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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00308854
Other study ID # AK 03
Secondary ID EudraCT Number 2
Status Completed
Phase Phase 3
First received March 29, 2006
Last updated April 10, 2008
Start date March 2006
Est. completion date December 2007

Study information

Verified date April 2008
Source photonamic GmbH & Co. KG
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 107
Est. completion date December 2007
Est. primary completion date August 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Photodynamic Therapy


Locations

Country Name City State
Germany Praxis Dr. Popp Dipl.-Med. Weber Augsburg
Germany Dermatologisches Zentrum Berlin Berlin
Germany Praxisklinik Professor Dr. Uwe Reinhold Bonn
Germany Zentrum Dermatologie und Venerologie, Klinikum und Fachbereich Medizin Frankfurt a.M.
Germany Dermatologisches Ambulatorium Hamburg-Alstertal Hamburg
Germany SciDerm Hamburg
Germany Gemeinschaftspraxis Dres. Scholz/Sebastian/Schilling Mahlow

Sponsors (1)

Lead Sponsor Collaborator
photonamic GmbH & Co. KG

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Complete clinical clearance rate (CCR) of treated actinic keratosis lesions 12 weeks after PDT 12 weeks
Secondary CCR on patient basis 12 weeks, 6, 9 and 12 months after PDT 12 months
Secondary CCR of treated actinic keratosis lesions 6, 9 and 12 months after PDT 12 months
Secondary Adverse events/reactions and local reactions during application of the study medication as well as during and after study therapy 12 months
Secondary 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
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Completed NCT02878382 - Potential Impact of Patient Vitamin D Status in AK Response to MAL-PDT N/A
Completed NCT02938715 - Pilot Study of the Pragmatic Use of Mobile Phone Based Follow up of Actinic Keratoses Treated With Topical 5-fluorouracil N/A