Clinical trial · Interventional
Efficacy of AFL-assisted PDT in Microinvasive Squamous Cell Carcinoma
A Randomised Trial Comparing Methyl Aminolaevulinate Photodynamic Therapy With and Without Ablative Fractional Laser Treatment in Patients With Microinvasive Squamous Cell Carcinoma: Results From a 24-month Follow-up
NCT02666534CI-TRIAL-00020698completedPhase 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)
Surgical excision is the standard treatment for cutaneous SCC. However, many patients diagnosed with SCC are elderly and ineligible for surgery. Ablative fractional laser- assisted photodynamic therapy (AFL-PDT) offered a higher efficacy than conventional Methylaminolevulinate (MAL)-PDT.
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 |
|---|---|---|---|
| Microinvasive Squamous Cell Carcinoma | Microinvasive Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
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
- AFL-PDT
- description
- Forty-five Korean patients were enrolled in this study. 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 (21 patients) or MAL-PDT (24 patients)
- 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
- type
- ACTIVE_COMPARATOR
- label
- MAL-PDT
- description
- Forty-five Korean patients were enrolled in this study. 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 (21 patients) or MAL-PDT (24 patients)
- interventionNames
- Drug: methyl-aminolevulinate application
- Device: Illuminating using red light-emitting diode lamps
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
- Maximum age
- 89 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged 18 years or more who had previously untreated microinvasive SCC, providing they satisfied both of the following conditions: * tumor invasion into the papillary dermis (Clark level II) according to a biopsy specimen and * difficulty in surgical excision because of health problems (bleeding tendency or cardiac problems) 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 (1)
- DERIVEDChoi SH, Kim KH, Song KH. Effect of Methyl Aminolevulinate Photodynamic Therapy With and Without Ablative Fractional Laser Treatment in Patients With Microinvasive Squamous Cell Carcinoma: A Randomized Clinical Trial. JAMA Dermatol. 2017 Mar 1;153(3):289-295. doi: 10.1001/jamadermatol.2016.4463. PMID 28199463