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.
Who can participate
Age range18 Years – 45 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 se…
What they're measuring
1
Dermatological and gynecological evaluation criteria