Actinic Keratosis
Conditions
Sponsors
photonamic GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Comparison of the efficacy of - PD P 506 A photodynamic therapy (PD P 506 A-PDT) with placebo-PDT (PD P 506 P-PDT) and - PD P 506 A-PDT with cryosurgery for the treatment of mild to moderate actinic keratoses located on head and face 12 weeks after study therapy on lesion basis ;Secondary Objective: - Comparison of the efficacy of the study treatments on patient basis 12 weeks after treatments - Comparison of the efficacy of the study treatments on lesion and patient basis 6, 9 and 12 months after treatment - Comparison of safety and tolerability of the study treatments - Cosmetic outcome 3, 6, 9 and 12 months after study treatments in case of no recurrence of the lesion ;Primary end point(s): Complete clinical clearance rate of treated actinic keratosis lesions 12 weeks after study treatment | — |
Countries
Germany
Outcome results
None listed