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

NCT04998578 | Unknown DMC

• 1 other identifier: Caap
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 2

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.

Conditions

Laxity; Skin; Skin Hyperpigmentation; Needlestick Puncture

Keywords

microneedling; laxity; Skin Hyperpigmentation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Sexual function

  1, 3, 6 and 12 months after treatment

• Female Genital Self-Image

  1, 3, 6 and 12 months after treatment

• Melasma Quality of Life

  1, 3, 6 and 12 months after treatment

Study Arms (4)

Microneedling- Group A

ACTIVE COMPARATOR

Participants will only perform microneedling

Device: Comparison of aesthetic techniques

Microneedling and outpatient Cosmetics- Group B

ACTIVE COMPARATOR

Microneedling associated with the use of outpatient cosmetics

Device: Comparison of aesthetic techniques

microneedling and home use cosmetics - Group C

ACTIVE COMPARATOR

Microneedling associated with home use cosmetics

Device: Comparison of aesthetic techniques

Non-ablative radiofrequency - Group D

ACTIVE COMPARATOR

Participants will perform only non-ablative radiofrequency

Device: Comparison of aesthetic techniques

Interventions

Comparison of aesthetic techniques DEVICE

Comparison of aesthetic techniques for rejuvenation and glazing of the genital region

Microneedling and outpatient Cosmetics- Group B; Microneedling- Group A; Non-ablative radiofrequency - Group D; microneedling and home use cosmetics - Group C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centro de Atenção ao Assoalho Pélvico: lead

Study Sites (2)

Centro de Atenção ao Assoalho Pelvico

Salvador, Estado de Bahia, 40.290-000, Brazil

RECRUITING

Centro de Atenção ao assoalho pélvico

Salvador, Estado de Bahia, 40290000, Brazil

RECRUITING

Related Publications (18)

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• Portman DJ, Gass ML; Vulvovaginal Atrophy Terminology Consensus Conference Panel. Genitourinary syndrome of menopause: new terminology for vulvovaginal atrophy from the International Society for the Study of Women's Sexual Health and the North American Menopause Society. Menopause. 2014 Oct;21(10):1063-8. doi: 10.1097/GME.0000000000000329.

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• Lapii GA, Yakovleva AY, Neimark AI. Structural Reorganization of the Vaginal Mucosa in Stress Urinary Incontinence under Conditions of Er:YAG Laser Treatment. Bull Exp Biol Med. 2017 Feb;162(4):510-514. doi: 10.1007/s10517-017-3650-0. Epub 2017 Feb 27.

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  PMID: 7731384 BACKGROUND

• Flores SA, Hall CA. Atrophic Vaginitis(Archived). 2025 Jun 19. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK564341/

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• Herbenick D, Reece M. Development and validation of the female genital self-image scale. J Sex Med. 2010 May;7(5):1822-30. doi: 10.1111/j.1743-6109.2010.01728.x. Epub 2010 Mar 3.

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MeSH Terms

Conditions

Cutis Laxa; Hyperpigmentation

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Pigmentation Disorders

Central Study Contacts

Patrícia Lordelo

CONTACT

(71) 8859-2400/3330-1640; pvslordelo@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: the data of the participants will be collected by evaluators blind to the study and who will not know the allocation of the patients
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: August 10, 2021
• Study Start: October 1, 2021
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: December 11, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)