The hypothesis is raised of improving the status of vagnal microbiota with a non-hormonal topical product in early situations of dysbiosis in which the vaginal pH is elevated and the patient may or may not be symptomatic, in order to try to prevent the appearance of future established vaginal infections.
Between 18 and 45 years of age, inclusive.
Who are attending a gynecological visit for any reason and who are in the first phase of the menstrual cycle, between the end of menstruation and before ovulation (approximately between days 9 and 15).
With regular menstrual cycles of between 24 and 35 days.
Who are able to understand and sign the informed consent after the nature of the study has been fully explained to them.
Diagnosis of another vaginal or vulvar condition that may confuse the interpretation of the response to the investigational product (erosive lichen planus, inflammatory desquamative vaginitis, or contact dermatitis involving the vulvar epithelium).
Diagnosis of cervical intraepithelial neoplasia (CIN), cervical carcinoma, or endometrial neoplasia.
Active genitourinary infections (VVC, N. gonorrhoeae, C. trachomatis, or T. vaginalis) at the time of inclusion or within 15 days prior to inclusion in the study.
Active genital lesions (ulcers or vesicles compatible with herpes or warts) or genital bleeding.
Parallel
Palomacare® vaginal gel is a medical device with CE class IIa.
DeviceThe duration of the study for each patient will be approximately 11-12 days and the treatment for groups A and B will be 6 days. In a first pilot study in asymptomatic women, a tendency towards a positive effect on the composition of vaginal fluid was already observed, as assessed by diagnostic tests and classified using a Likert scale. A subsequent study showed that treatment with a different vaginal gel but with an identical concentration of ingredients from Palomacare® vaginal gel, for 21 consecutive days, is able to improve the composition of vaginal fluid. Based on these preliminary data, it is possible to hypothesize that the action of Palomacare® vaginal gel will have a positive effect on the composition of vaginal fluid in patients affected by dysbiosis, whether asymptomatic or not.
Effect of Palomacare® vaginal gel on vaginal microbiota (VM)
To evaluate the effect of Palomacare® vaginal gel on VM, the change in microbial diversity, vaginotype and taxonomic profile of the vaginal microbiome will be analyzed between V1 and V2 in each group.
Effect of Palomacare® vaginal gel on symptoms and pH
To assess the effect of Palomacare® vaginal gel on: * Symptoms (amine odour, leucorrhoea and itching): for each symptom an VAS intensity scale will be used and the time to show changes in each of the symptoms will be assessed by directly asking the patient. * Vaginal pH: vaginal pH refers to the degree of acidity of the vaginal environment. Adequate vaginal pH levels should be between 3.8 - 4.4. However, these vary throughout the woman's cycle and at different stages of life. The researcher will carry out this measurement at visit 1 and visit 2, noting the numerical value of the patient's vaginal pH.
Satisfaction with the use of Palomacare® vaginal gel
To assess the degree of satisfaction regarding the use of Palomacare® vaginal gel using a 5-point Likert scale at visit 2.
Safety and tolerability of Palomacare® vaginal gel
To assess the safety and tolerability of Palomacare® vaginal gel using a 5-point Likert-type scale at visit 2 and by describing the incidence, nature and severity of adverse events (AEs) throughout the study.
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