Efficacy of AFL-assisted PDT in Microinvasive Squamous Cell Carcinoma
Launched by DONG-A UNIVERSITY · Jan 27, 2016
Trial Information
Current as of May 07, 2025
Completed
Keywords
ClinConnect Summary
Squamous cell carcinoma (SCC) lesions are potentially metastatic and can be life threatening. Hence, surgical excision is the standard treatment for cutaneous SCC. However, some patients are ineligible for surgery because of their poor general health, concomitant anticoagulant or immunosuppressive therapies, or allergy to local anesthetics.
Photodynamic therapy (PDT) with methylaminolevulinate (MAL) is an innovative treatment modality that has been approved in Europe for the treatment of actinic keratosis, basal cell carcinoma, and Bowen's disease. However, currently, there is insufficient...
Gender
ALL
Eligibility 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
About Dong A University
Dong-A University is a prestigious academic institution located in Busan, South Korea, renowned for its commitment to advancing medical research and education. The university actively engages in innovative clinical trials aimed at enhancing healthcare outcomes and addressing pressing medical challenges. With a focus on multidisciplinary collaboration, Dong-A University leverages its state-of-the-art facilities and expert faculty to conduct rigorous research, ensuring adherence to ethical standards and regulatory compliance. The institution is dedicated to translating scientific discoveries into practical applications that benefit patients and the broader community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Busan, Dong Dae Sin Dong, Seo Gu, Korea, Republic Of
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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