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

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

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.

Study Overview

• Status: Completed
• Conditions: Actinic Keratoses
• Intervention / Treatment: Drug: PD P 506 A

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Bonn, Germany, 53111
    • Dermatologisches Zentrum Bonn Friedensplatz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PD P 506 A-PDT; The study medication will be applied to each study lesion for 4 hours. After removal of the study medication the study lesions will be illuminated with red light of defined wavelength (PDT). Second PDT of the lesions will be performed 6-14 days after the first PDT.	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; Other Names: Alacare®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: photonamic GmbH & Co. KG
• Investigators: Principal Investigator: Uwe Reinhold, Professor, dermatologisches zentrum Bonn

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 12, 2018
• Primary Completion (ACTUAL): July 16, 2019
• Study Completion (ACTUAL): July 16, 2019

Study Registration Dates

• First Submitted: July 11, 2018
• First Submitted That Met QC Criteria: July 27, 2018
• First Posted (ACTUAL): July 30, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 27, 2019
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Actinic keratosis on the upper extremities
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Precancerous Conditions; Keratosis, Actinic; Keratosis
• Other Study ID Numbers: AK 13

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No