Actinic keratosis Skin Field cancerization
Conditions
Interventions
A study of 36 patients, who will be randomly receive one of the following on each forearm, forearms totaling 72 (36 with colchicine and 36 with photodynamic therapy) .The patients will be informed abo
or MAL -TFD after curettage. an ointment layer containing hydrochloride aminulevulato methyl in the affected area and occluded with PVC film and aluminum foil is applied. The occlusion time is 3 hours
Drug
Procedure/surgery
E07.632.490
Sponsors
Faculdade de Medicina - Unesp Botucatu
Faculdade de Medicina - Unesp Botucatu
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Sign the Statement of Consent. 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.
Exclusion criteria
Exclusion criteria: Lesions in fewer than three or greater than ten in each forearm. Selected treatment area that has atypical clinical appearance or other extensive dermatoses forearms . Current and previous clinical diagnosis or evidence of other diseases . Display hypersensitivity or allergy to any of subustâncias study . Patients using any topical or systemic immunosuppressive substance . Use of other skin treatment. Immunocompromised individuals . Coagulation disorders . Pregnancy suspected or confirmed. Women of childbearing potential not using contraception. Women breast-feeding .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete clearance rate of AK when treated with colchicine and MAL- PDT in T60 , ie , the absence of actinic keratoses on clinical examination after 60 days of treatment with colchicine or MAL -PDT , by the number of actinic keratoses count , evaluation the severity score of actinic keratoses and photoaging scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| Partial clearance rate of AK when treated with colchicine and MAL -PDT compared T0 to T60 , with expected reduction of at least 30 % in the amount of actinic keratoses . Modification of histologic atypia profile between treatments comparing T0 to T60 , made ??by histopathology . Modification of the expression of p53 and Ki67 between treatments comparing T0 to T60 , waiting for reducing the expression of p53 and Ki67 after the intervention. adverse effects assessment related to the proposed treatment : impact of local events and severity . Emergence of non-melanoma skin tumors by clinical evaluation. Tolerability through a questionnaire applied to the patient. | — |
Countries
Brazil
Contacts
Public ContactAnna;Helio Miola;Miot
Faculdade de Medicina - Unesp Botucatu;Faculdade de Medicina - Unesp Botucatu
Outcome results
None listed