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Photodynamic Therapy With PD P 506 A Compared With Placebo-PDT for the Treatment of AK

Sponsor
photonamic GmbH & Co. KG (Industry)
Overall Status
Completed
CT.gov ID
NCT00308854
Collaborator
(none)
107
Enrollment
7
Locations
2
Arms
21
Duration (Months)
15.3
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to investigate whether PD P 506 A-PDT is effective in treating mild to moderate AK lesions located on the head.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Photodynamic Therapy
 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). A direct comparison versus placebo which is necessary for the exact quantification of the effect of PD P 506 A has not yet been performed and is subject of this study protocol.

Study Design

Study Type:
Interventional
Actual Enrollment :
107 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
PD P 506 A or Its Placebo in Combination With Red Light for Photodynamic Therapy of Mild to Moderate Actinic Keratosis
Study Start Date :
Mar 1, 2006
Actual Primary Completion Date :
Aug 1, 2007
Actual Study Completion Date :
Dec 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 1

PD P 506 A-PDT

Procedure: Photodynamic Therapy
Placebo Comparator: 2

Placebo-PDT

Procedure: Photodynamic Therapy

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

  4. Satisfaction and independent cosmetic rating of the cleared study lesions by patient and investigator in case of successful clearance and 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

  • Caucasian patients

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

  • Selected AK study lesions have clearly defined margins and are mild to moderate

  • 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 PDT

  • 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

  • Patients with clinically relevant suppression of the immune system

  • Diagnosis of Porphyria

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Praxis Dr. Popp Dipl.-Med. Weber Augsburg Germany 86179
2 Dermatologisches Zentrum Berlin Berlin Germany 14129
3 Praxisklinik Professor Dr. Uwe Reinhold Bonn Germany 53225
4 Zentrum Dermatologie und Venerologie, Klinikum und Fachbereich Medizin Frankfurt a.M. Germany 60590
5 SciDerm Hamburg Germany 20354
6 Dermatologisches Ambulatorium Hamburg-Alstertal Hamburg Germany 22391
7 Gemeinschaftspraxis Dres. Scholz/Sebastian/Schilling Mahlow Germany 15831

Sponsors and Collaborators

  • photonamic GmbH & Co. KG

Investigators

  • Principal Investigator: Axel Hauschild, Professor MD, Christian-Albrechts-Universität zu Kiel, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00308854
Other Study ID Numbers:
  • AK 03
  • EudraCT Number 2005-003555-13
First Posted:
Mar 30, 2006
Last Update Posted:
Apr 11, 2008
Last Verified:
Apr 1, 2008
Keywords provided by , ,
AK
PDT
Additional relevant MeSH terms:
Keratosis, Actinic
Keratosis

Study Results

No Results Posted as of Apr 11, 2008