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

NCT03606122 | Completed Phase 2

• 1 other identifier: AK 13
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Actinic Keratoses

Keywords

Actinic keratosis on the upper extremities

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number and severity of treatment-related adverse events as assessed by NIA Adverse Event and Serious Adverse Event Guidelines.

  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

  12 weeks after treatment.

Study Arms (1)

PD P 506 A-PDT

EXPERIMENTAL

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

Interventions

PD P 506 A 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

Also known as: Alacare®

PD P 506 A-PDT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• photonamic GmbH & Co. KG: lead

Study Sites (1)

Dermatologisches Zentrum Bonn Friedensplatz

Bonn, 53111, Germany

Location

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Uwe Reinhold, Professor

  Dermatologisches Zentrum Bonn

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2018
• First Posted: July 30, 2018
• Study Start: July 12, 2018
• Primary Completion: July 16, 2019
• Study Completion: July 16, 2019
• Last Updated: August 28, 2019

Record last verified: 2018-12

Locations

DE (1)