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Clinical Trial 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.


Clinical Trial Description

Three formulations are used in this research: imiquimod 5%, imiquimod 0.05% e imiquimod nanoencapsulated 0.05%. Nanoencapsulation is a process that concentrates the drug into a capsule not visible to the naked eye, allowing it to penetrate skin more easily and will only release the drug at the lesion site. The drug is presented in a free form inside the gel in the others formulations. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04219358
Study type Interventional
Source Hospital de Clinicas de Porto Alegre
Contact
Status Terminated
Phase Phase 1
Start date March 23, 2019
Completion date August 24, 2021

See also
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Completed NCT00849992 - Treatment Study for Actinic Cheilitis Comparing Imiquimod 5% and Photodynamic Therapy Phase 4
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Recruiting NCT04744103 - Trichloroacetic Acid as a Topical Treatment for Actinic Cheilitis Phase 4
Completed NCT00868088 - Photodynamic Therapy to Treat Actinic Damage in Patients With Squamous Cell Carcinoma (SCC) of the Lip Phase 4
Completed NCT02198469 - Study of Methyl Aminolaevulinate Photodynamic Therapy With and Without Er:YAG Laser in Actinic Cheilitis Phase 1
Withdrawn NCT03452566 - Evaluation of Ingenol Mebutate for Actinic Cheilitis Treatment Phase 1/Phase 2
Completed NCT02409732 - Photodynamic Therapy (PDT) With Levulan and Blue Light for the Treatment of Actinic Cheilitis Phase 4