Diseases of the lips
Conditions
Interventions
The unit of analysis will be each lower lip (n = 60). After agreeing and signing the Free and Informed Consent Form (ICF), patients will be randomized and divided into two groups each with 30 patients
Sponsors
UNESP - Universidade Estadual Paulista
UNESP - Universidade Estadual Paulista
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Sign the Informed Consent Form; age over 18 years of both sexes; present histological diagnosis of QA in the lower lip.
Exclusion criteria
Exclusion criteria: Phototypes V and VI; selected treatment area that has atypical clinical appearance or other dermatoses; current and 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 current or previous diagnosis of CPB on the lower lip; present hypersensitivity or allergy to any of the substances under study; any treatment for QA in the last 8 weeks except photoprotection; suspected or confirmed pregnancy; women of childbearing potential who do not use contraception; women who are breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find a complete clearance rate of QAs at D60 verified by histopathological analysis and we will observe a variation of at least 15% in the measurements between the treatment groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the clinical improvement of the lower lip by comparing D0 with D60 by checking clinical evaluation by photographs and dermoscopic evaluation.;Evaluate epithelial dysplasia using the KIN evaluation method by comparing D0 with D60, observing the histological improvement.;Evaluate adverse effects related to the proposed treatments, incidence of local events and severity by actively asking for possible effects (bleeding, pain, burning, numbness, discomfort in eating, hypertrophic scars after the procedure).;Assess tolerability through subjective preference to any of the proposed treatments. | — |
Countries
Brazil
Contacts
Public ContactLuiz Garbers
Outcome results
None listed