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

Centro de Atenção ao Assoalho Pélvico

Status: Enrolling

Conditions: Skin Hyperpigmentation; Laxity; Skin; Needlestick Puncture

Treatments: Device: Comparison of aesthetic techniques

Study type: Interventional

Funder types: Other

Identifiers

NCT04998578

Caap

Details and patient eligibility

About

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.

Full 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.

Enrollment: 112 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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112 participants in 4 patient groups

Microneedling- Group A

Active Comparator group

Description:

Participants will only perform microneedling

Treatment:

Device: Comparison of aesthetic techniques

Microneedling and outpatient Cosmetics- Group B

Active Comparator group

Description:

Microneedling associated with the use of outpatient cosmetics

Treatment:

Device: Comparison of aesthetic techniques

microneedling and home use cosmetics - Group C

Active Comparator group

Description:

Microneedling associated with home use cosmetics

Treatment:

Device: Comparison of aesthetic techniques

Non-ablative radiofrequency - Group D

Active Comparator group

Description:

Participants will perform only non-ablative radiofrequency

Treatment:

Device: Comparison of aesthetic techniques