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

December 4, 2023 updated by: Centro de Atenção ao Assoalho Pélvico
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • Ba
      • Salvador, Ba, Brazil, 40.290-000
        • Recruiting
        • Centro de Atenção ao Assoalho Pélvico
        • Contact:
    • Bahia
      • Salvador, Bahia, Brazil, 40290000
        • Recruiting
        • Centro de Atenção ao Assoalho Pélvico
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sexual function
Time Frame: 1, 3, 6 and 12 months after treatment
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
Time Frame: 1, 3, 6 and 12 months after treatment
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
Time Frame: 1, 3, 6 and 12 months after treatment
It will be evaluated through the Melasma Quality of Life Scale (MELASQoL).
1, 3, 6 and 12 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro de Atenção ao Assoalho Pélvico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

June 26, 2019

First Submitted That Met QC Criteria

August 3, 2021

First Posted (Actual)

August 10, 2021

Study Record Updates

Last Update Posted (Estimated)

December 11, 2023

Last Update Submitted That Met QC Criteria

December 4, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Caap

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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