Evaluation of the suitability of a 5-ALA patch (PD P 506 A, Alacare®) in the photodynamic therapy (PDT) of actinic keratosison the upper extremities
- Conditions
- L57.0Actinic keratosis
- Registration Number
- DRKS00015137
- Lead Sponsor
- photonamic GmbH & Co. KG
- Brief Summary
Photodynamic therapy (PDT) with 5-aminolevulinic acid hydrochloride (ALA) is an established method for the management of AK. PD P 506 A (brand name Alacare®) is an approved medicinal product for the treatment of AK located on scalp and face. It is a self-adhesive, light-proof patch loaded with 5-ALA HCl and was developed for easy handling. AK located on arms, hands or trunk do not respond as well to ALA-PDT as AK lesions on the head do. It has been reported that occlusion during ALA incubation can improve clinical outcome after ALA-PDT for AK on hands and arms. We present the results of a first explorative pilot study involving 20 participants with a total of 145 treated (122 evaluable) AK lesions. The trial investigated the conduct of two ALA-PDTs within 1–2 weeks and involved all severity grades of AK. The model-based percentage of complete clearance on lesion-basis was estimated being 78.0% (95%-CI: [64.6%, 87.3%]), and the by-participant calculation (patient-based clearance) led to similar results (78.7% with a 95%-CI of [67.0%, 90.3%]). The treatment was well tolerated. Local reactions during ALA patch incubation were rare whereas nearly all patients showed the expected reactions during or after the illumination, primarily erythema and pain. The study results indicate that two PD P 506 A-PDT sessions 1–2 weeks apart are an efficacious treatment for AK on hands and arms. Especially mild but also moderate lesions responded very well to PDT treatment involving ALA incubation under occlusion.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 22
• 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 three locally separated lesions located on the upper extremities
• Selected AK study lesions have clearly defined margins and are mild to severe (grades I to III):
- Mild grade (I): Slight palpability, better felt than seen
- Moderate grade (II): Moderately thick AK, easily felt
- Severe grade (III): Very thick and/or obvious AK
• Skin sun sensitivity type I to IV according to Fitzpatrick
•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 (e.g. antineoplastic topical formulations as e.g. Metvix®, Ameluz®, Luxerm®, Solaraze®, Aldara®, Picato®, Actikerall®, 5-FU or vitamin A acid containing formulations)
•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 (A female is considered of childbearing potential unless she has had tubal ligation, hysterectomy or has been postmenopausal, i.e. with spontaneous amenorrhea for at least 12 months.)
•Patients with clinically relevant suppression of the immune system
•Diagnosis of Porphyria
•Known photodermatoses of varying pathology and frequency, e.g. metabolic disorders such as aminoaciduria, idiopathic or immunological disorders such as polymorphic light reaction, genetic disorders such as xeroderma pigmentosum, and diseases precipitated or aggravated by exposure to sun light such as lupus erythematosus or pemphigus erythematosus
•Concomitant use of medicinal products with known phototoxic or photoallergic potential such as hypericin, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulphonamides, quinolones and tetracyclines
•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
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of the clinical activity of 5-ALA patch (PD P 506 A) photodynamic therapy of actinic keratosis on the upper extremities on lesion basis 12 weeks after treatment.
- Secondary Outcome Measures
Name Time Method Evaluation of safety and tolerability of 5-ALA patch (PD P 506 A) photodynamic therapy of actinic keratosis on the upper extremities.