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5-fluorouracil 5% compared to vitamin b3 in the treatment of precancerous skin changes

5- fluorouracil 5% intermittent versus nicotinamide at the treatment cancerization skin field: a clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-9rjg3g
Enrollment
Unknown
Registered
2016-11-24
Start date
2015-08-26
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Actinic keratosis

Interventions

experimental group: 18 patients with three to ten actinic keratoses by forearm will be evaluated clinically (keratoses count actinic and aging assessment of the forearms), biopsied, and receive topica
Drug
Other

Sponsors

Faculdade de Medicina de Botucatu - UNESP
Lead Sponsor
Faculdade de Medicina de Botucatu - UNESP
Collaborator

Eligibility

Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Brazil

Contacts

Public ContactEliane Ferreira

Faculdade de Medicina de Botucatu - UNESP

eliane_roio@yahoo.com.br55-14-988268382

Outcome results

None listed

Source: REBEC (via WHO ICTRP)