Clinical trial · Interventional
New Treatments for Actinic Keratoses of the Scalp
NCT05456334CI-TRIAL-00071554unknownN/AClinicalTrials.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)
This blinded controlled 2-year study on 120 patients with 2 or more actinic keratoses, compare the efficacy and tolerability of pulsed dye-laser- mediated photodynamic therapy compared to conventional photodynamic therapy and fractional-laser assisted daylight photodynamic therapy compared to daylight photodynamic therapy.
Conditions
Conditions (2)
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 Keratoses | — | UNRESOLVED | — |
| Photodamaged Skin | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fractional CO2-laser | Device | — | UNRESOLVED |
| Metvix cream | Drug | Methyl Aminolevulinate | ALIAS |
| Pulsed-dye laser | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Pulsed dye laser-mediated photodynamic therapy
- description
- After curretage light-sensitizer (methyl aminolaevulinate cream) was applied on the lesions and covered with an occlusive plastic foil for 2-3-h incubation. Then a local lidocaine anaesthetic spray was applied. The lesions were illuminated with 30% overlapping pulsed laser double-stacked pulses (, energy 7 J/cm2, spot size 7 mm, pulse duration 10 ms, wavelength 595 nm and dynamic cooling 2/3).
- interventionNames
- Device: Pulsed-dye laser
- Drug: Metvix cream
- type
- ACTIVE_COMPARATOR
- label
- Conventional photodynamic therapy
- description
- After curretage a light-sensitizer (methyl aminolaevulinate cream) was applied on the lesions and covered with an occlusive plastic foil for 2-3-h incubation. Then a local lidocaine anaesthetic spray was applied. The lesions were illuminated with a red LED light for 7-8 min (exposure 75 J/cm2, wavelength 630 nm).
- interventionNames
- Drug: Metvix cream
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * at least 2 AKs located on both sides of the head (either the scalp, forehead, temples, or cheeks) Exclusion Criteria: * pigmented AKs, in situ-carcinomas, skin cancers, psoriasis or eczema on the treatment area
References
Publications (0)
Data not yet available
No reference posted for this study.