TerminatedPhase 1

Topical Application of Imiquimod Gel at Different Concentrations in Actinic Cheilitis

Stopped: Study terminated because of COVID19 pandemics.

Brazil49 participantsStarted 2019-03-23

Plain-language summary

Actinic cheilitis is a potentially malignant lesion on the lower lip, which can progress to more serious illnesses such as cancer if not treated. Usually treatment of this condition is only based on clinical appearance, but there is no established cure treatment. Topical imiquimod is a medicine indicated for the treatment of skin diseases, but it has not yet been proven to treat actinic cheilitis. In this research, the investigator's aim is to evaluate the response to actinic cheilitis treatment with the current standard treatment compared to high and low concentration imiquimod topical formulations.

Who can participate

Age range18 Years – 85 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Individuals with clinical and histopathological diagnosis of actinic cheilitis; * No previous lip treatment with Imiquimod. Exclusion Criteria: * Present lesions suspected of squamous cell carcinoma of the lip. * Previous history of lip cancer treatment. * Prior treatment other than standard treatment. * History of allergic reactions to imiquimod or any other component of the formulas.

What they're measuring

Clinical Response

Timeframe: 30 days after conclusion of treatment

Clinical Response

Timeframe: 180 days after conclusion of treatment

Trial details

NCT IDNCT04219358

SponsorHospital de Clinicas de Porto Alegre

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-06-24

View on ClinicalTrials.gov More Actinic Cheilitis trials