Laxity; SkinNCT04998578
Comparison Of Aesthetic Techniques For Rejuvenation Of Genital Region: A Randomized Clinical Trial
A study testing Comparison of aesthetic techniques in people with Laxity; Skin and Skin Hyperpigmentation, run by Centro de Atenção ao Assoalho Pélvico at 2 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Laxity; Skin, Skin Hyperpigmentation, Needlestick Puncture
- What is being tested?
- Comparison of aesthetic techniques
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 2 sitesBrazil
- Study dates
- 1 Oct 2021to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 18-65 years with skin flaccidity and genital hyperchromia
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites, 2 recruiting
- Recruiting
Centro de Atenção ao Assoalho Pelvico
Salvador, Estado de Bahia, 40.290-000
Patricia V Lordelo, Phd, +5571988592400, pvslordelo@hotmail.com
- Recruiting
Centro de Atenção ao assoalho pélvico
Salvador, Estado de Bahia, 40290000
Patricia Lordelo, post doc, +5571988592400, pvslordelo@hotmail.com
About this study
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.
Read the 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.
- Conditions
- Laxity; Skin, Skin Hyperpigmentation, Needlestick Puncture
- Being tested
- Comparison of aesthetic techniques
- Keywords
- microneedling, laxity, Skin Hyperpigmentation
- Medical subject headings
- Cutis Laxa, Hyperpigmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison of aesthetic techniquesDevice
Comparison of aesthetic techniques for rejuvenation and glazing of the genital region
| Study group | Role | What they receive |
|---|---|---|
| Microneedling- Group A | Active comparator | Participants will only perform microneedling Receives: Device: Comparison of aesthetic techniques |
| Microneedling and outpatient Cosmetics- Group B | Active comparator | Microneedling associated with the use of outpatient cosmetics Receives: Device: Comparison of aesthetic techniques |
| microneedling and home use cosmetics - Group C | Active comparator | Microneedling associated with home use cosmetics Receives: Device: Comparison of aesthetic techniques |
| Non-ablative radiofrequency - Group D | Active comparator | Participants will perform only non-ablative radiofrequency Receives: Device: Comparison of aesthetic techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1, 3, 6 and 12 months after treatment
Secondary outcomes (3)
Sexual function
It will be evaluated through the questionnaire Sexual Quotient - Female Version (QS-F), Female Sexual Function Index (FSFI)
Measured: 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
Measured: 1, 3, 6 and 12 months after treatment
Melasma Quality of Life
It will be evaluated through the Melasma Quality of Life Scale (MELASQoL).
Measured: 1, 3, 6 and 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start1 Oct 2021
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Laxity; SkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Investigator
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro de Atenção ao Assoalho Pélvico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04998578
- Sponsor's protocol ID
- Caap
- Status last verified
- Dec 2023
- First submitted
- 26 Jun 2019
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vieira-Baptista P, Marchitelli C, Haefner HK, Donders G, Perez-Lopez F. Deconstructing the genitourinary syndrome of menopause. Int Urogynecol J. 2017 May;28(5):675-679. doi: 10.1007/s00192-017-3295-6. Epub 2017 Mar 14.
PubMed 28293790Marnach ML, Torgerson RR. Vulvovaginal Issues in Mature Women. Mayo Clin Proc. 2017 Mar;92(3):449-454. doi: 10.1016/j.mayocp.2016.10.031.
PubMed 28259230Filippini M, Del Duca E, Negosanti F, Bonciani D, Negosanti L, Sannino M, Cannarozzo G, Nistico SP. Fractional CO2 Laser: From Skin Rejuvenation to Vulvo-Vaginal Reshaping. Photomed Laser Surg. 2017 Mar;35(3):171-175. doi: 10.1089/pho.2016.4173. Epub 2016 Dec 30.
PubMed 28056209Portman 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.
PubMed 25160739Lapii 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.
PubMed 28243906Ho D, Kraeva E, Wun T, Isseroff RR, Jagdeo J. A single-blind, dose escalation, phase I study of high-fluence light-emitting diode-red light (LED-RL) on human skin: study protocol for a randomized controlled trial. Trials. 2016 Aug 2;17:385. doi: 10.1186/s13063-016-1518-7.
PubMed 27484782Miyata S, Miyaji H, Kawasaki H, Yamamoto M, Nishida E, Takita H, Akasaka T, Ushijima N, Iwanaga T, Sugaya T. Antimicrobial photodynamic activity and cytocompatibility of Au25(Capt)18 clusters photoexcited by blue LED light irradiation. Int J Nanomedicine. 2017 Apr 4;12:2703-2716. doi: 10.2147/IJN.S131602. eCollection 2017.
PubMed 28435253Takada A, Matsushita K, Horioka S, Furuichi Y, Sumi Y. Bactericidal effects of 310 nm ultraviolet light-emitting diode irradiation on oral bacteria. BMC Oral Health. 2017 Jun 6;17(1):96. doi: 10.1186/s12903-017-0382-5.
PubMed 28587675Arunkalaivanan A, Kaur H, Onuma O. Laser therapy as a treatment modality for genitourinary syndrome of menopause: a critical appraisal of evidence. Int Urogynecol J. 2017 May;28(5):681-685. doi: 10.1007/s00192-017-3282-y. Epub 2017 Feb 2.
PubMed 28154914Nilsson K, Risberg B, Heimer G. The vaginal epithelium in the postmenopause--cytology, histology and pH as methods of assessment. Maturitas. 1995 Jan;21(1):51-6. doi: 10.1016/0378-5122(94)00863-3.
PubMed 7731384Flores SA, Hall CA. Atrophic Vaginitis(Archived). 2025 Jun 19. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK564341/
PubMed 33232011Herbenick 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.
