Topical Application of Imiquimod Gel at Different Concentrations in Actinic Cheilitis

  • STATUS
    Recruiting
  • participants needed
    172
  • sponsor
    Hospital de Clinicas de Porto Alegre
Send
Updated on 16 February 2024
See if I qualify

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.

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.

Details
Condition Actinic Cheilitis
Age 18years - 85years
Treatment Vehicle Gel Base, Imiquimod 5% gel, Imiquimod 0,05% gel, Imiquimod nanoencapsulated 0,05% gel, Lip sunscreen 30 Sun Protector Factor (SPF), Dexpanthenol
Clinical Study IdentifierNCT04219358
SponsorHospital de Clinicas de Porto Alegre
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.