source: photonamic GmbH & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

Procedure:
• Photodynamic Therapy

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
photonamic GmbH & Co. KG

Country where clinical trial is conducted

Germany, 

Outcome

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