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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
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.
Details
| Lead sponsor | Dong-A University |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 45 |
| Start date | 2012-01 |
| Completion | 2015-12 |
Conditions
- Microinvasive Squamous Cell Carcinoma
Interventions
- lidocaine-prilocaine 5% cream application
- 2940-nm Er:YAG AFL pretreatment
- methyl-aminolevulinate application
- Illuminating using red light-emitting diode lamps
Primary outcomes
- Difference of short-term complete response (CR) rate between AFL-PDT and MAL-PDT — Short-term CR rate was evaluated at 3 months
The response was classified as either complete response (complete disappearance of the lesion) or incomplete response (incomplete disappearance of the lesion) - Difference of long-term complete response (CR) rate between AFL-PDT and MAL-PDT — Long-term CR rate was evaluated at 24 months
The response was classified as either complete response (complete disappearance of the lesion) or incomplete response (incomplete disappearance of the lesion) - Difference of recurrence rate at 24 months — Recurrent rate was evaluated at 24months
In all cases of complete response, the patients were reviewed at 24 months to check for recurrence. Post-therapy punch biopsies were performed when there was doubt concerning incomplete-response and clinical recurrence
Countries
South Korea