- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03006185
Laser and Microdermabrasion Before Photodynamic Therapy for Actinic Keratoses in Field-cancerized Skin
Pretreatment With Ablative Fractional Laser and Microdermabrasion Before Photodynamic Therapy for Actinic Keratoses in Field-cancerized Skin
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Split-Person Design: Ablative Fractional Carbon Dioxide (CO2) Laser vs Microdermabrasion
WIthin each participant, two 50 cm2 adjacent test areas were randomized to laser or microdermabrasion pretreatment prior to daylight photodynamic therapy.
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12-15 weeks post-treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12-15 weeks post-treatment
|
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. |
Day 3-6 post treatment
|
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.
|
12-15 weeks post-treatment
|
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.
|
during treatment (day 0)
|
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.
|
up to 12-15 weeks post-treatment
|
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.
|
12-15 weeks post-treatment
|
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
|
12-15 weeks post-treatment
|
Patient Pretreatment Preference
Time Frame: 12-15 weeks post-treatment
|
Patients were asked to report which pretreatment they preferred: Laser, microdermabrasion, or no preference
|
12-15 weeks post-treatment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Merete Haedersdal, MD, Dr. Med, Bispebjerg Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-16023991
- 2015-002331-18 (EUDRACT_NUMBER)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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