Laser and Microdermabrasion Before Photodynamic Therapy for Actinic Keratoses in Field-cancerized… (NCT03006185) | Clinical Trial Compass
CompletedPhase 2
Laser and Microdermabrasion Before Photodynamic Therapy for Actinic Keratoses in Field-cancerized Skin
18 participantsStarted 2016-08
Plain-language summary
Comparison of treatment efficacy and safety of pretreatment with ablative fractional laser versus microdermabrasion combined with large-area photodynamic therapy with methyl aminolevulinate for actinic keratoses
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with two skin areas of at least 50 cm2 with a minimum of 5 actinic keratoses (AKs) grade I-III, chronically sun damaged "field" changes in one of the following anatomical regions: face, scalp, upper chest.
* Patients who have given written informed consent and are believed to be capable of following the study protocol.
* Fertile women must have a negative pregnancy test (urine-hCG) at the time of inclusion and use anti-contraception (oral contraceptives, intrauterine device, gestagen depot injection, subdermal implantation, vaginal ring, transdermal depot bandage or sterilisation) during the study.
Exclusion Criteria:
* Patients that have within the last month received local treatment in the test areas.
* Pregnant or nursing patients.
* Patients with porphyria
* Patients with skin cancer, keratoacanthoma, or other infiltrating tumors within the test areas.
* Patients with a tendency to develop hypertrophic scars or keloids.
* Patients with a known allergy to Metvix cream
* Patients that are believe unlikely to follow the study protocol.