Actinic Cheilitis, Erythroplakia, Leukoplakia
Conditions
Keywords
PDT, Actinic Cheilitis, Phase 2 Clinical Trial
Brief summary
Brazil is a tropical country, with high incidence of ultraviolet radiation throughout the year. Many Europeans migrated to Brazil escaping either war or economic crisis to live in the country searching for opportunities. Low phototype combined with high incidence of UV light is a combination that not only affect the skin but also the lips. The current study was designed to use photodynamic therapy with metil 5-aminolevulinate for actinic cheilitis in a phase 2 clinical trial.
Interventions
DRUGMetil 5-aminolevulinate
Scrubbing lip vermillion and applying the medication or placebo that is activated (or not, in case of placebo) with red light.
Sponsors
Instituto Nacional de Cancer, Brazil
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis with histopathological confirmation of actinic cheilitis * Patients will be requested to respect the timeframe of clinical consultations * No treatment for actinic cheilitis in the last 3 months
Exclusion criteria
* Histopathological diagnosis of squamous cell carcinoma (SCC) * Patient presenting any type of immunosupression * Recurrent crust of the lip vermilion (high risk of SCC)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete clinical response | 18 months | Expected complete clinical response in 60% of cases |
| Histological cure | 18 months | Expected histological cure in 40% of cases |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IHC analysis | 18 months | Expression of immunohistochemical markers of cancer progression |
Contacts
Primary ContactDaniel Cohen Goldemberg, PhD
Outcome results
None listed