Clinical trial · Interventional
Long-term Efficacy of Ablative Fractional Laser-assisted Photodynamic Therapy for Treatment of Lower Extremity Bowen's Disease
Long-term Efficacy of Ablative Fractional Laser-assisted Photodynamic Therapy for Treatment of Lower Extremity Bowen's Disease: A Prospective, Randomized, Controlled Trial With 5-year Follow up
- 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 methyl aminolevulinate photodynamic therapy (AFL-PDT) has shown significantly higher efficacy and a lower recurrence rate at 12 months than methyl aminolevulinate photodynamic therapy (MAL-PDT) for treatment of Bowen's disease (BD). However, long-term follow up data are not available.
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 |
|---|---|---|---|
| Bowen's Disease | Squamous Cell Carcinoma In Situ | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 2940-nm Er:YAG AFL pretreatment | Device | — | UNRESOLVED |
| Illuminating using red light-emitting diode lamps | Device | — | UNRESOLVED |
| lidocaine-prilocaine 5% cream application | Drug | — | UNRESOLVED |
| methyl-aminolevulinate application | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- MAL-PDT
- description
- Patients were randomly assigned to receive either AFL-PDT or MAL-PDT in a 1:1 ratio. As result, the patients were randomized to treatment with AFL-PDT or MAL-PDT
- interventionNames
- Drug: methyl-aminolevulinate application
- Device: Illuminating using red light-emitting diode lamps
- type
- EXPERIMENTAL
- label
- AFL-PDT
- description
- Patients were randomly assigned to receive either AFL-PDT or MAL-PDT in a 1:1 ratio. As result, the patients were randomized to treatment with AFL-PDT or MAL-PDT
- interventionNames
- Drug: lidocaine-prilocaine 5% cream application
- Device: 2940-nm Er:YAG AFL pretreatment
- Drug: methyl-aminolevulinate application
- Device: Illuminating using red light-emitting diode lamps
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 42 Years
- Maximum age
- 89 Years
Show eligibility criteria text
Inclusion Criteria: * •Patients aged 18 years or more who diagnosed as bowen's disease Exclusion Criteria: * pregnancy or lactation * active systemic infectious disease * other inflammatory, infectious, or neoplastic skin diseases in the treated area * allergy to MAL,other topical photosensitizers, or excipients of the cream * history of photosensitivity * use of immunosuppressive or photosensitizing drugs * participation in any other investigational study in the preceding 30 days * history or indicators of poor compliance * Histological findings of acantholysis, desmoplasia, perineural or lymphovascular invasion, and echographic features of regional lymph node metastasis were the disease-specific exclusion criteria
References
Publications (0)
Data not yet available