Actinic keratosis
Conditions
Interventions
63 participants will be treated. The right and left sides of the face or scalp of the same participant will be randomized to receive the treatments: 1-treatment with Methyl ALA and Red Light close to
Procedure/surgery
E02.186.500
Sponsors
Universidade Julio Mesquita Filho
Fundação Hospital Amaral Carvalho
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Sign the free and informed consent form (TCLE - Annex1);Age over 50, of both sexes; Holders of at least 3 bilateral QAs with clinical similarities between hemifaces / hairy hairs; No treatments in the last 3 months.
Exclusion criteria
Exclusion criteria: Women of gestational age not using contraceptives; History of skin photosensitization; Hypersensitivity to porphyrins; Photodermose; Any associated immunosuppressive conditions (eg, HIV, systemic disease, use of corticosteroids, kidney transplant recipients). Note: patients with multiple QA criteria on the face and simultaneously on the scalp, will only be included in the most compromised region.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Presentation of the method used to verify the outcome of the pain through the application of a numerical visual scale during treatment with photodynamic therapy to calculate the average pain reported by the patients. ;Considering that the frequency of moderate and severe pain with PDT for face and scalp QA treatment was 54.0% to 64.9%. According to Kasche et al., Assuming that treatment with ALA-PDT with a distance of 5cm this frequency will be 30% smaller, there will be a need for 63 treated sides with each treatment, with beta power of 0.8 and alpha of 0.05. (OVERALL, 1994). | — |
Secondary
| Measure | Time frame |
|---|---|
| To verify the expected outcome by presenting the parameters: Complete bleaching rate by counting the QA before the treatment with the two interventions (T0) and after 60 days of the treatments (T60); by means of the optical analysis of the skin of three-dimensional shape using the 3D camera. Comparison of patients' preference between treatments 1 and 2 at the end of treatments and at T60.;Os desfechos serão analisados a partir de um modelo multinível para variáveis dependentes (modelo linear generalizado de efeitos mistos), com matriz de covariância autoregressiva (AR1) e ajuste de probabilidade para a distribuição mais adequada (ex. gama ou binominal negativa). | — |
Countries
Brazil
Contacts
Public ContactElisângela ;Luciana Oliveira;Abbade
Fundação Hospital Amaral Carvalho;Universidade Julio Mesquita Filho
Outcome results
None listed