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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Laxity; Skin, Skin Hyperpigmentation, Needlestick Puncture

Intervention / Treatment
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* Device: Comparison of aesthetic techniques


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Women aged 18-65 years with skin flaccidity and genital hyperchromia Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group A will only perform microneedling; group B will perform microneedling associated with the use of cosmetic in the office; group C will perform microneedling associated with the cosmetology of office and home use; and group D will perform non-ablative radiofrequency. Due to the application characteristics of the microneedle technique, there is no way to use a placebo group.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Microneedling- Group A<br>Participants will only perform microneedling | Device: Comparison of aesthetic techniques<br>* Comparison of aesthetic techniques for rejuvenation and glazing of the genital region<br>|
| Active Comparator: Microneedling and outpatient Cosmetics- Group B<br>Microneedling associated with the use of outpatient cosmetics | Device: Comparison of aesthetic techniques<br>* Comparison of aesthetic techniques for rejuvenation and glazing of the genital region<br>|
| Active Comparator: microneedling and home use cosmetics - Group C<br>Microneedling associated with home use cosmetics | Device: Comparison of aesthetic techniques<br>* Comparison of aesthetic techniques for rejuvenation and glazing of the genital region<br>|
| Active Comparator: Non-ablative radiofrequency - Group D<br>Participants will perform only non-ablative radiofrequency | Device: Comparison of aesthetic techniques<br>* Comparison of aesthetic techniques for rejuvenation and glazing of the genital region<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| External genital Laxity | 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. | 1, 3, 6 and 12 months after treatment | 
| Genital Hyperchromia | 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. | 1, 3, 6 and 12 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual function | It will be evaluated through the questionnaire Sexual Quotient - Female Version (QS-F), Female Sexual Function Index (FSFI) | 1, 3, 6 and 12 months after treatment | 
| Female Genital Self-Image | It will be evaluated through the Female Genital Self-Image Scale (FGSIS) > 26 | 1, 3, 6 and 12 months after treatment | 
| Melasma Quality of Life | It will be evaluated through the Melasma Quality of Life Scale (MELASQoL). | 1, 3, 6 and 12 months after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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microneedling, laxity, Skin Hyperpigmentation