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

Phase 2

Completed

• Conditions: Sun Damaged Skin; Solar Keratosis; Actinic Keratosis; Solar Skin Damage
• Interventions: Device: Ablative Fractional Carbon Dioxide (CO2) Laser; Device: Microdermabrasion

• Registration Number: NCT03006185
• Lead Sponsor: Bispebjerg Hospital

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.

Study Timeline

• Study Start: 2016-08
• Primary Completion: 2016-11
• Study First Submitted: 2016-12-09
• Study First Submitted QC: 2016-12-26
• Study First Posted: 2016-12-30
• Study Completion: 2017-03-01
• Results First Submitted: 2018-01-20
• Status Verified: 2022-09
• Results First Submitted QC: 2022-09-13
• Last Update Submitted: 2022-09-13
• Results First Posted: 2022-09-28
• Last Update Posted: 2022-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Split-Person Design: Ablative Fractional Carbon Dioxide (CO2) Laser vs Microdermabrasion	Ablative Fractional Carbon Dioxide (CO2) Laser	WIthin each participant, two 50 cm2 adjacent test areas were randomized to laser or microdermabrasion pretreatment prior to daylight photodynamic therapy.
Split-Person Design: Ablative Fractional Carbon Dioxide (CO2) Laser vs Microdermabrasion	Microdermabrasion	WIthin each participant, two 50 cm2 adjacent test areas were randomized to laser or microdermabrasion pretreatment prior to daylight photodynamic therapy.

Primary Outcome Measures

Name	Time	Method
Complete Clearance (%) of Actinic Keratoses (AKs)	12-15 weeks post-treatment	Percentage clearance of baseline actinic keratoses (AKs), determined by the ratio of AK lesions that are clinically resolved 12-15 weeks after treatment compared to the AK number at baseline.

Secondary Outcome Measures

Name	Time	Method
New Actinic Keratoses (AKs)	12-15 weeks post-treatment	Number of new actinic keratoses (AKs) identified clinically 12-15 weeks after treatment and that were not present at the baseline evaluation.
Treatment-related Pain	during treatment (day 0)	Patient-reported pain during treatments is evaluated using the visual analog scale (VAS) where 0= no pain and 10= worst imaginable pain.
Patient-reported Cosmesis	12-15 weeks post-treatment	Cosmetic appearance is evaluated by patients at the end of the study (scores on a scale) using a 4 point scale where 0 = none, 1= acceptable, 2= good and 3= excellent
Patient Pretreatment Preference	12-15 weeks post-treatment	Patients were asked to report which pretreatment they preferred: Laser, microdermabrasion, or no preference
Treatment-related Side Effects	up to 12-15 weeks post-treatment	Side effects are evaluated over the course 12-15 weeks following treatment. In addition to unforeseen adverse events, specific side effects including the clinical presence of infection, scarring, hypopigmentation and hyperpigmentation are recorded.
Severity of Local Skin Reactions (LSRs)	Day 3-6 post treatment	Local skin reactions scale (min:0; better and max: 3; worse) used to grade each of the following parameters: erythema, edema, crusting, pustules, ulceration and scabbing, scaling.; The severity of each evaluated clinically on a 4-point scale where 0 = none, 1= mild, 2= moderate and 3= severe.; With 7 parameters the sum of all scores will produce a maximum composite score of 21.
Degree of Sun Damage	12-15 weeks post-treatment	Sun damage is evaluated clinically on a 4 point scale where 0 = none, 1= mild, 2= moderate and 3= severe sun damage.
Investigator-reported Cosmesis (Clinical Evaluation)	12-15 weeks post-treatment	Cosmetic appearance of treated areas is evaluated by investigators clinically (scores on a scale) using a 4-point scale where 0 = none, 1= acceptable, 2= good and 3= excellent outcome.