Clinical trial NCT04998578: Comparison Of Aesthetic Techniques For Rejuvenation Of Genital Region: A Randomized Clinical Trial
Official title: Comparison Of Aesthetic Techniques For Rejuvenation Of Genital Region: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Laxity; Skin
Skin Hyperpigmentation
Needlestick Puncture
Keywords: microneedling
laxity
Skin Hyperpigmentation
Lead sponsor: Centro de Atenção ao Assoalho Pélvico
Sponsor class: OTHER
First posted: 2021-08-10
Enrollment: 112
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: External genital Laxity
timeFrame: 1, 3, 6 and 12 months after treatment
measure: Genital Hyperchromia
timeFrame: 1, 3, 6 and 12 months after treatment
Secondary outcomes:
measure: Sexual function
timeFrame: 1, 3, 6 and 12 months after treatment
measure: Female Genital Self-Image
timeFrame: 1, 3, 6 and 12 months after treatment
measure: Melasma Quality of Life
timeFrame: 1, 3, 6 and 12 months after treatment
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Centro de Atenção ao assoalho pélvico
state: Bahia
city: Salvador
country: Brazil
facility: Centro de Atenção ao Assoalho Pelvico
state: Ba
Study officials:
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