PubMed 20233278Cain JM, Iglesia CB, Dickens B, Montgomery O. Body enhancement through female genital cosmetic surgery creates ethical and rights dilemmas. Int J Gynaecol Obstet. 2013 Aug;122(2):169-72. doi: 10.1016/j.ijgo.2013.03.020. Epub 2013 Jun 2.
PubMed 23735570McPencow AM, Guess MK. Giving female genital cosmetic surgery a facelift. Maturitas. 2012 Apr;71(4):313-4. doi: 10.1016/j.maturitas.2012.01.012. Epub 2012 Feb 14. No abstract available.
PubMed 22341089Doddaballapur S. Microneedling with dermaroller. J Cutan Aesthet Surg. 2009 Jul;2(2):110-1. doi: 10.4103/0974-2077.58529.
PubMed 20808602
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Aesthetic Techniques For Rejuvenation Of Genital Region: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04998578
- Acronym / sponsor ID
- Caap
- Conditions
- Laxity; Skin, Skin Hyperpigmentation, Needlestick Puncture
- Keywords
- microneedling, laxity, Skin Hyperpigmentation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Centro de Atenção ao Assoalho PélvicoUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 10 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Microneedling- Group A | Active comparator | Device: Comparison of aesthetic techniquesParticipants will only perform microneedling |
| Microneedling and outpatient Cosmetics- Group B | Active comparator | Device: Comparison of aesthetic techniquesMicroneedling associated with the use of outpatient cosmetics |
| microneedling and home use cosmetics - Group C | Active comparator | Device: Comparison of aesthetic techniquesMicroneedling associated with home use cosmetics |
| Non-ablative radiofrequency - Group D | Active comparator | Device: Comparison of aesthetic techniquesParticipants will perform only non-ablative radiofrequency |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women aged 18-65 years with skin flaccidity and genital hyperchromia
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comparison of aesthetic techniquesComparison of aesthetic techniques for rejuvenation and glazing of the genital region | Device | Microneedling and outpatient Cosmetics- Group B, Microneedling- Group A, Non-ablative radiofrequency - Group D, microneedling and home use cosmetics - Group C |
Primary outcome
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.
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.
3 secondary outcomes
Sexual function
Time frame: 1, 3, 6 and 12 months after treatment
Female Genital Self-Image
Time frame: 1, 3, 6 and 12 months after treatment
Melasma Quality of Life
Time frame: 1, 3, 6 and 12 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Background: PubMed 28293790Vieira-Baptista P, Marchitelli C, Haefner HK, Donders G, Perez-Lopez F. Deconstructing the genitourinary syndrome of menopause. Int Urogynecol J. 2017 May;28(5):675-679. doi: 10.1007/s00192-017-3295-6. Epub 2017 Mar 14.
- Background: PubMed 28259230Marnach ML, Torgerson RR. Vulvovaginal Issues in Mature Women. Mayo Clin Proc. 2017 Mar;92(3):449-454. doi: 10.1016/j.mayocp.2016.10.031.
- Background: PubMed 28056209Filippini M, Del Duca E, Negosanti F, Bonciani D, Negosanti L, Sannino M, Cannarozzo G, Nistico SP. Fractional CO2 Laser: From Skin Rejuvenation to Vulvo-Vaginal Reshaping. Photomed Laser Surg. 2017 Mar;35(3):171-175. doi: 10.1089/pho.2016.4173. Epub 2016 Dec 30.
- Background: PubMed 25160739Portman 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.
- Background: PubMed 28243906Lapii 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.
- Background: PubMed 27484782Ho D, Kraeva E, Wun T, Isseroff RR, Jagdeo J. A single-blind, dose escalation, phase I study of high-fluence light-emitting diode-red light (LED-RL) on human skin: study protocol for a randomized controlled trial. Trials. 2016 Aug 2;17:385. doi: 10.1186/s13063-016-1518-7.
- Background: PubMed 28435253Miyata S, Miyaji H, Kawasaki H, Yamamoto M, Nishida E, Takita H, Akasaka T, Ushijima N, Iwanaga T, Sugaya T. Antimicrobial photodynamic activity and cytocompatibility of Au25(Capt)18 clusters photoexcited by blue LED light irradiation. Int J Nanomedicine. 2017 Apr 4;12:2703-2716. doi: 10.2147/IJN.S131602. eCollection 2017.
- Background: PubMed 28587675Takada A, Matsushita K, Horioka S, Furuichi Y, Sumi Y. Bactericidal effects of 310 nm ultraviolet light-emitting diode irradiation on oral bacteria. BMC Oral Health. 2017 Jun 6;17(1):96. doi: 10.1186/s12903-017-0382-5.
- Background: PubMed 28154914Arunkalaivanan A, Kaur H, Onuma O. Laser therapy as a treatment modality for genitourinary syndrome of menopause: a critical appraisal of evidence. Int Urogynecol J. 2017 May;28(5):681-685. doi: 10.1007/s00192-017-3282-y. Epub 2017 Feb 2.
- Background: PubMed 7731384Nilsson K, Risberg B, Heimer G. The vaginal epithelium in the postmenopause--cytology, histology and pH as methods of assessment. Maturitas. 1995 Jan;21(1):51-6. doi: 10.1016/0378-5122(94)00863-3.
- Background: PubMed 33232011Flores SA, Hall CA. Atrophic Vaginitis(Archived). 2025 Jun 19. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK564341/
- Background: PubMed 20233278Herbenick 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comparison of aesthetic techniques in people with Laxity; Skin and Skin Hyperpigmentation, run by Centro de Atenção ao Assoalho Pélvico at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrícia Lordelo ((71) 8859-2400/3330-1640, pvslordelo@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
External genital Laxity (time frame: 1, 3, 6 and 12 months after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04998578, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2023.