Photodynamic Therapy with PD P 506 A or its placebo compared with cryosurgery for the treatment of mild to moderate actinic keratosis
- Conditions
- Actinic Keratosis
- Registration Number
- EUCTR2005-003556-36-DE
- Lead Sponsor
- photonamic GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 315
- Written informed consent has been signed prior to or at Screening Visit
- Caucasian male and female patients
- Age > 18 years
- Diagnosis of actinic keratosis (AK) with at least four locally separated lesions located on the head (hairless areas)
- Selected AK study lesions have clearly defined margins and are mild to moderate (grades I or II):
Mild grade (I): Flat, pink maculae or patch on sun-damaged skin, background mottling, no roughness or hyperkeratosis.
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 study treatment (e.g. antineoplastic topical formulations as e.g. Metvix®, Solaraze®, Aldara®, 5-FU or vitamin A acid containing formulations)
- Pre-treatment of the AK lesions eligible for study procedures during the 2 weeks preceding study treatment with keratolytic agents e.g. TCA, urea or salicylic acid containing formulations
- Pre-treatment with hypericin during the 2 weeks preceding study therapy
- Treatment with systemic retinoids during the 3 months preceding study therapy
- Treatment with cytostatics or radiation during the 3 months preceding study therapy
- 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 treatment
- Skin sun sensitivity type V or VI according to Fitzpatrick
- Known intolerance to one or more of the ingredients of PD P 506 A or PD P 506 P
- Known adverse reactions to cryosurgery (including cold urticaria and cold intolerance)
- 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
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Comparison of the efficacy of <br>- PD P 506 A photodynamic therapy (PD P 506 A-PDT) with placebo-PDT (PD P 506 P-PDT) and<br>- PD P 506 A-PDT with cryosurgery<br>for the treatment of mild to moderate actinic keratoses located on head and face 12 weeks after study therapy on lesion basis<br>;Secondary Objective: - Comparison of the efficacy of the study treatments on patient basis 12 weeks after treatments <br>- Comparison of the efficacy of the study treatments on lesion and patient basis 6, 9 and 12 months after treatment<br>- Comparison of safety and tolerability of the study treatments<br>- Cosmetic outcome 3, 6, 9 and 12 months after study treatments in case of no recurrence of the lesion<br>;Primary end point(s): Complete clinical clearance rate of treated actinic keratosis lesions 12 weeks after study treatment
- Secondary Outcome Measures
Name Time Method