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临床试验/NCT07401342
NCT07401342已完成4 期

An Assessment of the Efficacy and Safety of Employing a Duosomal Chemical Peel for Aesthetic Enhancement in the Periocular and Facial Regions

Instituto de Oftalmología Fundación Conde de Valenciana1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2023年11月1日最近更新:
干预措施

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

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

Experimental

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

研究者

发起方
Instituto de Oftalmología Fundación Conde de Valenciana
申办方类型
Other
责任方
Sponsor

研究点 (1)

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