Actinic KeratosisPhase 2NCT03006185
Laser and Microdermabrasion Before Photodynamic Therapy for Actinic Keratoses in Field-cancerized Skin
A Phase 2 study testing Ablative Fractional Carbon Dioxide (CO2) Laser and Microdermabrasion in people with Actinic Keratosis and Sun Damaged Skin, run by Bispebjerg Hospital.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratosis, Sun Damaged Skin, Solar Keratosis
- What is being tested?
- Ablative Fractional Carbon Dioxide (CO2) Laser and Microdermabrasion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to 1 Mar 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Pretreatment With Ablative Fractional 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
Read the 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.
- Being tested
- Ablative Fractional Carbon Dioxide (CO2) Laser, Microdermabrasion
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ablative Fractional Carbon Dioxide (CO2) LaserDevice
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.
MicrodermabrasionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Split-Person Design: Ablative Fractional Carbon Dioxide (CO2) Laser vs Microdermabrasion | Experimental | WIthin each participant, two 50 cm2 adjacent test areas were randomized to laser or microdermabrasion pretreatment prior to daylight photodynamic therapy. Receives: Device: Ablative Fractional Carbon Dioxide (CO2) Laser; Device: Microdermabrasion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12-15 weeks post-treatment
Secondary outcomes (8)
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.
Measured: 12-15 weeks post-treatment
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.
Measured: Day 3-6 post treatment
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.
Measured: 12-15 weeks post-treatment
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.
Measured: during treatment (day 0)
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.
Measured: up to 12-15 weeks post-treatment
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.
Measured: 12-15 weeks post-treatment
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
Measured: 12-15 weeks post-treatment
Patient Pretreatment Preference
Patients were asked to report which pretreatment they preferred: Laser, microdermabrasion, or no preference
Measured: 12-15 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2016 (estimated)
- Study startAug 2016
- Primary completionNov 2016
- Study completion1 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Actinic KeratosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Galderma R&D
- Responsible party
- Principal investigator, Merete Haedersdal, Bispebjerg Hospital
- Investigators
- Merete Haedersdal, MD, Dr. Med, Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03006185
- Sponsor's protocol ID
- H-16023991
- Other IDs
- 2015-002331-18, 2015
- Status last verified
- Sep 2022
- First submitted
- 9 Dec 2016
- Last updated
- 28 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pretreatment With Ablative Fractional Laser and Microdermabrasion Before Photodynamic Therapy for Actinic Keratoses in Field-cancerized Skin
- ClinicalTrials.gov ID
- NCT03006185
- Acronym / sponsor ID
- H-16023991
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- Galderma R&D
- Study start
- Aug 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 30 Dec 2016 (estimated)
- Results
- Posted 28 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Split-Person Design: Ablative Fractional Carbon Dioxide (CO2) Laser vs Microdermabrasion | Experimental | Device: Ablative Fractional Carbon Dioxide (CO2) Laser, Device: MicrodermabrasionWIthin each participant, two 50 cm2 adjacent test areas were randomized to laser or microdermabrasion pretreatment prior to daylight photodynamic therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ablative Fractional Carbon Dioxide (CO2) LaserOne 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. | Device | Split-Person Design: Ablative Fractional Carbon Dioxide (CO2) Laser vs Microdermabrasion |
| MicrodermabrasionAnother 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. | Device | Split-Person Design: Ablative Fractional Carbon Dioxide (CO2) Laser vs Microdermabrasion |
Primary outcome
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.
8 secondary outcomes
New Actinic Keratoses (AKs)
Time frame: 12-15 weeks post-treatment
Severity of Local Skin Reactions (LSRs)
Time frame: Day 3-6 post treatment
Degree of Sun Damage
Time frame: 12-15 weeks post-treatment
Treatment-related Pain
Time frame: during treatment (day 0)
Treatment-related Side Effects
Time frame: up to 12-15 weeks post-treatment
Investigator-reported Cosmesis (Clinical Evaluation)
Time frame: 12-15 weeks post-treatment
Patient-reported Cosmesis
Time frame: 12-15 weeks post-treatment
Patient Pretreatment Preference
Time frame: 12-15 weeks post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merete Haedersdal, MD, Dr. Med principal investigator
Bispebjerg Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ablative Fractional Carbon Dioxide (CO2) Laser and Microdermabrasion in people with Actinic Keratosis and Sun Damaged Skin, run by Bispebjerg Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Clearance (%) of Actinic Keratoses (AKs) (time frame: 12-15 weeks post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022.