Actinic Keratoses
Conditions
Keywords
Actinic keratosis on the upper extremities
Brief summary
This study evaluates the potential usefulness of photodynamic therapy with PD P 506 A in patients with actinic keratosis on the upper extremities for the first time.
Detailed description
Patients will receive a second PD P 506 A-PDT on all AK lesions 1-2 weeks after the first PDT.
Interventions
DRUGPD P 506 A
PD P 506 A is a dermal patch of 4 cm² in size loaded with 2 mg 5-ALA (as 5-ALA HCl) per cm²
Sponsors
photonamic GmbH & Co. KG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 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
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 (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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary aim of the study is the evaluation of the clinical activity of PD P 506 A-PDT of AK on the upper extremities on lesion basis 12 weeks after treatment. | 12 weeks after treatment. | Percentage of lesions with Clinically Complete Clearance (CCR) 12 weeks after two study treatments. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number and severity of treatment-related adverse events as assessed by NIA Adverse Event and Serious Adverse Event Guidelines. | 12 weeks after treatment. | The secondary aim of the study is the evaluation of safety and tolerability of PD P 506 A-PDT of AK on the upper extremities. |
| In addition, the percentage of lesions with at least partial clearance 12 weeks after last study treatment will be analysed as a secondary parameter | 12 weeks after treatment. | Percentage of lesions with at least partial clearance 12 weeks after two study treatments. |
Countries
Germany
Outcome results
None listed