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

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ClinicalTrials.gov Identifier: NCT03606122
Recruitment Status : Recruiting
First Posted : July 30, 2018
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
photonamic GmbH & Co. KG

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.

Condition or disease Intervention/treatment Phase
Actinic Keratoses Drug: PD P 506 A Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 12, 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

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 Name: Alacare®




Primary Outcome Measures :
  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. [ Time Frame: 12 weeks after treatment. ]
    Percentage of lesions with Clinically Complete Clearance (CCR) 12 weeks after two study treatments.


Secondary Outcome Measures :
  1. Number and severity of treatment-related adverse events as assessed by NIA Adverse Event and Serious Adverse Event Guidelines. [ Time Frame: 12 weeks after treatment. ]
    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.

  2. In addition, the percentage of lesions with at least partial clearance 12 weeks after last study treatment will be analysed as a secondary parameter [ Time Frame: 12 weeks after treatment. ]
    Percentage of lesions with at least partial clearance 12 weeks after two study treatments.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03606122


Contacts
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Contact: Andrea Ebeling, Dr. +49(0)41038006 ext 707 a.ebeling@photonamic.de
Contact: Marcus Stocker, Dr. +49(0)41038006 ext 704 m.stocker@photonamic.de

Locations
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Germany
Dermatologisches Zentrum Bonn Friedensplatz Recruiting
Bonn, Germany, 53111
Principal Investigator: Uwe Reinhold, Prof. Dr.         
Sponsors and Collaborators
photonamic GmbH & Co. KG
Investigators
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Principal Investigator: Uwe Reinhold, Professor Dermatologisches Zentrum Bonn

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Responsible Party: photonamic GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT03606122     History of Changes
Other Study ID Numbers: AK 13
First Posted: July 30, 2018    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by photonamic GmbH & Co. KG:
Actinic keratosis on the upper extremities

Additional relevant MeSH terms:
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Keratosis, Actinic
Keratosis
Skin Diseases
Precancerous Conditions
Neoplasms