Trial Outcomes & Findings for Laser and Microdermabrasion Before Photodynamic Therapy for Actinic Keratoses in Field-cancerized Skin (NCT NCT03006185)
NCT ID: NCT03006185
Last Updated: 2022-09-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
12-15 weeks post-treatment
Results posted on
2022-09-28
Participant Flow
Unit of analysis: Test areas
Participant milestones
| Measure |
Split-Person Design: Ablative Fractional Carbon Dioxide (CO2) Laser vs Microdermabrasion
Intra-individual design. "All study participants" are grouped into a single arm. Two adjacent skin areas (test areas) on each participant was allocated through randomization to two different interventions: 1) Pretreatment with Ablative Fractional (AFL) CO2 laser OR 2) Microdermabrasion (MD) prior to standard daylight photodynamic therapy.
Description of intervention: Ablative Fractional CO2 laser: CO2 laser treatment is randomly allocated to one of two tests areas within each study participant. Laser treatment consists of targeted ablation of actinic keratoses and field laser treatment of the entire test area. After laser treatment, application of methyl aminolevulinate (MAL), a topical photosensitizing agent, is performed. The test area thereafter undergoes 2 hours of daylight photodynamic therapy.
Microdermabrasion: Microdermabrasion (processing of the skin with a sandpaper-like material) is randomly allocated to one of two tests areas in each study participant. Microdermabrasion treatment consists of targeted treatment of actinic keratoses and field treatment of the entire test area. Afterwards, application of methyl aminolevulinate (MAL), a topical photosensitizing agent, is performed. The test area then undergoes 2 hours of daylight photodynamic therapy.
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Overall Study
STARTED
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18 36
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Overall Study
Number of Test Areas Recieving AFL
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18 36
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Overall Study
Number of Test Areas Receiving MD
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18 36
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Overall Study
COMPLETED
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18 36
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Overall Study
NOT COMPLETED
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0 0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Laser and Microdermabrasion Before Photodynamic Therapy for Actinic Keratoses in Field-cancerized Skin
Baseline characteristics by cohort
| Measure |
Split Person Design: Pretreatment With Ablative Fractional Carbon Dioxide Laser or Microdermabrasion
n=36 Skin areas
Two 50 cm2 test areas (Test Area A and B) are demarcated on the skin of each study participant. One test area is randomized to receive the intervention: Ablative Fractional Carbon Dioxide (CO2) Laser prior to standard daylight photodynamic therapy. The other test area is randomized to receive the intervention: microdermabrasion prior to standard daylight photodynamic therapy.
Ablative Fractional Carbon Dioxide (CO2) Laser: Ablative Fractional Carbon Dioxide (CO2) Laser treatment is randomly allocated to one of two tests areas in each study participant. Laser treatment consists of targeted ablation of actinic keratoses and field laser treatment of the entire test area. After laser treatment, application of methyl aminolevulinate (MAL), a topical photosensitising agent, is performed. The test area thereafter undergoes 2 hours of daylight photodynamic therapy.
Microdermabrasion: Microdermabrasion (processing of the skin with a sandpaper-like material) is randomly allocated to one of two tests areas in each study participant. Microdermabrasion treatment consists of targeted treatment of actinic keratoses and field treatment of the entire test area. Afterwards, application of methyl aminolevulinate (MAL), a topical photosensitising agent, is performed. The test area then undergoes 2 hours of daylight photodynamic therapy.
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Age, Categorical
<=18 years
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0 Participants
n=99 Participants
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Age, Categorical
Between 18 and 65 years
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3 Participants
n=99 Participants
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Age, Categorical
>=65 years
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15 Participants
n=99 Participants
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Age, Continuous
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72.5 years
n=99 Participants
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Sex: Female, Male
Female
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6 Participants
n=99 Participants
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Sex: Female, Male
Male
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12 Participants
n=99 Participants
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Region of Enrollment
Denmark
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18 participants
n=99 Participants
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PRIMARY outcome
Timeframe: 12-15 weeks post-treatmentPopulation: Percentage AK clearance in test areas receiving either AFL (18) or microdermabrasion (18) assisted daylight PDT 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.
Outcome measures
| Measure |
Split-Person Design: Ablative Fractional Carbon Dioxide (CO2) Laser vs Microdermabrasion
n=36 Test areas
Intra-individual design of 18 participants. "All study participants" are grouped into a single arm. Two adjacent skin areas (test areas) on each participant is allocated through randomization to two different interventions: 1) Pretreatment with Ablative Fractional (AFL) CO2 laser OR 2) Microdermabrasion (MD) prior to standard daylight photodynamic therapy. Thus, each participants received both inventions (18 test areas received AFL and 18 test areas received MD).
