Daylight-PDT With MAL for AK and Photodamaged Skin
Status:
Completed
Trial end date:
2018-09-09
Target enrollment:
Participant gender:
Summary
This study is a multicenter study investigating the clinical efficacy of repetitive
daylight-PDT with MAL (Methylaminolevulinate) compared to cryosurgery in regard to
prophylaxis and treatment of AKs (actinic keratoses) in the face. Patients will be randomly
allocated to treatment groups. 5 PDT (photodynamic therapy) treatment sessions (visits 1-5)
will be performed within 18 months. In the control group, cryosurgery will be performed at
visit 1, and in case of non-cleared or newly occurred AKs at visits 2-5.
In the PDT group the patients will apply a chemical sunscreen (SPF 50+) to the whole face and
other light-exposed, unprotected areas of the skin. After at least 15 minutes a lesion
preparation of AKs (removal of crusts) will be performed and MAL will be applied in a thin
layer to the whole face. Within 30 min after MAL application patients expose themselves to
daylight for 2 hours. In the control group, cryosurgery will be performed using liquid
nitrogen spray in each AK lesion; this will be done at visit 1 and, if necessary, also at
visits 2-5. At visits 2-6, the efficacy of the treatment will be evaluated by the observer by
documenting all existing and newly appearing AKs in the face.