Actinic Cheilitis
Conditions
Keywords
imiquimod, nanoencapsulation
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.
Interventions
DRUGVehicle 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.
DRUGImiquimod 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%.
DRUGImiquimod 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.
DRUGImiquimod 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%
DRUGLip 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).
DRUGDexpanthenol
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
Federal University of Rio Grande do Sul
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
A pharmacist, who will not have contact with the study subjects at any time, will prepare the hydrogels in transparent sealed syringes, which will be numerically coded and two spreadsheets with the codes will be generated and placed in sealed brown envelopes. One envelope will be held by the pharmacist and the other envelope will be placed in a safe place. Participants will not know which medication they received until the end of the experimental phase. The vehicle gel is identical in appearance to those containing imiquimod. If for any reason the information on which treatment has been allocated is required, the external assistant will take all possible measures to ensure that the masking is not broken. The examiners who will perform the treatment and clinical evaluation will be blinded to the experimental group. Primary outcome measure is based on clinical evaluation of lesions by photographs. The images will be coded in order to achieve blindness of outcome assessors.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Response | 30 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
| Measure | Time frame | Description |
|---|---|---|
| General Satisfaction about the medication: Visual Analogue Scale (VAS) | VAS scale will be generated at 14 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. |
| Adverse Events Severity | The adverse events questionnaire is applied in 14 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 28 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. |
| Cell proliferation - mAgNOR | mAgNOR analysis will be performed at 28 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. |
| Cell proliferation - pAgNOR | pAgNOR analysis will be performed at 28 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. |
Countries
Brazil
Outcome results
None listed