Topical Application of Imiquimod Gel at Different Concentrations in Actinic Cheilitis
- Conditions
- Actinic Cheilitis
- Interventions
- Drug: Vehicle Gel BaseDrug: Lip sunscreen 30 Sun Protector Factor (SPF)
- Registration Number
- NCT04219358
- Lead Sponsor
- Hospital de Clinicas de Porto Alegre
- Brief 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 49
- Individuals with clinical and histopathological diagnosis of actinic cheilitis;
- No previous lip treatment with Imiquimod.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Imiquimod nanoencapsulated 0.05% & Standard Treatment Dexpanthenol - Placebo & Standard Treatment Vehicle Gel Base - Placebo & Standard Treatment Lip sunscreen 30 Sun Protector Factor (SPF) - Imiquimod 5% & Standard Treatment Imiquimod 5% gel - Imiquimod 5% & Standard Treatment Lip sunscreen 30 Sun Protector Factor (SPF) - Imiquimod 0.05% & Standard Treatment Imiquimod 0,05% gel - Imiquimod 0.05% & Standard Treatment Lip sunscreen 30 Sun Protector Factor (SPF) - Imiquimod 0.05% & Standard Treatment Dexpanthenol - Imiquimod nanoencapsulated 0.05% & Standard Treatment Imiquimod nanoencapsulated 0,05% gel - Imiquimod nanoencapsulated 0.05% & Standard Treatment Lip sunscreen 30 Sun Protector Factor (SPF) - Placebo & Standard Treatment Dexpanthenol - Imiquimod 5% & Standard Treatment Dexpanthenol -
- Primary Outcome Measures
Name Time Method Clinical Response 180 days after conclusion of treatment Clinical analysis of lip photographs based on a classification. The lesions will be graded as:
AC Grade I. Dryness and desquamation on the vermilion of lips.
AC Grade II. Atrophy on the vermilion's border, presenting soft surfaces and pallid areas with eruptions. Blurred limit between the lip's vermilion border and the skin, or a dark line demarking that limit can be seen. This melanotic line should be different from ephelides or other pigmented lesions.
AC Grade III. Rough and squamous areas on the drier parts of the vermilion and hyperkeratotic areas, especially when they spread to the wet lip's mucosa (border between mucosa and semimucosa).
AC Grade IV. Ulceration present in one or more sites of the lip's vermillion or Leukoplakia, mainly in more traumatic places, due to the history of pipe or cigarettes consumption. These lesions could suggest that a malignization process would be in progress, especially when they are accompanied by endured areas on palpation.
- Secondary Outcome Measures
Name Time Method Cell proliferation - pAgNOR pAgNOR analysis will be performed at 210 days after beginning of the treatment. Upon confirmation of the diagnosis of actinic cheilitis, participants will undergo a noninvasive procedure called exfoliative cytology. The lip mucosa is scraped with cytobrush, which is then used to smear two glass slides. One slide will be stained with AgNOR. With this examination it is possible to analyze cell proliferation activity. A second evaluation parameter will be the percentage of cells with more than 1, 2, 3 and 4 AgNORs / nucleus (pAgNOR). A higher percentage of cells with more than 3 and 4 AgNORs per nucleus indicate greater proliferation.
Adverse Events Severity The adverse events questionnaire is applied in 210 days after beginning of the treatment. Adverse effects will be assessed during clinical evaluation at follow-up and with an adverse effects questionnaire.The questionnaire is based on self-reported events followed by a quantification of severity of local and systemic events. The participants are asked to classify the events in a scale of 0 to 3. 0= no sympton, 1- mild, 2-moderate and 3-severe.
Maturation epithelial pattern Maturation epithelial pattern analysis will be performed at 210 days after beginning of the treatment. Upon confirmation of the diagnosis of actinic cheilitis, participants will undergo a noninvasive procedure called exfoliative cytology. With this examination it is possible to analyze morphological changes of the collected cells by light microscopy. The lip mucosa is scraped with cytobrush, which is then used to smear two glass slides. From one of the obtained smears, Papanicolaou stain will be performed. Papanicoloau staining allows assessing different cell types, which are quantified to evaluate epithelial differentiation.
General Satisfaction about the medication: Visual Analogue Scale (VAS) VAS scale will be generated at 210 days after beginning of the treatment. Satisfaction will be self-reported by VAS scale. The visual analogue scale (VAS) will be used to measure general satisfaction of participants to treatment. Participants will be asked to point in to a white paper with a 10cm line, where 0 represents none satisfaction and 10 maximum satisfaction.
Cell proliferation - mAgNOR mAgNOR analysis will be performed at 210 days after beginning of the treatment. Upon confirmation of the diagnosis of actinic cheilitis, participants will undergo a noninvasive procedure called exfoliative cytology. The lip mucosa is scraped with cytobrush, which is then used to smear two glass slides. One slide will be stained with AgNOR. With this examination it is possible to analyze cell proliferation activity. From the quantification of AgNORs, the average AgNORs / core (mAgNOR) will be calculated. The low average of AgNOR stained cells indicates lower cell proliferation and a higher average indicates greater proliferation.
Trial Locations
- Locations (2)
Hospital de ClÃnicas de Porto Alegre
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
School of Dentistry - Universidade Federal do Rio Grande do Sul
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil