Laser and Microdermabrasion Before Photodynamic Therapy for Actinic Keratoses in Field-cancerized Skin
Condition: Actinic Keratosis; Sun Damaged Skin; Solar Keratosis; Solar Skin Damage
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: Ablative Fractional Carbon Dioxide (CO2) Laser; Microdermabrasion
Intervention description: One 50 cm2 test area was randomized to pretreatment using a fractional 2940 nm Er:YAG laser (Joule®; Sciton Inc., Palo Alto, CA, USA). To remove hyperkeratosis, a fully-ablative 4 mm handpiece was optionally applied, followed by a single pass of a fractional Profrax 430 handpiece for all AKs. Subsequent field treatment consisted of a single pass of the Profrax 430 handpiece over the entire test area. Immediately after pretreatment, a 0.5 mm layer of methyl aminolevulinate (Metvix ® cream 16%; Galderma, Paris, France) was applied. After 30 minutes, patients were exposed to 2 hours of ambient daylight, according to approved procedure. After light exposure, cream was wiped off and test areas were covered for the remainder of the day.; Another adjacent 50 cm2 test area was exposed to microdermabrasion using an MD pad with 58.5 µm-diameter particles (Ambu® Skin Prep Pads 2121M; Ambu A/S, Ballerup, Denmark). Lesion-directed treatment consisted of an increasing number of swipes concentrated to AK lesions. During field treatment, multiple swipes were applied in perpendicular directions over the entire test area. Immediately after pretreatment, a 0.5 mm layer of methyl aminolevulinate (Metvix ® cream 16%; Galderma, Paris, France) was applied. After 30 minutes, patients were exposed to 2 hours of ambient daylight, according to approved procedure. After light exposure, cream was wiped off and test areas were covered for the remainder of the day.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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
    

Eligibility criteria:

        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.