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

NCT ID: NCT03606122

Last Updated: 2019-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-12
• Study Completion Date: 2019-07-16

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.

Conditions

Actinic Keratoses

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

PD P 506 A

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Alacare®

Eligibility 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 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

photonamic GmbH & Co. KG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Uwe Reinhold, Professor

Role: PRINCIPAL_INVESTIGATOR

Dermatologisches Zentrum Bonn

Locations

Dermatologisches Zentrum Bonn Friedensplatz

Bonn, , Germany

Countries

Germany

Other Identifiers

AK 13

Identifier Type: -

Identifier Source: org_study_id