Actinic keratosis
Conditions
Interventions
Each one of the 45 patients will receive one of two treatments on each forearm. One forearm from each research subject will receive Colchicine 0.5% cream twice a day for 07 days while the other forear
Drug
Sponsors
Instituto Lauro de Souza Lima (ILSL)
Faculdade de Medicina da Universidade Estadual Paulista (FMB-UNESP)
Eligibility
Inclusion 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
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the incomplete reduction in the count of the number of actinic keratoses, but that represents more than 75% of resolution, through the count of lesions before and after treatment;Check if there was improvement in the dermatoscopic findings of actinic keratoses after treatment, by examining the treated area with the aid of a dermatoscope;Check the profile of adverse effects of the medications used in the study through a dermatological consultation that will be carried out after 14 days of starting treatments. The following aspects will be evaluated: presence of erythema, local pain, edema, desquamation and other complaints that patients may describe;Check if there will be the appearance of non-melanoma skin cancer in the treated areas through dermatological examination performed after 14 and 90 days after the beginning of treatment;Assess whether there will be a reduction in the severity score of actinic keratoses by comparing the score obtained by the same patient at the beginning and at the end of the research | — |
Countries
Brazil
Contacts
Public ContactAmanda Teixeira
Instituto Lauro de Souza Lima (ILSL)
Outcome results
None listed