Hypothesis / aims of study
Genital hyperchromia may cause significant aesthetic discomfort and changes in women, such as low self esteem and inhibition with a partner1. There are no studies in the current literature about using whitening solutions for treating genital hyperchromia. This original study aims to verify the safety of a whitening solution in the female genital region and its impact on sexual function and quality of life.
Study design, materials and methods
Randomized double blind clinical trial, with a sample of 27 women, 14 in test group and 13 in sham group. No sample calculation was performed, as this is a phase 1 study, opting for a convenience sample with a minimum of 10 participants per group being chosen.
The research included women between 18 and 45 years old (non-menopausal) who had complaints of darkening of the genital region ratified by the professional. Participants with genital herpes, healing problems, skin wounds, keloids, skin lesions in the region, pregnant women, laser hair removal or intense pulsed light were excluded. The patients came by spontaneous demand, invited by posters and general communication.
Five chemical peel sessions were performed. A whitening solution (consisting of mandelic acid, ferrulic cytovector, kojic acid and phytic acid) was used for 15 minutes, with an interval of 15 days between sessions. The sham group went through all the steps previously described; their product consisted of a cream with the same color and texture, with no acids in the composition. The person who applied the solutions was blind to which one was involved, as they were identified as "A" and "B". The safety analysis was performed during and after treatment through the professional's medical record (the patients were asked about symptoms such as itching, burning, erythema, pain and hypersensitivity). Evaluation of sexual function was done through the Female Sexual Function Index (FSFI)2 and the quality of life MELASQoL questionnaire was also applied3. The questionnaires were answered before treatment and 15 days after the last session. Descriptive and analytical analysis were performed by Statistical Package for Social Sciences (SPSS, version 14.0) software. The level of significance adopted was 5% for all inferential analyzes. The analysis by intention to treat was performed, being considered the same value of initial and final questionnaires, when there was loss of follow-up. The study was approved by the Institution's Research and Ethics Committee. The patients signed the Informed Consent Form, according to the requirements of resolution 466/12 of the National Health Council.
The comparison between clinical and sociodemographic data showed no statistical difference between groups. Regarding the risk factors, the only variable that presented a significant difference between the groups refers to the type of hair removal process performed by them – 85.7% of the test group used razors, while 53.8% of the sham group used hot wax (p=0.024). When analysing the safety of treatment, none of the patients experienced infections or allergic reactions during treatment. Only one test group patient, who presented no complications during the sessions and intervals between applications, reported minor complications like itching and burning after finishing the treatment. Table 1 presents the intra and intergroup analysis of the questionnaires. According to the FSFI, at the initial moment the groups were similar (p=0.620), showing averages below the cutoff point of 26.5, thus presenting sexual dysfunction. Although the average of the initial test group is below the cutoff point (24.9 + -7.8) and improved above the point after treatment (27.9 + -5.0), there is not statistical difference in the intragroup analysis (p=0.098). When analyzing MelasQol, at the initial moment, there was heterogeneity between the groups, as the test group presented worse median in relation to the sham group: 46 [37-55] and 27 [17.5-46], respectively, p=0.03. After treatment, the test group exhibited a significant reduction of median: 46 [37-55] x 26 [13-51], being statistically significant in the intra-group analysis (p=0.018). When the variation between the final and initial intergroup scores was analyzed, there was only a difference in the FSFI (p=0.04), as shown in Table 2.
Interpretation of results
No adverse effects were observed during the interventions. There was only one woman who reported them after treatment, thought we cannot assume the adverse effects were related to it. The results showed that test group women improved sexual function according to the variability of FSFI scores, which could represent indication criteria for cosmetic treatments. Moreover, the analysis of the variability of scores may have been impaired as the test group had worse quality of life, and the groups were different at the beginning. Additionally, the MelasQol questionnaire was not developed to assess quality of life in women with complaints of genital dyschromia, and it may be necessary to develop a specific cutoff point or adjustment for this purpose. Considering this was a pilot study, the external validity could be questioned, requiring a study with a more robust number of participants.