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

Primary Purpose

Laxity; Skin, Skin Hyperpigmentation, Needlestick Puncture

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Comparison of aesthetic techniques
Sponsored by
Centro de Atenção ao Assoalho Pélvico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Laxity; Skin focused on measuring microneedling, laxity, Skin Hyperpigmentation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Centro de Atenção ao assoalho pélvicoRecruiting
  • Centro de Atenção ao Assoalho PelvicoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Microneedling- Group A

Microneedling and outpatient Cosmetics- Group B

microneedling and home use cosmetics - Group C

Non-ablative radiofrequency - Group D

Arm Description

Participants will only perform microneedling

Microneedling associated with the use of outpatient cosmetics

Microneedling associated with home use cosmetics

Participants will perform only non-ablative radiofrequency

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Sexual function
It will be evaluated through the questionnaire Sexual Quotient - Female Version (QS-F), Female Sexual Function Index (FSFI)
Female Genital Self-Image
It will be evaluated through the Female Genital Self-Image Scale (FGSIS) > 26
Melasma Quality of Life
It will be evaluated through the Melasma Quality of Life Scale (MELASQoL).

Full Information

First Posted
June 26, 2019
Last Updated
June 21, 2023
Sponsor
Centro de Atenção ao Assoalho Pélvico
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1. Study Identification

Unique Protocol Identification Number
NCT04998578
Brief Title
Comparison Of Aesthetic Techniques For Rejuvenation Of Genital Region: A Randomized Clinical Trial
Official Title
Comparison Of Aesthetic Techniques For Rejuvenation Of Genital Region: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centro de Atenção ao Assoalho Pélvico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laxity; Skin, Skin Hyperpigmentation, Needlestick Puncture
Keywords
microneedling, laxity, Skin Hyperpigmentation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Investigator
Masking Description
the data of the participants will be collected by evaluators blind to the study and who will not know the allocation of the patients
Allocation
Randomized
Enrollment
112 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Microneedling- Group A
Arm Type
Active Comparator
Arm Description
Participants will only perform microneedling
Arm Title
Microneedling and outpatient Cosmetics- Group B
Arm Type
Active Comparator
Arm Description
Microneedling associated with the use of outpatient cosmetics
Arm Title
microneedling and home use cosmetics - Group C
Arm Type
Active Comparator
Arm Description
Microneedling associated with home use cosmetics
Arm Title
Non-ablative radiofrequency - Group D
Arm Type
Active Comparator
Arm Description
Participants will perform only non-ablative radiofrequency
Intervention Type
Device
Intervention Name(s)
Comparison of aesthetic techniques
Intervention Description
Comparison of aesthetic techniques for rejuvenation and glazing of the genital region
Primary Outcome Measure Information:
Title
External genital Laxity
Description
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.
Time Frame
1, 3, 6 and 12 months after treatment
Title
Genital Hyperchromia
Description
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.
Time Frame
1, 3, 6 and 12 months after treatment
Secondary Outcome Measure Information:
Title
Sexual function
Description
It will be evaluated through the questionnaire Sexual Quotient - Female Version (QS-F), Female Sexual Function Index (FSFI)
Time Frame
1, 3, 6 and 12 months after treatment
Title
Female Genital Self-Image
Description
It will be evaluated through the Female Genital Self-Image Scale (FGSIS) > 26
Time Frame
1, 3, 6 and 12 months after treatment
Title
Melasma Quality of Life
Description
It will be evaluated through the Melasma Quality of Life Scale (MELASQoL).
Time Frame
1, 3, 6 and 12 months after treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrícia Lordelo
Phone
(71) 8859-2400/3330-1640
Email
pvslordelo@hotmail.com
Facility Information:
Facility Name
Centro de Atenção ao assoalho pélvico
City
Salvador
State/Province
Bahia
ZIP/Postal Code
40290000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Lordelo, post doc
Phone
+5571988592400
Email
pvslordelo@hotmail.com
Facility Name
Centro de Atenção ao Assoalho Pelvico
City
Salvador
State/Province
Ba
ZIP/Postal Code
40.290-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia V Lordelo, Phd
Phone
+5571988592400
Email
pvslordelo@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
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Comparison Of Aesthetic Techniques For Rejuvenation Of Genital Region: A Randomized Clinical Trial

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