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Complete Clearance (%) of Actinic Keratoses (AKs)
Ablative Fractional Laser
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81 percentage (%) of AK clearance
Interval 53.0 to 100.0
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Complete Clearance (%) of Actinic Keratoses (AKs)
Microdermabrasion
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60 percentage (%) of AK clearance
Interval 24.0 to 94.0
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SECONDARY outcome
Timeframe: 12-15 weeks post-treatmentNumber of new actinic keratoses (AKs) identified clinically 12-15 weeks after treatment and that were not present at the baseline evaluation.
Outcome measures
| Measure |
Split-Person Design: Ablative Fractional Carbon Dioxide (CO2) Laser vs Microdermabrasion
n=36 Test areas
Intra-individual design of 18 participants. "All study participants" are grouped into a single arm. Two adjacent skin areas (test areas) on each participant is allocated through randomization to two different interventions: 1) Pretreatment with Ablative Fractional (AFL) CO2 laser OR 2) Microdermabrasion (MD) prior to standard daylight photodynamic therapy. Thus, each participants received both inventions (18 test areas received AFL and 18 test areas received MD).
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New Actinic Keratoses (AKs)
Ablative Fractional Laser
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0 New AK lesions
Interval 0.0 to 0.25
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New Actinic Keratoses (AKs)
Microdermabrasion
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1 New AK lesions
Interval 0.0 to 2.0
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SECONDARY outcome
Timeframe: Day 3-6 post treatmentLocal 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.
Outcome measures
| Measure |
Split-Person Design: Ablative Fractional Carbon Dioxide (CO2) Laser vs Microdermabrasion
n=36 Test areas
Intra-individual design of 18 participants. "All study participants" are grouped into a single arm. Two adjacent skin areas (test areas) on each participant is allocated through randomization to two different interventions: 1) Pretreatment with Ablative Fractional (AFL) CO2 laser OR 2) Microdermabrasion (MD) prior to standard daylight photodynamic therapy. Thus, each participants received both inventions (18 test areas received AFL and 18 test areas received MD).
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Severity of Local Skin Reactions (LSRs)
Ablative Frational Laser
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7 score on a scale
Interval 5.0 to 10.0
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Severity of Local Skin Reactions (LSRs)
Microdermabrasion
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4 score on a scale
Interval 2.0 to 6.0
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SECONDARY outcome
Timeframe: 12-15 weeks post-treatmentSun damage is evaluated clinically on a 4 point scale where 0 = none, 1= mild, 2= moderate and 3= severe sun damage.
Outcome measures
| Measure |
Split-Person Design: Ablative Fractional Carbon Dioxide (CO2) Laser vs Microdermabrasion
n=36 Skin Areas
Intra-individual design of 18 participants. "All study participants" are grouped into a single arm. Two adjacent skin areas (test areas) on each participant is allocated through randomization to two different interventions: 1) Pretreatment with Ablative Fractional (AFL) CO2 laser OR 2) Microdermabrasion (MD) prior to standard daylight photodynamic therapy. Thus, each participants received both inventions (18 test areas received AFL and 18 test areas received MD).
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Degree of Sun Damage
Ablative Fractional Laser
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1 score on a scale
Interval 0.0 to 2.0
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Degree of Sun Damage
Microdermabrasion
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2 score on a scale
Interval 1.0 to 2.25
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SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Split-Person Design: Ablative Fractional Carbon Dioxide (CO2) Laser vs Microdermabrasion
n=18 Participants
Intra-individual design of 18 participants. "All study participants" are grouped into a single arm. Two adjacent skin areas (test areas) on each participant is allocated through randomization to two different interventions: 1) Pretreatment with Ablative Fractional (AFL) CO2 laser OR 2) Microdermabrasion (MD) prior to standard daylight photodynamic therapy. Thus, each participants received both inventions (18 test areas received AFL and 18 test areas received MD).
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Treatment-related Pain
Microdermabrasion
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5 units on a scale
Interval 4.0 to 6.0
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Treatment-related Pain
Ablative Fractional Laser
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3 units on a scale
Interval 2.0 to 4.0
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SECONDARY outcome
Timeframe: up to 12-15 weeks post-treatmentSide 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.
