Actinic cheilitis (AC) is a potentially malignant disorders of the oral mucosa (PMD) that occurs on the lip dua to excessive and cronic exposure to ultraviolet rays present in sunlight. This condition can progress to squamous cell carcinoma and the clinical characteristics of AC include atrophy of the vermilion border of the lip
Conditions
Interventions
Experimental group: 15 patients with actinic cheilitis will receive a phytotherapy formulation with mucoadhesive properties (20mg/ml ofCurcuma longa L. and 40% of glycerinated extract of Bidens pilosa
Drug
E02.190.755
Sponsors
Faculdade de Odontologia - Universidade Federal de Goiás
Faculdade de Odontologia - Universidade Federal de Goiás
Eligibility
Inclusion criteria
Inclusion criteria: Patients with actinic cheilitis lesions who can cooperate and who agreed to participate in the study signed the free informed consent form
Exclusion criteria
Exclusion criteria: Patients who don´t agreed to participate in the study signed the free informed consent form; allergic to any component of the formulation; immunocompromised patients and those exhibiting ulcerated areas, nodularity, and bleeding in the lip that could suggest progression of SCC; and patients using medications in the target area
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is hoped to find improvement of the clinical signs of actinic cheilitis in the patients of the experimental group who make use of the phytotherapic. This will be verified from a photographic evaluation of the lips before and after treatment, which will receive scores according to their clinical aspect: 1 - complete improvement; 2 - partial improvement; 3 - no change; 4 - worsening of the clinical condition | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the patient's tolerability to the drug and its satisfaction after treatment. It will be evaluated with questionnaire adapted from the study of Nelson, Spencer, and Nelson, applied at the end of treatment using a 5-point scale of responses, where 0 = I neither agree nor disagree; 1 = I slightly agree; 2 = I completely agree; 3 = I slightly disagree; and 4 = I completely disagree, to the following statements: (a) My lip lesions have improved with this product; (b) This product does not cause irritation to the lips; (c) I am satisfied with this product | — |
Countries
Brazil
Contacts
Public ContactAna;Nádia Serafim Vilela;do Lago Costa
Faculdade de Odontologia - Universidade Federal de Goiás;Faculdade de Odontologia - Universidade Federal de Goiás
Outcome results
None listed