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
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Full eligibility criteria for NCT03006185
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
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.
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.
All locations for NCT03006185
View full eligibility
Tris trial is registered with FDA with number: NCT03006185. The sponsor of the trial is Bispebjerg Hospital and it is looking for 18 volunteers for the current phase.
Official trial title: Pretreatment With Ablative Fractional Laser and Microdermabrasion Before Photodynamic Therapy for Actinic Keratoses in Field-cancerized Skin
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