Clinical trial · Interventional
Study of Methyl Aminolaevulinate Photodynamic Therapy With and Without Er:YAG Laser in Bowen's Disease
A Randomized, Intra-individual, Prospective Study Comparing Methyl Aminolaevulinate Photodynamic Therapy With and Without Er:YAG Ablative Fractional Laser Treatment in Asian Patients With Lower Extremity Bowen's Disease
- 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)
Methyl aminolaevulinate photodynamic therapy (MAL-PDT) is an effective treatment for Bowen's disease (BD) of the lower extremities. Er:YAG ablative fractional laser (AFL) treatment removes the stratum corneum to increase MAL uptake and may improve efficacy. However, no studies have directly compared the efficacy of MAL-PDT with and without Er:YAG AFL in treating BD of the lower extremities in Asians.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Er:YAG AFL-PDT | Drug | — | UNRESOLVED |
| MAL-PDT | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Er:YAG AFL-PDT
- description
- Right leg on each patients was assigned a single session of Er:YAG AFL-PDT.
- interventionNames
- Drug: Er:YAG AFL-PDT
- type
- ACTIVE_COMPARATOR
- label
- MAL-PDT
- description
- Left leg on each patient was selected to receive 2 sessions of MAL-PDT
- interventionNames
- Drug: MAL-PDT
Primary outcomes (1)
- measure
- Difference the efficacy between Er:YAG AFL-assisted MAL-PDT (Er:YAG AFL-PDT) and standard MAL-PDT.
- timeFrame
- Efficacy was evaluated at 3 months and 12 months after treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 92 Years
Show eligibility criteria text
Inclusion Criteria: * Korean patients aged ≥ 18 years who had biopsy-confirmed BD lesions on the lower extremities Exclusion Criteria: * porphyria, * known allergies to the MAL cream or lidocaine, * pregnancy, * lactation, * any active systemic infectious disease, * immunosuppressive treatment, * personal history of malignant melanoma, * tendency towards melasma or keloid formation, * prior treatment of the lesions within 4 weeks, and * any indication of poor compliance
References
Publications (0)
Data not yet available