5-ALA Patch-PDT of Actinic Keratosis on the Upper Extremities

Actinic Keratoses Clinical Trial

Official title:

Evaluation of the Suitability of a 5-ALA Patch (PD P 506 A, Alacare®) in the Photodynamic Therapy (PDT) of Actinic Keratosis on the Upper Extremities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03606122
• Other study ID #: AK 13
• Status: Completed
• Phase: Phase 2
• Start date: July 12, 2018
• Est. completion date: July 16, 2019

Study information

• Verified date: December 2018
• Source: photonamic GmbH & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Patients will receive a second PD P 506 A-PDT on all AK lesions 1-2 weeks after the first PDT.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 16, 2019
• Est. primary completion date: July 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Actinic Keratoses
• Keratosis
• Keratosis, Actinic

Intervention

Drug:
• PD 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

Locations

Country	Name	City	State
Germany	Dermatologisches Zentrum Bonn Friedensplatz	Bonn

Sponsors (1)

Lead Sponsor	Collaborator
photonamic GmbH & Co. KG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Percentage of lesions with Clinically Complete Clearance (CCR) 12 weeks after two study treatments.	12 weeks after treatment.
Secondary	Number and severity of treatment-related adverse events as assessed by NIA Adverse Event and Serious Adverse Event Guidelines.	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.	12 weeks after treatment.
Secondary	In addition, the percentage of lesions with at least partial clearance 12 weeks after last study treatment will be analysed as a secondary parameter	Percentage of lesions with at least partial clearance 12 weeks after two study treatments.	12 weeks after treatment.