Clinical trial NCT03006185: Laser and Microdermabrasion Before Photodynamic Therapy for Actinic Keratoses in Field-cancerized Skin
Official title: Pretreatment With Ablative Fractional Laser and Microdermabrasion Before Photodynamic Therapy for Actinic Keratoses in Field-cancerized Skin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Actinic Keratosis
Sun Damaged Skin
Solar Keratosis
Solar Skin Damage
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: Galderma R&D
First posted: 2016-12-30
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

Detailed 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.

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.

Primary outcomes:
measure: Complete Clearance (%) of Actinic Keratoses (AKs)
timeFrame: 12-15 weeks post-treatment
Secondary outcomes:
measure: New Actinic Keratoses (AKs)
timeFrame: 12-15 weeks post-treatment
measure: Severity of Local Skin Reactions (LSRs)
timeFrame: Day 3-6 post treatment
measure: Degree of Sun Damage
timeFrame: 12-15 weeks post-treatment
measure: Treatment-related Pain
timeFrame: during treatment (day 0)
measure: Treatment-related Side Effects
timeFrame: up to 12-15 weeks post-treatment
measure: Investigator-reported Cosmesis (Clinical Evaluation)
timeFrame: 12-15 weeks post-treatment
measure: Patient-reported Cosmesis
timeFrame: 12-15 weeks post-treatment
measure: Patient Pretreatment Preference
timeFrame: 12-15 weeks post-treatment
Other outcomes:
Locations:
Study officials:
affiliation: Bispebjerg Hospital
name: Merete Haedersdal, MD, Dr. Med
role: PRINCIPAL_INVESTIGATOR
References: