Phase 2
N=18
Laser and Microdermabrasion Before Photodynamic Therapy for Actinic Keratoses in Field-cancerized Skin
Actinic Keratosis · Sun Damaged Skin · Solar Keratosis · Solar Skin Damage
Bottom Line
View on ClinicalTrials.gov: NCT03006185 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Sep 2022
Primary outcome: Primary: Complete Clearance (%) of Actinic Keratoses (AKs) — 81; 60 percentage (%) of AK clearance
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ablative Fractional Carbon Dioxide (CO2) Laser (Device); Microdermabrasion (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bispebjerg Hospital
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Clearance (%) of Actinic Keratoses (AKs) |
81; 60 | — |
| SECONDARY New Actinic Keratoses (AKs) |
0; 1 | — |
| SECONDARY Severity of Local Skin Reactions (LSRs) |
7; 4 | — |
| SECONDARY Degree of Sun Damage |
1; 2 | — |
| SECONDARY Treatment-related Pain |
3; 5 | — |
| SECONDARY Treatment-related Side Effects |
3; 1 | — |
| SECONDARY Investigator-reported Cosmesis (Clinical Evaluation) |
3; 2 | — |
| SECONDARY Patient-reported Cosmesis |
3; 2 | — |
| SECONDARY Patient Pretreatment Preference |
12; 4; 2 | — |
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
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.
Data sourced from ClinicalTrials.gov (NCT03006185). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.