Stryphnodendron Adstringens Intimate Soap

Study Overview
=================
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.

Official Title
-----------------
Assessment of Dermal Acceptance, Gynecological and pH Maintenance With Microbiological Analysis of Vaginal Secretion for Cosmetic Product

Conditions
-----------------
Vaginal Flora Imbalance

Intervention / Treatment
-----------------
* Drug: Stryphnodendron Adstringens 3% - once daily post bath


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stryphnodendron Adstringens (Barbatimão)<br>Intimate Soap | Drug: Stryphnodendron Adstringens 3% - once daily post bath<br>* Intimate Soap<br>* Other names: Barbatimão;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Immediately after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment | Clinical signs and/or symptoms of adverse events | 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) |