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PD P 506 A-PDT Versus Placebo-PDT and Cryosurgery for the Treatment of AK

Sponsor
photonamic GmbH & Co. KG (Industry)
Overall Status
Completed
CT.gov ID
NCT00308867
Collaborator
(none)
349
Enrollment
26
Locations
20
Duration (Months)
13.4
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to investigate how the efficacy and tolerability of PD P 506 A-PDT relate to the commonly used cryosurgery in the treatment of mild to moderate AK lesions located on the head. To be able to quantify the effect the patient will be allocated to one of three treatments: PD P 506 A-PDT, cryosurgery or placebo-PDT.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Photodynamic Therapy
  • Procedure: Cryosurgery
 Phase 3

Detailed Description

Actinic keratosis (AK) is a pre-cancerous skin abnormality usually caused by sun exposure. Actinic keratoses occur most commonly in fair skin, especially in the elderly. They mainly occur in sun-exposed skin areas like head and hands. It is standard of care to remove AK when diagnosed, which can be achieved by either physical ablation, chemotherapeutic agents or photodynamic therapy (PDT). In Europe, cryosurgery is the method primarily used and will therefore serve as comparator therapy for PD P 506 A-PDT. A placebo control will be necessary to validate the test system. While the comparison of PD P 506 A-PDT and cryosurgery is an open comparison, placebo-PDT and PD P 506 A-PDT will be allocated in a double-blind manner.

Study Design

Study Type:
Interventional
Actual Enrollment :
349 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Photodynamic Therapy With PD P 506 A or Its Placebo Compared With Cryosurgery for the Treatment of Mild to Moderate Actinic Keratosis
Study Start Date :
Mar 1, 2006
Actual Primary Completion Date :
Jun 1, 2007
Actual Study Completion Date :
Nov 1, 2007

Outcome Measures

Primary Outcome Measures

  1. Complete clinical clearance rate (CCR) of treated actinic keratosis lesions 12 weeks after study treatment. [12 weeks]

Secondary Outcome Measures

  1. CCR on patient basis 12 weeks, 6, 9 and 12 months after study treatment [12 months]

  2. CCR of treated actinic keratosis lesions 6, 9 and 12 months after study treatment [12 months]

  3. Adverse events/reactions and local reactions during application of the study medication as well as during and after study therapy (PDT or cryosurgery) [12 months]

  4. Satisfaction and independent cosmetic rating of the cleared study lesions by patient and investigator in case of no recurrence of the lesion [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Written informed consent

  • Caucasians

  • Age > 18 years

  • Diagnosis of actinic keratosis (AK) with at least four locally separated lesions located on head and/or face (hairless areas)

  • Selected AK study lesions have clearly defined margins and are mild to moderate (grades I or II)

  • The distance between the study lesion borders is > 1.0 cm

  • Maximum diameter of each study lesion is 1.8 cm

  • 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 study treatment

  • Pre-treatment of the AK lesions eligible for study procedures during the 2 weeks preceding study treatment with keratolytic agents e.g. TCA, urea or salicylic acid containing formulations

  • Pre-treatment with hypericin during the 2 weeks preceding study therapy

  • Treatment with systemic retinoids during the 3 months preceding study therapy

  • Treatment with cytostatics or radiation during the 3 months preceding study therapy

  • Female patients of childbearing potential

  • Patients with clinically relevant suppression of the immune system

  • Diagnosis of Porphyria

  • Skin diseases that might interfere with response evaluation of study treatment

  • Skin sun sensitivity type V or VI according to Fitzpatrick

  • Known intolerance to one or more of the ingredients of the study medication

  • Known adverse reactions to cryosurgery (including cold urticaria and cold intolerance)

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Gemeinschaftspraxis Dr. Popp, Dipl.-Med. Weber Augsburg Germany 86179
2 Klinik für Dermatologie, Venerologie und Allergologie der Charite, Universitätsmedizin Berlin Berlin Germany 10117
3 Praxis Dr. Simon Berlin Germany 10827
4 Gemeinschaftspraxis Dres. Steinert Biberach Germany 88400
5 Elbekliniken Dermatologisches Zentrum Buxtehude Germany 21614
6 Gemeinschaftspraxis Dr. Dominicus, Dr. Bockhorst Duelmen Germany 48249
7 Zentrum Dermatologie und Venerologie, Klinikum und Fachbereich Medizin Frankfurt a.M. Germany 60590
8 Gemeinschaftspraxis Prof. Melnik, H. Hariry Guetersloh Germany 33330
9 Gemeinschaftspraxis PD Dr. Petering, Dr. Röhrig-Petering Hildesheim Germany 31134
10 Gemeinschaftspraxis Dr. Denzer-Fürst, Dr. Kietzmann Kiel Germany 24103
11 Gemeinschaftspraxis Dr. Schirren, Dr. Lischner, Dr. Podszuweit Kiel Germany 24103
12 Tagesklinik für Allergie- u. Hautkrankheiten Kiel Germany 24148
13 Praxis Dr. Habermann Koblenz Germany 56068
14 Praxis Dr. Fritz Landau Germany 76829
15 Gemeinschaftspraxis PD Dr. Plötz, Prof. Dr. Abeck Muenchen Germany 81545
16 Praxis Dr. Tanner Noerdlingen Germany 86720
17 Praxis Dr. Nickel Pfungstadt Germany 64319
18 Praxis Dr. Itschert Pinneberg Germany 25421
19 Praxis Dr. Rozsondai Radolfzell Germany 78315
20 Praxis Dr. Gehse Rastatt Germany 76437
21 Klinikum der Universität Regensburg, Klinik und Poliklinik für Dermatologie Regensburg Germany 93053
22 Praxis Dr. Karl Soest Germany 59494
23 Praxis Dr. Datz Tuebingen Germany 72072
24 Gemeinschaftspraxis Dr. Borrosch, Dr. Jasnoch Vechta Germany 49377
25 Praxis Dr. Imberger Westerland Germany 25980
26 Praxis PD Dr. Dirschka Wuppertal Germany 42275

Sponsors and Collaborators

  • photonamic GmbH & Co. KG

Investigators

  • Principal Investigator: Rolf-Marcus Szeimies, Professor MD, Klinikum der Universität Regensburg, Kinik und Poliklinik für Dermatologie

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00308867
Other Study ID Numbers:
  • AK 04
  • EudraCT No. 2005-003556-36
First Posted:
Mar 30, 2006
Last Update Posted:
Apr 11, 2008
Last Verified:
Apr 1, 2008
Keywords provided by , ,
PDT
AK
Cryosurgery
Additional relevant MeSH terms:
Keratosis, Actinic
Keratosis

Study Results

No Results Posted as of Apr 11, 2008