RBR-487ctp
Not Yet Recruiting
Phase 2
Clinical and dermatoscopic evaluation of the effectiveness of Colchicine 0,5% cream versus 5-Fluorouracil 5% cream in the treatment of Actinic Keratosis and Cutaneous Cancerization Field: a randomized clinical trial
Instituto Lauro de Souza Lima (ILSL)0 sitesMarch 3, 2020
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Actinic keratosis
- Sponsor
- Instituto Lauro de Souza Lima (ILSL)
- Status
- Not Yet Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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