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

Primary Purpose

Actinic Keratoses

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
PD P 506 A
Sponsored by
photonamic GmbH & Co. KG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Actinic Keratoses focused on measuring Actinic keratosis on the upper extremities

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dermatologisches Zentrum Bonn Friedensplatz

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PD P 506 A-PDT

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
July 11, 2018
Last Updated
August 27, 2019
Sponsor
photonamic GmbH & Co. KG
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1. Study Identification

Unique Protocol Identification Number
NCT03606122
Brief Title
5-ALA Patch-PDT of Actinic Keratosis on the Upper Extremities
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
July 12, 2018 (Actual)
Primary Completion Date
July 16, 2019 (Actual)
Study Completion Date
July 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
photonamic GmbH & Co. KG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratoses
Keywords
Actinic keratosis on the upper extremities

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PD P 506 A-PDT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
PD P 506 A
Other Intervention Name(s)
Alacare®
Intervention Description
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
Primary Outcome Measure Information:
Title
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.
Description
Percentage of lesions with Clinically Complete Clearance (CCR) 12 weeks after two study treatments.
Time Frame
12 weeks after treatment.
Secondary Outcome Measure Information:
Title
Number and severity of treatment-related adverse events as assessed by NIA Adverse Event and Serious Adverse Event Guidelines.
Description
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.
Time Frame
12 weeks after treatment.
Title
In addition, the percentage of lesions with at least partial clearance 12 weeks after last study treatment will be analysed as a secondary parameter
Description
Percentage of lesions with at least partial clearance 12 weeks after two study treatments.
Time Frame
12 weeks after treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Uwe Reinhold, Professor
Organizational Affiliation
Dermatologisches Zentrum Bonn
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dermatologisches Zentrum Bonn Friedensplatz
City
Bonn
ZIP/Postal Code
53111
Country
Germany

12. IPD Sharing Statement

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

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