An Assessment of the Efficacy and Safety of Employing a Duosomal Chemical Peel for Aesthetic Enhancement in the Periocular and Facial Regions
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Objective skin quality improvement
研究概览
简要总结
This study will employ an experimental, prospective, longitudinal, and comparative before-and-after design. The objective is to assess the efficacy and safety of duosomal chemical peels as agents for enhancing the aesthetic appearance of the periocular and facial regions
详细描述
Participants aged over 21 years will be included in the study. They will receive an application of salicylic acid to the facial surface through continuous massaging for a duration of five minutes, facilitating the exfoliation of the superficial epidermal layers. Subsequently, a specific medication will be administered based on the skin characteristics and the intended treatment objective: salicylic acid for individuals predisposed to oily skin and acne, mandelic acid for those with irregular pigmentation and hyperpigmentation, lactic acid for individuals with sensitive skin, and glycolic acid for those with wrinkles and pigmentation changes due to aging. A moisturizer will then be applied and massaged continuously, allowing it to act for five minutes. These treatments will be administered weekly over a four-week period. Improvement as reported by the study participants will be evaluated using the Face-Q and SASSQ (Scientific Assessment Scale of Skin Quality) questionnaires. The SASSQ is an objective scale completed by the researcher, assessing loss of elasticity, wrinkles, roughness, pigmentation, erythema, and pore size on a scale from 0 to 4, where 0 denotes absence of the parameter and 4 indicates very severe changes. The FACE-Q is a subjective scale completed by the participants, ranging from 1 to 4, where 1 signifies very dissatisfied and 4 signifies very satisfied. Descriptive statistics of the demographic variables will be conducted, and analytical statistics using the Wilcoxon test will be employed to compare baseline and final results at the conclusion of the treatment. A p-value of less than 0.05 will be considered statistically significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged 21 years and older, both male and female, who seek enhancement of the periocular and facial regions will be considered for recruitment. Participants must agree to the study conditions, consent to the follow-up period as proposed, and provide informed consent for the procedure.
排除标准
- •Individuals with psychiatric disorders, those exhibiting symptoms indicative of body dysmorphia, and those who have undergone facial filler treatments within the six months preceding the procedure. Elimination criteria: Participants who fail to adhere to follow-up protocols during the designated periods; those who receive additional treatments such as mesotherapy, botulinum toxin, chemical peeling, or facial fillers in the same area during the follow-up period; and those who, during the follow-up period, develop any debilitating illness or conditions resulting in a wasting/emaciation syndrome.
研究组 & 干预措施
Participants aged over 21 years included in the study
They will receive an application of salicylic acid to the facial surface through continuous massaging for a duration of five minutes, facilitating the exfoliation of the superficial epidermal layers. Subsequently, a specific medication will be administered based on the skin characteristics and the intended treatment objective: salicylic acid for individuals predisposed to oily skin and acne, mandelic acid for those with irregular pigmentation and hyperpigmentation, lactic acid for individuals with sensitive skin, and glycolic acid for those with wrinkles and pigmentation changes due to aging. A moisturizer will then be applied and massaged continuously, allowing it to act for five minutes. These treatments will be administered weekly over a four-week period
干预措施: Duosomal chemical peel application (Drug)
结局指标
主要结局
Objective skin quality improvement
时间窗: From enrollment to the end of treatment at 4 weeks
The SASSQ (Scientific Assessment Scale of Skin Quality) is an objective scale completed by the researcher, assessing loss of elasticity, wrinkles, roughness, pigmentation, erythema, and pore size on a scale from 0 to 4, where 0 denotes absence of the parameter and 4 indicates very severe changes
Subjective skin quality improvement
时间窗: From enrollment to the end of treatment at 4 weeks
The FACE-Q is a subjective scale completed by the participants, ranging from 1 to 4, where 1 signifies very dissatisfied and 4 signifies very satisfied
次要结局
未报告次要终点
