Topical Application of Imiquimod Gel at Different Concentrations in Actinic Cheilitis

Hospital de Clinicas de Porto Alegre

Status and phase: Terminated; Phase 1

Conditions: Actinic Cheilitis

Treatments: Drug: Imiquimod nanoencapsulated 0,05% gel; Drug: Vehicle Gel Base; Drug: Imiquimod 0,05% gel; Drug: Imiquimod 5% gel; Drug: Dexpanthenol; Drug: Lip sunscreen 30 Sun Protector Factor (SPF)

Study type: Interventional

Funder types: Other

Identifiers

NCT04219358

2018-0656

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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49 participants in 4 patient groups

Placebo & Standard Treatment

Active Comparator group

Treatment:

Drug: Lip sunscreen 30 Sun Protector Factor (SPF)

Drug: Dexpanthenol

Drug: Vehicle Gel Base

Imiquimod 5% & Standard Treatment

Experimental group

Treatment:

Drug: Lip sunscreen 30 Sun Protector Factor (SPF)

Drug: Dexpanthenol

Drug: Imiquimod 5% gel

Imiquimod 0.05% & Standard Treatment

Experimental group

Treatment:

Drug: Lip sunscreen 30 Sun Protector Factor (SPF)

Drug: Imiquimod 0,05% gel

Drug: Dexpanthenol

Imiquimod nanoencapsulated 0.05% & Standard Treatment

Experimental group

Treatment:

Drug: Lip sunscreen 30 Sun Protector Factor (SPF)

Drug: Dexpanthenol

Drug: Imiquimod nanoencapsulated 0,05% gel