Laser and Microdermabrasion Before Photodynamic Therapy for Actinic Keratoses in Field-cancerized Skin

Bispebjerg Hospital

Status and phase: Completed; Phase 2

Conditions: Solar Skin Damage; Actinic Keratosis; Sun Damaged Skin; Solar Keratosis

Treatments: Device: Microdermabrasion; Device: Ablative Fractional Carbon Dioxide (CO2) Laser

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03006185

H-16023991

2015-002331-18 (EudraCT Number)

Details and patient eligibility

About

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

Full description

For each study participant, two test areas (A and B) are demarcated in the same anatomical region, with each area containing no less than 5 actinic keratoses (AKs). Test areas are randomized to receive skin pretreatment of EITHER ablative fractional laser OR microdermabrasion prior to photodynamic therapy using methyl aminolevulinate.

Efficacy, local skin reactions and safety of both test areas are evaluated over a 12-15 week follow up period.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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18 participants in 1 patient group

Split-Person Design: Ablative Fractional Carbon Dioxide (CO2) Laser vs Microdermabrasion

Experimental group

Description:

WIthin each participant, two 50 cm2 adjacent test areas were randomized to laser or microdermabrasion pretreatment prior to daylight photodynamic therapy.

Treatment:

Device: Microdermabrasion

Device: Ablative Fractional Carbon Dioxide (CO2) Laser