Outcome measures
| Measure |
Split-Person Design: Ablative Fractional Carbon Dioxide (CO2) Laser vs Microdermabrasion
n=36 Test areas
Intra-individual design of 18 participants. "All study participants" are grouped into a single arm. Two adjacent skin areas (test areas) on each participant is allocated through randomization to two different interventions: 1) Pretreatment with Ablative Fractional (AFL) CO2 laser OR 2) Microdermabrasion (MD) prior to standard daylight photodynamic therapy. Thus, each participants received both inventions (18 test areas received AFL and 18 test areas received MD).
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Treatment-related Side Effects
Ablative Fractional Laser
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3 Local Staf infection
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Treatment-related Side Effects
Microdermabrasion
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1 Local Staf infection
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SECONDARY outcome
Timeframe: 12-15 weeks post-treatmentCosmetic 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.
Outcome measures
| Measure |
Split-Person Design: Ablative Fractional Carbon Dioxide (CO2) Laser vs Microdermabrasion
n=36 Test areas
Intra-individual design of 18 participants. "All study participants" are grouped into a single arm. Two adjacent skin areas (test areas) on each participant is allocated through randomization to two different interventions: 1) Pretreatment with Ablative Fractional (AFL) CO2 laser OR 2) Microdermabrasion (MD) prior to standard daylight photodynamic therapy. Thus, each participants received both inventions (18 test areas received AFL and 18 test areas received MD).
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Investigator-reported Cosmesis (Clinical Evaluation)
Ablative Fractional Laser
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3 score on a scale
Interval 2.0 to 3.0
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Investigator-reported Cosmesis (Clinical Evaluation)
Microdermabrasion
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2 score on a scale
Interval 1.5 to 2.0
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SECONDARY outcome
Timeframe: 12-15 weeks post-treatmentCosmetic 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
Outcome measures
| Measure |
Split-Person Design: Ablative Fractional Carbon Dioxide (CO2) Laser vs Microdermabrasion
n=36 Test areas
Intra-individual design of 18 participants. "All study participants" are grouped into a single arm. Two adjacent skin areas (test areas) on each participant is allocated through randomization to two different interventions: 1) Pretreatment with Ablative Fractional (AFL) CO2 laser OR 2) Microdermabrasion (MD) prior to standard daylight photodynamic therapy. Thus, each participants received both inventions (18 test areas received AFL and 18 test areas received MD).
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Patient-reported Cosmesis
Ablative Fractional Laser
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3 score on a scale
Interval 2.0 to 3.0
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Patient-reported Cosmesis
Microdermabrasion
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2 score on a scale
Interval 1.0 to 2.0
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SECONDARY outcome
Timeframe: 12-15 weeks post-treatmentPatients were asked to report which pretreatment they preferred: Laser, microdermabrasion, or no preference
Outcome measures
| Measure |
Split-Person Design: Ablative Fractional Carbon Dioxide (CO2) Laser vs Microdermabrasion
n=18 Participants
Intra-individual design of 18 participants. "All study participants" are grouped into a single arm. Two adjacent skin areas (test areas) on each participant is allocated through randomization to two different interventions: 1) Pretreatment with Ablative Fractional (AFL) CO2 laser OR 2) Microdermabrasion (MD) prior to standard daylight photodynamic therapy. Thus, each participants received both inventions (18 test areas received AFL and 18 test areas received MD).
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Patient Pretreatment Preference
No Preference
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2 Participants
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Patient Pretreatment Preference
Ablative Fractional Laser
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12 Participants
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Patient Pretreatment Preference
Microdermabrasion
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4 Participants
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Adverse Events
Split-Person: Ablative Fractional Carbon Dioxide Laser or Microdermabrasion
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Split-Person: Ablative Fractional Carbon Dioxide Laser or Microdermabrasion
n=18 participants at risk
Intra-individual design of 18 participants. "All study participants" are grouped into a single arm. Two adjacent skin areas (test areas) on each participant is allocated through randomization to two different interventions: 1) Pretreatment with Ablative Fractional (AFL) CO2 laser OR 2) Microdermabrasion (MD) prior to standard daylight photodynamic therapy. Thus, each participants receives both inventions (18 test areas received AFL and 18 test areas received MD).
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Infections and infestations
Infection in test areas treated with AFL
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16.7%
3/18 • Number of events 3
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Infections and infestations
Infection in test areas treated with MD
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5.6%
1/18 • Number of events 1
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place