Vaginal Flora Imbalance
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGStryphnodendron Adstringens 3% - once daily post bath
Intimate Soap
Sponsors
Medcin Instituto da Pele
Biolab Sanus Farmaceutica
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Active and regular menstrual flow; * Vaginal pH value between 3.8 and 4.5; * Intact skin in the product analysis region (vaginal mucosa); * Being a user of cosmetic products of the same category (intimate soap); * Agreement to follow the trial procedures and attendance at the Clinical Research Center on the days and times determined for applications and/or estimates; * Understanding, consent and signature of the Free and Informed Consent Term (TCLE).
Exclusion criteria
* Participants who have been diagnosed with COVID-19 in the last 4 weeks or who have symptoms such as fever, dry cough, tiredness, body aches or other discomforts; * Pregnancy or risk of pregnancy and/or lactation; * Being in the menstrual period; * Use of anti-inflammatory/immunosuppressive/antihistamine drugs up to 3 weeks before selection; * Skin marks in the experimental area that interfere with the evaluation of possible skin reactions (vascular malformations, scars, increased hairiness, large amounts of nevus, sunburn); * Atopic or allergic history to cosmetic products; * Pathologies and/or active skin lesions (local and/or disseminated) in the evaluation area; * Immunosuppression by drugs or active diseases; * Decompensated endocrinopathies; * Relevant medical history or current evidence of alcohol or other drug abuse; * Known history or suspected intolerance to products of the same category; * Aesthetic or dermatological treatment in the evaluation area up to 04 weeks before selection; * Employees of Medcin or the sponsoring company involved in the study, or a close family member of an employee involved in the study; * Other conditions considered by the researcher as reasonable for disqualification from participation in the study. If yes, it should be described in observation in the clinical record.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dermatological and gynecological evaluation criteria | Immediately after the intervention | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment | 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) | Clinical signs and/or symptoms of adverse events |
Countries
Brazil
Contacts
Primary ContactSérgio Schalka, MD
Backup ContactInês P Soares, MD
Outcome results
None listed