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
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Clinical Response
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals with clinical and histopathological diagnosis of actinic cheilitis;
- •No previous lip treatment with Imiquimod.
排除标准
- •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.
研究组 & 干预措施
Placebo & Standard Treatment
干预措施: Vehicle Gel Base (Drug)
Placebo & Standard Treatment
干预措施: Lip sunscreen 30 Sun Protector Factor (SPF) (Drug)
Placebo & Standard Treatment
干预措施: Dexpanthenol (Drug)
Imiquimod 5% & Standard Treatment
干预措施: Imiquimod 5% gel (Drug)
Imiquimod 5% & Standard Treatment
干预措施: Lip sunscreen 30 Sun Protector Factor (SPF) (Drug)
Imiquimod 5% & Standard Treatment
干预措施: Dexpanthenol (Drug)
Imiquimod 0.05% & Standard Treatment
干预措施: Imiquimod 0,05% gel (Drug)
Imiquimod 0.05% & Standard Treatment
干预措施: Lip sunscreen 30 Sun Protector Factor (SPF) (Drug)
Imiquimod 0.05% & Standard Treatment
干预措施: Dexpanthenol (Drug)
Imiquimod nanoencapsulated 0.05% & Standard Treatment
干预措施: Imiquimod nanoencapsulated 0,05% gel (Drug)
Imiquimod nanoencapsulated 0.05% & Standard Treatment
干预措施: Lip sunscreen 30 Sun Protector Factor (SPF) (Drug)
Imiquimod nanoencapsulated 0.05% & Standard Treatment
干预措施: Dexpanthenol (Drug)
结局指标
主要结局
Clinical Response
时间窗: 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.
次要结局
- Cell proliferation - pAgNOR(pAgNOR analysis will be performed at 210 days after beginning of the treatment.)
- Adverse Events Severity(The adverse events questionnaire is applied in 210 days after beginning of the treatment.)
- Maturation epithelial pattern(Maturation epithelial pattern analysis will be performed at 210 days after beginning of the treatment.)
- General Satisfaction about the medication: Visual Analogue Scale (VAS)(VAS scale will be generated at 210 days after beginning of the treatment.)
- Cell proliferation - mAgNOR(mAgNOR analysis will be performed at 210 days after beginning of the treatment.)