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临床试验/NCT04998578
NCT04998578招募中不适用

Comparison Of Aesthetic Techniques For Rejuvenation Of Genital Region: A Randomized Clinical Trial

Centro de Atenção ao Assoalho Pélvico3 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2021年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
112
试验地点
3
主要终点
Genital Hyperchromia

研究概览

简要总结

The microneedle is a minimally invasive technique, consists of the application of a roller surrounded by small and thin needles that pierce the skin and generate a mechanical stimulus with no ablative effect on the skin. The study aims to test the hypothesis that the technique of microneedle in the treatment of tissue flaccidity and hyperchromia of female external genitalia is safe and with a more effective result in clinical improvement through genital rejuvenation and unification of skin tone when compared to non-ablative radiofrequency technique.

详细描述

Dissatisfaction with the genital image has been receiving more attention in recent years and is influenced by mediation and the methods of waxing modernity. In the face of this, the number of women in search for aesthetic female genital surgeries. Since the year 2015, the implementation of the Labiaplasty surgery had a growth of 45% worldwide. Brazil is a leader in the procedure, with a total of 23,155 procedures in the year 2016 (ISAPS DATA). However, the Most genital surgical cases are performed unnecessarily, without long-term term, according to a conflict of interest arising from financial gain, generating ethical complications The search for aesthetic non-invasive genital treatments, in its majority, is related to sagging big lips and genital hyperchromia. In the literature, the non-invasive therapeutic resource and with fewer adverse effects described for aesthetics of the genital region is the use of the radiofrequency apparatus ablative, considered to be a safe and effective technique for flaccidity of the cutaneous tissue. It is not described in the literature treatments used for genital hyperchromia, however, several formulations for clearings using Kojic acid and Niacinamide, already described as effective for other regions, are available for marketing primarily for genital year whitening.

Minimally invasive technique, consists of the application of a roller surrounded by small and thin needles that pierce the skin and generate a mechanical stimulus with no ablative effect on the skin.

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
Single (Investigator)

盲法说明

the data of the participants will be collected by evaluators blind to the study and who will not know the allocation of the patients

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women aged 18-65 years with skin flaccidity and genital hyperchromia

排除标准

  • Patients who use cosmetics in the genital region
  • Use of anticoagulant medication
  • Use of pacemakers
  • Pregnancy
  • Dermatoses in the region to be treated and / or local inflammatory condition, without diagnosis of infection
  • Difficulty in understanding the proposed instruments

结局指标

主要结局

Genital Hyperchromia

时间窗: 1, 3, 6 and 12 months after treatment

It will be evaluated the uniformity of the skin tone, evidenced by the self report, comparison of images taken before after the procedure and satisfaction of the participant, verified in the scale of Likert and Scale Visual Analog.

External genital Laxity

时间窗: 1, 3, 6 and 12 months after treatment

It will be evaluated by turgor, number of skinfolds, evidenced by self report, comparison of images taken before and after the procedure and satisfaction of the patient, verified in the Likert scale and Visual Analog Scale.

次要结局

  • Melasma Quality of Life(1, 3, 6 and 12 months after treatment)
  • Sexual function(1, 3, 6 and 12 months after treatment)
  • Female Genital Self-Image(1, 3, 6 and 12 months after treatment)

研究者

发起方
Centro de Atenção ao Assoalho Pélvico
申办方类型
Other
责任方
Sponsor

研究点 (3)

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