PD P 506 A applied for 0.5, 1, 2 or 4 hours in combination with red light for photodynamic therapy of mild to moderate actinic keratosis
- Conditions
- Actinic keratosis
- Registration Number
- EUCTR2004-001949-15-DE
- Lead Sponsor
- photonamic GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
- Written informed consent has been signed and dated
- Caucasian male and female patients
- Age > 18 years
- Diagnosis of actinic keratosis (AK) which has been proven histologically in the
patient’s history with at least three locally separated lesions located on the head
(hairless areas) including the face
-Selected AK study lesions are mild to moderate (grade I - II):
Mild grade (I): Flat, pink maculae or patch on sun-damaged skin,
background mottling, no roughness or hyper-keratosis.
Moderate grade (II): Pink to red papule or plaque with rough, hyperkeratotic
surface, variable induration.
- 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- 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 the study (e.g. antineoplastic topical formulations as e.g. Metvix®, Solaraze®, 5-FU or vitamin A acid containing formulations)
- Pre-treatment of the AK lesions eligible for study procedures during the 2 weeks preceding the study with keratolytic agents e.g. urea or salicylic acid containing formulations
- Treatment with systemic retinoids during the 3 months preceding the study
- Use of photosensitising drugs e.g. tetracycline within a time frame where photosensitisation from these drugs may still be present
- Female patients of childbearing potential
- Diagnosis of Porphyria
- Known or suspect acute or chronic hepatic diseases (levels of ASAT, ALAT and/or gamma-GT more than 1.5 times the upper normal limit)
- Manifest renal diseases with renal dysfunction
- Known suppression of the immune system caused either virally or pharmacologically
- Condition after organ transplantation
- Any major concomitant disease
- Psoriasis on the head
- Skin diseases that might interfere with response evaluation of PD P 506 A-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
- Relationship of dependence between patient and sponsor or patient and investigator
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Determination of the optimal application duration (0.5, 1, 2 or 4 h) of PD P 506 A at fixed light dosage (37 J/cm²) and wavelength (630 +/- 3 nm) for the photodynamic therapy of mild to moderate actinic keratoses located on the head (hairless areas) including face.;Secondary Objective: - Assessment of the safety of photodynamic therapy of actinic keratosis with PD P 506 A (PD P 506 A-PDT ).<br>- Assessment of the safety of PD P 506 A application. <br>- Assessment of the efficacy of PD P 506 A-PDT on a lesion basis at week 4 (visit 5).<br>- Assessment of the efficacy of PD P 506 A-PDT on a patient basis at weeks 4 and 8 after therapy.<br>;Primary end point(s): Clinical complete clearance rate of treated actinic keratosis lesions at week 8 after therapy
- Secondary Outcome Measures
Name Time Method