Clinical trial · Interventional
Efficacy in Ablative Fractional Laser Assisted Photodynamic Therapy According to Ablative Depth for Actinic Keratosis
NCT03325803CI-TRIAL-00030138completedPhase 1ClinicalTrials.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)
Er:YAG ablative fractional laser-assisted photodynamic therapy (AFL-PDT) has shown significant benefit for the treatment of actinic keratosis(AK). Er:YAG ablative fractional laser ablates the epidermis and dermis without significant thermal injury, creating microscopic ablation zones (MAZ) in the portion of the skin that the laser is applied to. The formed MAZ depends on the laser parameters such as laser depth, laser density and laser passes, which affect the treatment outcome.
Conditions
Conditions (1)
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 Dermatosis | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 2940-nm Er:YAG AFL pretreatment | Device | — | UNRESOLVED |
| irradiation with red light-emitting diode lamp | Device | — | UNRESOLVED |
| lidocaine/prilocaine (5%) application | Drug | — | UNRESOLVED |
| MAL application | Drug | — | UNRESOLVED |
| Measurements of the fluorescence intensity | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- 150μm-AFL-PDT
- interventionNames
- Drug: lidocaine/prilocaine (5%) application
- Device: 2940-nm Er:YAG AFL pretreatment
- Drug: MAL application
- Other: Measurements of the fluorescence intensity
- Device: irradiation with red light-emitting diode lamp
- type
- EXPERIMENTAL
- label
- 350μm-AFL-PDT
- interventionNames
- Drug: lidocaine/prilocaine (5%) application
- Device: 2940-nm Er:YAG AFL pretreatment
- Drug: MAL application
- Other: Measurements of the fluorescence intensity
- Device: irradiation with red light-emitting diode lamp
- type
- EXPERIMENTAL
- label
- 500μm-AFL-PDT
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Korean patients aged ≥ 18 years who had biopsy-confirmed Actinic keratosis lesions Exclusion Criteria: * photosensitivity disorder patients * lactating or pregnant women * patients with porphyria or a known allergy to any of the constituents of the MAL cream and lidocaine * patients with systemic disease, history of malignant melanoma, tendency of melasma development or keloid formation, any AK treatment of the area in the previous 4 weeks, or any conditions associated with a risk of poor protocol compliance; and patients on immunosuppressive treatment
References
Publications (0)
Data not yet available
No reference posted for this study.