An interventional study of Comparison of aesthetic techniques in Laxity; Skin, Skin Hyperpigmentation and Needlestick Puncture, sponsored by Centro de Atenção ao Assoalho Pélvico. Recruiting at 2 sites in Brazil. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-12-11.
Sponsored by Centro de Atenção ao Assoalho Pélvico · Not applicable, Interventional, and Treatment
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.
127 studies on the registry are indexed under Hyperpigmentation; 28 are open to participants now.
This study's planned enrollment of 112 is above the median of 32 across 113 interventional studies indexed under Hyperpigmentation.
Browse Hyperpigmentation studies →Centro de Atenção ao Assoalho Pélvico is the lead sponsor of 17 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Participants will only perform microneedling
Device: Comparison of aesthetic techniques
Microneedling associated with the use of outpatient cosmetics
Device: Comparison of aesthetic techniques
Microneedling associated with home use cosmetics
Device: Comparison of aesthetic techniques
Participants will perform only non-ablative radiofrequency
Device: Comparison of aesthetic techniques
Comparison of aesthetic techniques for rejuvenation and glazing of the genital region
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.
Time frame: 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.
Time frame: 1, 3, 6 and 12 months after treatment
Sexual function
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
Female Genital Self-Image
It will be evaluated through the Female Genital Self-Image Scale (FGSIS) \> 26
Time frame: 1, 3, 6 and 12 months after treatment
Melasma Quality of Life
It will be evaluated through the Melasma Quality of Life Scale (MELASQoL).
Time frame: 1, 3, 6 and 12 months after treatment
Plan to share: No
Started Oct 2021 (actual). Primary completion is estimated for Oct 2024, 36 months after the start.
Of 37 non-industry interventional studies with no phase under Hyperpigmentation, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 27. This study's planned 36 months is above that.
Counting every sponsor, half of 64 studies reached it within 7 months; a quarter within 3 and three quarters within 25.
How these figures are worked out, and which studies are left out of them.
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Centro de Atenção ao Assoalho Pélvico