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
|Condition or disease||Intervention/treatment||Phase|
|Actinic Keratoses||Drug: PD P 506 A||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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®
- 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.
- 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.
- 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.
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
|Contact: Andrea Ebeling, Dr.||+49(0)41038006 ext firstname.lastname@example.org|
|Contact: Marcus Stocker, Dr.||+49(0)41038006 ext email@example.com|
|Dermatologisches Zentrum Bonn Friedensplatz||Recruiting|
|Bonn, Germany, 53111|
|Principal Investigator: Uwe Reinhold, Prof. Dr.|
|Principal Investigator:||Uwe Reinhold, Professor||Dermatologisches Zentrum Bonn|