Skip to main content
OpenTrials
Completed

NCT Number: NCT03006185

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Actinic Keratosis Keratosis Keratosis, Actinic Neoplasms Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases Solar Keratosis Solar Skin Damage Sun Damaged Skin

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ablative Fractional Carbon Dioxide (CO2) Laser

Device

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.

Microdermabrasion

Device

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.

Primary outcomes

  1. Complete Clearance (%) of Actinic Keratoses (AKs)

    Time frame: 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 outcomes

  1. New Actinic Keratoses (AKs)

    Time frame: 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.

  2. Severity of Local Skin Reactions (LSRs)

    Time frame: 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.

  3. Degree of Sun Damage

    Time frame: 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.

  4. Treatment-related Pain

    Time frame: 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.

  5. Treatment-related Side Effects

    Time frame: 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.

  6. Investigator-reported Cosmesis (Clinical Evaluation)

    Time frame: 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.

  7. Patient-reported Cosmesis

    Time frame: 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

  8. Patient Pretreatment Preference

    Time frame: 12-15 weeks post-treatment

    Patients were asked to report which pretreatment they preferred: Laser, microdermabrasion, or no preference

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Collaborators

  • Galderma R&D

Registry information

Official study title

Pretreatment With Ablative Fractional Laser and Microdermabrasion Before Photodynamic Therapy for Actinic Keratoses in Field-cancerized Skin

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Dec 30, 2016
Registry last updated
Sep 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.