Cheilitis
Conditions
Interventions
Patients will be randomly assigned to two groups. For the randomization, the Research Randomizer platform will be used, available through the website: www.randomizer.org
Fludroxycortide Group: 20 part
Imiquimod Cream Therapy Group: 20 participants treated by topical application of Imiquimod cream. Fludroxycortide will be used in the form of a cream, at a concentration of 0.125 mg/g, three times a d
Sponsors
Fernanda Gonçalves Salum
Pontifícia Universidade Católica do Rio Grande do Sul
Eligibility
Age
30 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with actinic cheilosis classified as grades III or IV as previously described; Over the age of 30 years; White skinned
Exclusion criteria
Exclusion criteria: The presence of other lesions in lip vermilion in addition to solar cheilitis; Immunosuppression such as transplanted or infected with HIV patients; Any type of treatment for actinic cheilosis in the last six months (except with sunscreen and lip balms; Known allergy to imiquimod or fludroxycortide; Pregnancy or breastfeeding; Histopathological diagnosis of carcinoma in situ or invasive squamous cell carcinoma; History of radiotherapy in the head and neck region; Any condition that may compromise the collaboration in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in clinical grade of the disease (Grade I, Grade II, Grade III and Grade IV) at the end of treatment, 60 and 180 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference between the Imiquimod and Fludroxycortide groups in terms of participant satisfaction and tolerability.;Difference between Imiquimod and Fludroxycortide groups regarding adverse effects. | — |
Countries
Brazil
Contacts
Public ContactFernanda Salum
Pontifícia Universidade Católica do Rio Grande do Sul
Outcome results
None listed