L57.0
Conditions
Interventions
Group 1: 12 subjects with SDL-PDT and Ameluz
Sponsors
MVZ Dermatologisches Zentrum Bonn GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Evaluation of pain of the subject during and directly after the Ameluz SDL-PDT | — |
Countries
Germany
Contacts
Public ContactUwe Reinhold
MVZ Dermatologisches Zentrum Bonn GmbH
Outcome results
None listed