5-fluorouracil 5% compared to vitamin b3 in the treatment of precancerous skin changes
- Conditions
- Actinic keratosisL57.0
- Registration Number
- RBR-9rjg3g
- Lead Sponsor
- Faculdade de Medicina de Botucatu - UNESP
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
Age above 18 years of both sexes; provide at least three and no more than ten clinically compatible with actinic keratosis lesions on each forearm bilaterally.
Selected treatment area that has atypical clinical appearance or other extensive dermatoses forearms; current and previous clinical diagnosis or evidence of any medical condition that expose the patient to increased risk, interfere with the safety or efficacy of the proposed treatment; present hypersensitivity or allergy to any of the substances under study; use of topical or systemic immunosuppressive substance, oral retinoid, and other local treatments (eg corticosteroids, anti-inflammatories, retinoids); immunocompromised; pregnancy suspected or confirmed; women of childbearing potential not using contraception; women in breastfeeding; coagulation disorders.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction or disappearance of actinic keratoses. Evaluation will be done by counting the number of actinic keratoses, immunohistochemistry, and histology of skin biopsies. As evaluation parameters will be used index tables for counting actinic keratoses, and description of histologic atypia and expression of p53 and Ki67 by pathologist.
- Secondary Outcome Measures
Name Time Method Adverse effects related to the proposed treatment, appearance of skin tumors non-melanoma and tolerability. The evaluation will be questionmento by the researcher to the patient for adverse effects and tolerabiliade, and clinical evaluation for detection of new tumors by physical examination.