Actinic keratosis Skin field Cancerization Squamous cell Carcinoma
Conditions
Interventions
divided into two groups: one group will receive Polypodium leucotomus 500mg tablets to be administered every 12 hours for 60 days, and the second equivalent to hydrocellulose tablets (placebo). Patien
or mebutate 0.05% gel, administered once daily for 2 days in the proximal half of the forearm and subsequently in the distal half of the same forearm, with the same dosage
or sunscreen application, without any additional topical treatment. For each patient, the study will last 180 days. During this time, participants will be instructed to use broad spectrum sunscreen (U
Drug
B01.650.940.800.575.912.063.700.666
Sponsors
Faculdade de Medicina - Unesp Botucatu
Faculdade de Medicina - Unesp Botucatu
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Sign the Term of Free and Informed Consent; • Age above 18 years of both sexes; • Present at least three and at most ten lesions clinically compatible with actinic keratosis in each forearm, bilaterally.
Exclusion criteria
Exclusion criteria: Injuries less than three or greater than ten in each forearm; Selected treatment area that has atypical clinical appearance or other extensive dermatoses on the forearms; Current and prior 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; To show hypersensitivity or allergy to any of the studied sub-substances; Patients on any systemic or topical immunosuppressive substance, oral retinoid, in addition to other local treatments (eg corticosteroids, anti-inflammatories, retinoids); Immunocompromised individuals; Coagulation disorders; Suspected or confirmed pregnancy; Women of childbearing potential who do not use contraceptive methods; Women in the breastfeeding phase.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete clearance rate of the actinic keratoses in the T60, with reduction difference of more than 10% between the groups, done through clinical counts of the AAS, before the beginning and 60 days after the beginning of the treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Partial clearance rate (> 50%) of the QA, made through clinical QA counts, with difference of 10%, before onset and 60 days after initiation of treatment.;Reduction of the clinical classification of ASF: Counting and severity scale, with difference of 10%, through clinical analysis, before and 60 days after starting treatment;Scale of Antiaging forearms reduction through clinical analysis, with difference of 10%, before and 60 days after starting treatment;Improvement of the histological atypia profile (KIN) between treatments through histopathologycal analysis, with difference of 10%, comparing T0 with T60.;Reduction of expression of p53 and Ki67 between treatments, with difference of 10%, through immunohistochemical analysis comparedT0 with T60.;Epithelial thickness improvement through histologycal analysis, with difference of 10%, comparing T0 with T60.;Emergence of non-melanoma skin tumors, with difference of 10%, through clinical analysis (T0 to T180).;Adverse effects related to the proposed treatments: incidence of local events and severity through clinical analysis, with difference of 10%, 15 days after the beggining of the treatment.;Tolerability: subjective preference for any of the treatments, with difference of 10%, after 60 days of treatment | — |
Countries
Brazil
Contacts
Public ContactAnna Miola
Faculdade de Medicina - Unesp Botucatu
Outcome results
None listed