Clinical trial · Interventional
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
NCT03006185CI-TRIAL-00061104completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Actinic Keratosis | — | UNRESOLVED | — |
| Solar Keratosis | — | UNRESOLVED | — |
| Solar Skin Damage | — | UNRESOLVED | — |
| Sun Damaged Skin | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ablative Fractional Carbon Dioxide (CO2) Laser | Device | — | UNRESOLVED |
| Microdermabrasion | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Split-Person Design: Ablative Fractional Carbon Dioxide (CO2) Laser vs Microdermabrasion
- description
- WIthin each participant, two 50 cm2 adjacent test areas were randomized to laser or microdermabrasion pretreatment prior to daylight photodynamic therapy.
- interventionNames
- Device: Ablative Fractional Carbon Dioxide (CO2) Laser
- Device: Microdermabrasion
Primary outcomes (1)
- measure
- Complete Clearance (%) of Actinic Keratoses (AKs)
- timeFrame
- 12-15 weeks post-treatment
- 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.
Secondary outcomes (8)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.