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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microneedling- Group A | Active Comparator | Participants will only perform microneedling |
|
| Microneedling and outpatient Cosmetics- Group B | Active Comparator | Microneedling associated with the use of outpatient cosmetics |
|
| microneedling and home use cosmetics - Group C | Active Comparator | Microneedling associated with home use cosmetics |
|
| Non-ablative radiofrequency - Group D | Active Comparator | Participants will perform only non-ablative radiofrequency |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparison of aesthetic techniques | Device | Comparison of aesthetic techniques for rejuvenation and glazing of the genital region |
|
| 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 |
| 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 |
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Inclusion Criteria:
• Women aged 18-65 years with skin flaccidity and genital hyperchromia
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrícia Lordelo | Contact | (71) 8859-2400/3330-1640 | pvslordelo@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Atenção ao Assoalho Pelvico | Recruiting | Salvador | Estado de Bahia | 40.290-000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28293790 | Background | 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. | |
| 28259230 | Background | Marnach 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. |
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| ID | Term |
|---|---|
| D003483 | Cutis Laxa |
| D017495 | Hyperpigmentation |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
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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.
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the data of the participants will be collected by evaluators blind to the study and who will not know the allocation of the patients
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 |
| Centro de Atenção ao assoalho pélvico | Recruiting | Salvador | Estado de Bahia | 40290000 | Brazil |
|
| 28056209 | Background | Filippini 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. |
| 25160739 | Background | 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. |
| 28243906 | Background | 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. |
| 27484782 | Background | Ho 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. |
| 28435253 | Background | Miyata 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. |
| 28587675 | Background | Takada 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. |
| 28154914 | Background | Arunkalaivanan 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. |
| 7731384 | Background | Nilsson 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. |
| 33232011 | Background | Flores 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/ |
| 20233278 | Background | 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. |
| 23735570 | Background | Cain 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. |
| 22341089 | Background | McPencow 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. |
| 20808602 | Background | Doddaballapur S. Microneedling with dermaroller. J Cutan Aesthet Surg. 2009 Jul;2(2):110-1. doi: 10.4103/0974-2077.58529. |
| 28690124 | Background | Ramaut L, Hoeksema H, Pirayesh A, Stillaert F, Monstrey S. Microneedling: Where do we stand now? A systematic review of the literature. J Plast Reconstr Aesthet Surg. 2018 Jan;71(1):1-14. doi: 10.1016/j.bjps.2017.06.006. Epub 2017 Jun 17. |
| 22567235 | Background | Fabbrocini G, De Vita V, Fardella N, Pastore F, Annunziata MC, Mauriello MC, Monfrecola A, Cameli N. Skin needling to enhance depigmenting serum penetration in the treatment of melasma. Plast Surg Int. 2011;2011:158241. doi: 10.1155/2011/158241. Epub 2011 Apr 7. |
| 21492397 | Background | Goodman MP. Female genital cosmetic and plastic surgery: a review. J Sex Med. 2011 Jun;8(6):1813-25. doi: 10.1111/j.1743-6109.2011.02254.x. Epub 2011 Apr 14. |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D010859 | Pigmentation Disorders |