Efficacy of AFL-assisted PDT in Microinvasive Squamous Cell Carcinoma

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Dong-A University
• Treatments: Aminolevulinic Acid; EMLA; Lidocaine; Lidocaine, Prilocaine Drug Combination; Methyl 5-aminolevulinate; Prilocaine

Criteria

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