Topical Application of Imiquimod Gel at Different Concentrations in Actinic Cheilitis

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.

Conditions

• Actinic Cheilitis

Interventions

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.

Sponsors & Collaborators

• Federal University of Rio Grande do Sul

  collaborator OTHER

• Hospital de Clinicas de Porto Alegre

  lead OTHER

Principal Investigators

• Fernanda Visioli, PhD · Federal University of Rio Grande do Sul

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-03-23

Primary Completion

2020-06-24

Completion

2021-08-24

Countries

• Brazil

Study Locations