Clinical Application of SDL-PDT
- Conditions
- L57.0Actinic keratosis
- Registration Number
- DRKS00020427
- Lead Sponsor
- MVZ Dermatologisches Zentrum Bonn GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
1. Written Informed Consent
2. Men and women, at least 18 years of age
3. Diagnosis actinic keratosis with at least 3 clearly recognizable, separate AK lesions in the face or on the scalp
4. Patient is in the judgement of the Investigator suitable for Ameluz SDL-PDT
Exclusion Criteria
1. Patient is not able to give informed consent
2. AK study lesions are being treated with drugs at study inclusion
3. Intolerability against one or several ingredients of Ameluz 78 mg/g gel
4. Contraindications and/or warning signals to treatemnt with Ameluz 78 mg/g gel are applicable.
5. Expected non-compliance of the patient
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of the effect of a treatment with SDL-PDT and Ameluz two times in comparison to the baseline in the test region based on count of the AK lesions (before-after comparison)
- Secondary Outcome Measures
Name Time Method Evaluation of pain of the subject during and directly after the Ameluz SDL-PDT