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

Primary Purpose

Actinic Keratosis, Sun Damaged Skin, Solar Keratosis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Ablative Fractional Carbon Dioxide (CO2) Laser
Microdermabrasion
Sponsored by
Bispebjerg Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Actinic Keratosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

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

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    Complete Clearance (%) of Actinic Keratoses (AKs)
    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

    New Actinic Keratoses (AKs)
    Number of new actinic keratoses (AKs) identified clinically 12-15 weeks after treatment and that were not present at the baseline evaluation.
    Severity of Local Skin Reactions (LSRs)
    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
    Sun damage is evaluated clinically on a 4 point scale where 0 = none, 1= mild, 2= moderate and 3= severe sun damage.
    Treatment-related Pain
    Patient-reported pain during treatments is evaluated using the visual analog scale (VAS) where 0= no pain and 10= worst imaginable pain.
    Treatment-related Side Effects
    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.
    Investigator-reported Cosmesis (Clinical Evaluation)
    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.
    Patient-reported Cosmesis
    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
    Patients were asked to report which pretreatment they preferred: Laser, microdermabrasion, or no preference

    Full Information

    First Posted
    December 9, 2016
    Last Updated
    September 13, 2022
    Sponsor
    Bispebjerg Hospital
    Collaborators
    Galderma R&D
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03006185
    Brief Title
    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

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2016 (undefined)
    Primary Completion Date
    November 2016 (Actual)
    Study Completion Date
    March 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Bispebjerg Hospital
    Collaborators
    Galderma R&D

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Actinic Keratosis, Sun Damaged Skin, Solar Keratosis, Solar Skin Damage

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    18 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Split-Person Design: Ablative Fractional Carbon Dioxide (CO2) Laser vs Microdermabrasion
    Arm Type
    Experimental
    Arm Description
    WIthin each participant, two 50 cm2 adjacent test areas were randomized to laser or microdermabrasion pretreatment prior to daylight photodynamic therapy.
    Intervention Type
    Device
    Intervention Name(s)
    Ablative Fractional Carbon Dioxide (CO2) Laser
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Microdermabrasion
    Intervention Description
    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 Outcome Measure Information:
    Title
    Complete Clearance (%) of Actinic Keratoses (AKs)
    Description
    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.
    Time Frame
    12-15 weeks post-treatment
    Secondary Outcome Measure Information:
    Title
    New Actinic Keratoses (AKs)
    Description
    Number of new actinic keratoses (AKs) identified clinically 12-15 weeks after treatment and that were not present at the baseline evaluation.
    Time Frame
    12-15 weeks post-treatment
    Title
    Severity of Local Skin Reactions (LSRs)
    Description
    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.
    Time Frame
    Day 3-6 post treatment
    Title
    Degree of Sun Damage
    Description
    Sun damage is evaluated clinically on a 4 point scale where 0 = none, 1= mild, 2= moderate and 3= severe sun damage.
    Time Frame
    12-15 weeks post-treatment
    Title
    Treatment-related Pain
    Description
    Patient-reported pain during treatments is evaluated using the visual analog scale (VAS) where 0= no pain and 10= worst imaginable pain.
    Time Frame
    during treatment (day 0)
    Title
    Treatment-related Side Effects
    Description
    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.
    Time Frame
    up to 12-15 weeks post-treatment
    Title
    Investigator-reported Cosmesis (Clinical Evaluation)
    Description
    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.
    Time Frame
    12-15 weeks post-treatment
    Title
    Patient-reported Cosmesis
    Description
    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
    Time Frame
    12-15 weeks post-treatment
    Title
    Patient Pretreatment Preference
    Description
    Patients were asked to report which pretreatment they preferred: Laser, microdermabrasion, or no preference
    Time Frame
    12-15 weeks post-treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Merete Haedersdal, MD, Dr. Med
    Organizational Affiliation
    Bispebjerg Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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