This is a single-centre, single-blind, non-comparative clinical trial to assess the safety of the investigational product through clinical probability assessment. Thirty-three female participants, aged between 18-45, will be required. Assessment of dermal (dermatological) and gynecological acceptance, in addition to pH measurements and vaginal force collection for microbiological analysis at the beginning and end of the study.
This is a single-centre, single-blind, non-comparative clinical trial to assess the safety of the investigational product through clinical probability assessment. Thirty-three female participants, aged between 18-45, will be required. Assessment of dermal (dermatological) and gynecological acceptance, in addition to pH measurements and vaginal force collection for microbiological analysis at the beginning and end of the study. Participants will remain in the study for a minimum period of 30 days, using the product for the same period according to the flow below: Flow of Visits: Visit 01 (D0) * Participants' consent process after understanding the study; * Initial assessments: safety clinics (dermatologist/gynecologist); * Vaginal pH measurement; * Collection of vaginal secretion; * Dispensing of the usage diary; * Investigational product dispensing. Visit 02 (D30 ±2 days) * Final assessments: clinical safety assessments (dermatologist/gynecologist); * Vaginal pH measurement; * Collection of vaginal secretion; * Collection of the usage diary; * Return of the product; * Subjective questionnaire (self-assessment) to capture possible feelings of discomfort; * Completion of the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
33
Intimate Soap
Medcin Instituto da Pele
Osasco, São Paulo, Brazil
Dermatological and gynecological evaluation criteria
Assess the presence of any clinical signs/symptoms in the vulva, anal and vaginal region by visually observing the mons pubis, labia majora, labia minora, clitoris, vaginal vestibule, urethral orifice, perineum and anal region, with application of a 2-point categorical scale (0=no, 1=yes)
Time frame: Immediately after the intervention
Assessment
Clinical signs and/or symptoms of adverse events
Time frame: Assessment of the occurrence and intensity of erythema, edema, scaling and vesiculation, using a 4-point scale (0=absent, 1=mild, 2=moderate, 3=severe)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.