Comparison of two treatment options for patients with precursor lesions of skin cancer: colchicine cream versus 5-FU cream

Phase 2

• Conditions: Actinic keratosis; L57.0

• Registration Number: RBR-487ctp
• Lead Sponsor: Instituto Lauro de Souza Lima (ILSL)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-03
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Sign the Informed Consent Form; age over 18 years, both sexes; present a minimum of 3 and a maximum of 10 lesions clinically compatible with AK on each dorsal face of the forearm.

Exclusion Criteria

treatment area that has an atypical clinical appearance, suggestive of carcinoma, or other extensive dermatoses; current and / or previous clinical diagnosis or evidence of any medical condition that exposes the patient to increased risks, interferes with the safety or efficacy of the proposed treatment; present hypersensitivity or allergy to any of the substances under study; patients using any systemic or topical immunosuppressive substance, oral retinoid, in addition to other local treatments (eg: corticosteroids, anti-inflammatories, topical retinoids); patients who have received any type of treatment for skin field cancerization less than 6 months before the start of the study; immunocompromised individuals; coagulation disorders; suspected or confirmed pregnancy; women of childbearing potential who do not use contraception; women who are breastfeeding. Discontinuation criteria: withdrawal of consent; presence of infection (erysipelas, cellulitis or abscess) during follow-up in the treatment areas; loss of follow-up; use of other AK treatment methods other than the one proposed; serious adverse event, at the investigator's discretion; pregnancy during follow-up; failure to take photographic images of the lesions on the days determined before the start of treatment.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
It is expected to find complete resolution of all actinic keratoses within the area treated with colchicine cream by counting the number of lesions before and after treatment.