NCT04219358

Topical Application of Imiquimod Gel at Different Concentrations in Actinic Cheilitis

Evaluation of Topical Application of 5% Imiquimod, 0.05% Imiquimod and 0.05% Nanoencapsulated Imiquimod Gel in the Treatment of Actinic Cheilitis: a Randomized Controlled Trial

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Hospital de Clinicas de Porto Alegre · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Actinic Cheilitis

Interventions

Type	Name	Description
DRUG	Vehicle Gel Base	Apply 0.5ml of gel stored in a 1ml syringe over the lip 3 times a week (Mondays, Wednesdays and Fridays) at night for a period of 4 weeks. Gel components: medium molecular weight chitosan, lactic acid 85% and water.
DRUG	Imiquimod 5% gel	Apply 0.5ml of gel stored in a 1ml syringe over the lip 3 times a week (Mondays, Wednesdays and Fridays) at night for a period of 4 weeks. Gel components: medium molecular weight chitosan, lactic acid 85% and free form imiquimod 5%.
DRUG	Imiquimod 0,05% gel	Apply 0.5ml of gel stored in a 1ml syringe over the lip 3 times a week (Mondays, Wednesdays and Fridays) at night for a period of 4 weeks. Gel components: medium molecular weight chitosan, lactic acid 85% and imiquimod 0.05% free form.
DRUG	Imiquimod nanoencapsulated 0,05% gel	Apply 0.5ml of gel stored in a 1ml syringe over the lip 3 times a week (Mondays, Wednesdays and Fridays) at night for a period of 4 weeks. Gel components: medium molecular weight chitosan, lactic acid 85% and imiquomod in a nanoencapsulated suspension at concentration of 0,05%
DRUG	Lip sunscreen 30 Sun Protector Factor (SPF)	Apply sunscreen on the lip 30 minutes every day before sun exposure. Protects against both UVA (ultraviolet A) and UVB (ultraviolet B rays).
DRUG	Dexpanthenol	Apply dexpanthenol on the lip, two (2) times a day, once in the morning and once in the afternoon. Reduces transepidermic water loss and maintaining the natural smoothness and elasticity of the skin. It accelerates the cell renewal, rebuilds damaged tissues and promote the normal keratinisation of the skin and hair.

Timeline

• Start date: 2019-03-23
• Primary completion: 2020-06-24
• Completion: 2021-08-24
• First posted: 2020-01-07
• Last updated: 2022-11-22

Locations

2 sites across 1 country: Brazil