Laxity; Skin, Needlestick Puncture, Skin Hyperpigmentation
Conditions
Keywords
microneedling, laxity, Skin Hyperpigmentation
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.
Interventions
DEVICEComparison of aesthetic techniques
Comparison of aesthetic techniques for rejuvenation and glazing of the genital region
Sponsors
Centro de Atenção ao Assoalho Pélvico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
the data of the participants will be collected by evaluators blind to the study and who will not know the allocation of the patients
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| External genital Laxity | 1, 3, 6 and 12 months after treatment | 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. |
| Genital Hyperchromia | 1, 3, 6 and 12 months after treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sexual function | 1, 3, 6 and 12 months after treatment | It will be evaluated through the questionnaire Sexual Quotient - Female Version (QS-F), Female Sexual Function Index (FSFI) |
| Female Genital Self-Image | 1, 3, 6 and 12 months after treatment | It will be evaluated through the Female Genital Self-Image Scale (FGSIS) \> 26 |
| Melasma Quality of Life | 1, 3, 6 and 12 months after treatment | It will be evaluated through the Melasma Quality of Life Scale (MELASQoL). |
Countries
Brazil
Contacts
Primary ContactPatrícia Lordelo
Outcome results
None listed