Comparing techniques for rejuvenating the genital area
Comparison Of Aesthetic Techniques For Rejuvenation Of Genital Region: A Randomized Clinical Trial
NA · Centro de Atenção ao Assoalho Pélvico · NCT04998578
This study is testing whether microneedling or radiofrequency treatments work better to improve skin tightness and color in the genital area for women aged 18 to 65.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 112 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | Centro de Atenção ao Assoalho Pélvico (other) |
| Locations | 2 sites (Salvador, Bahia and 1 other locations) |
| Trial ID | NCT04998578 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness and safety of microneedling compared to non-ablative radiofrequency techniques for treating skin laxity and hyperpigmentation in the female external genitalia. The microneedling technique involves using a roller with small needles to create a mechanical stimulus without damaging the skin. The study aims to determine if microneedling provides better clinical improvement in rejuvenation and skin tone unification. The trial includes women aged 18-65 who experience these aesthetic concerns.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18-65 with skin laxity and hyperpigmentation in the genital area.
Not a fit: Patients who have existing dermatoses, are pregnant, or use anticoagulant medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a safer and more effective non-invasive treatment option for women seeking aesthetic improvements in the genital region.
How similar studies have performed: While non-invasive techniques for skin rejuvenation have shown success in other areas, this specific approach for genital rejuvenation is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Salvador, Bahia and 1 other locations
- Centro de Atenção ao assoalho pélvico — Salvador, Bahia, Brazil (RECRUITING)
- Centro de Atenção ao Assoalho Pelvico — Salvador, Ba, Brazil (RECRUITING)
Study contacts
- Study coordinator: Patrícia Lordelo
- Email: pvslordelo@hotmail.com
- Phone: (71) 8859-2400/3330-1640
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Laxity, Skin, Skin Hyperpigmentation, Needlestick Puncture, microneedling, laxity