actinic keratosis
Conditions
Interventions
Included patients will be randomized to receive FPS 99 sunscreen treatment containing photoliase, to be used twice daily with topical application to both forearms and back of hands
or sunscreen with SPF 99, also to be used twice a day on both forearms and back of hands. Each group will consist of 20 patients (20 in the sunscreen group with photolysis and 20 in the sunscreen grou
Drug
Sponsors
Faculdade de Medicina de Botucatu - UNESP
Faculdade de Medicina de Botucatu - UNESP
Eligibility
Age
50 Years to 90 Years
Inclusion criteria
Inclusion criteria: Sign the Informed Consent Form; Age between 50 and 90 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: Fewer than three or more than ten injuries in each forearm; Selected treatment area that has atypical clinical appearance or other extensive forearm dermatoses; 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; Have hypersensitivity or allergy to any of the subtances under study; Patients using any systemic or topical immunosuppressive substance, oral retinoid, and other local treatments (eg corticosteroids, anti-inflammatory drugs, retinoids); Immunocompromised individuals; Coagulation disorders; Suspected or confirmed pregnancy. Note: Women of childbearing age should receive urinary Beta HCG at the beginning of treatment to exclude incipient pregnancy; Women of childbearing age who do not use contraception; Breastfeeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find a 100% reduction in the number of actinic forearm keratoses from individual skin lesion counts at the pre-treatment interval and after 8 weeks of treatment.;At least 50% improvement in the absolute score of the forearm photoaging scale is expected to be seen in the pre-treatment interval and after 8 weeks of treatment. The photoaging scale of the forearms will be completed at both times according to the parameters contained in it (number of superficial actinic keratoses, number of hypertrophic actinic keratoses, presence of wrinkles, presence of visible purpura, presence of atrophic scars, presence of elastosis) and the findings of the participant's forearm clinical examination | — |
Secondary
| Measure | Time frame |
|---|---|
| A reduction of 50% or more in the number of actinic forearm keratoses is expected from the individual skin lesion count, pre-treatment interval and after 8 weeks of treatment.;We will evaluate the presence of adverse effects related to the proposed treatments, from the participant's questioning about the presence of symptoms such as burning, redness, peeling, blistering or local pain, after completing the use of the proposed treatments within 8 weeks.;We will evaluate the appearance of non-melanoma skin tumors in the studied territory (forearms) from the participant's clinical examination after 8 weeks of treatment.;We will evaluate the tolerability of the treatments, based on the participant's questioning, after 8 weeks of treatment. | — |
Countries
Brazil
Contacts
Public ContactBruno Alvares
Faculdade de Medicina de Botucatu - UNESP
Outcome results
None listed