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 range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Dermatological and gynecological evaluation criteria