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

Laxity; Skin Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04998578
• Other study ID #: Caap
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: October 1, 2024

Study information

• Verified date: December 2023
• Source: Centro de Atenção ao Assoalho Pélvico
• Contact: Patrícia Lordelo
• Phone: (71) 8859-2400/3330-1640
• Email: pvslordelo[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperpigmentation
• Laxity; Skin
• Needlestick Injuries
• Skin Hyperpigmentation

Intervention

Device:
• Comparison of aesthetic techniques
Comparison of aesthetic techniques for rejuvenation and glazing of the genital region

Locations

Country	Name	City	State
Brazil	Centro de Atenção ao Assoalho Pelvico	Salvador	Ba
Brazil	Centro de Atenção ao assoalho pélvico	Salvador	Bahia

Sponsors (1)

Lead Sponsor	Collaborator
Centro de Atenção ao Assoalho Pélvico

Country where clinical trial is conducted

Brazil, 

References & Publications (18)

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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. — View Citation

Doddaballapur S. Microneedling with dermaroller. J Cutan Aesthet Surg. 2009 Jul;2(2):110-1. doi: 10.4103/0974-2077.58529. — View Citation

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. — View Citation

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. — View Citation

Flores SA, Hall CA. Atrophic Vaginitis. 2022 Oct 31. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK564341/ — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Female Genital Self-Image	It will be evaluated through the Female Genital Self-Image Scale (FGSIS) > 26	1, 3, 6 and 12 months after treatment
Secondary	Melasma Quality of Life	It will be evaluated through the Melasma Quality of Life Scale (MELASQoL).	1, 3, 6 and 12 months after treatment