Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-25 @ 2:34 AM
NCT ID:
NCT02666534
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
65 Years
Maximum Age:
89 Years
Study:
NCT02666534
Study Brief:
Protocol Section:
NCT02666534