Stryphnodendron Adstringens Intimate Soap
Launched by BIOLAB SANUS FARMACEUTICA · Oct 10, 2023
Trial Information
Current as of August 23, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a product called Stryphnodendron Adstringens Intimate Soap, which is designed for women experiencing an imbalance in their vaginal flora. The aim of the trial is to assess how safe this intimate soap is for use, specifically looking at how it affects the skin and vaginal health over time. The study will involve 33 women aged between 18 and 45 who will participate at a single research center.
To be eligible for this trial, participants should have regular menstrual cycles, a specific vaginal pH level, and healthy skin in the area where the soap will be tested. They should also be comfortable using similar cosmetic products. Throughout the study, participants will have their skin and vaginal health assessed at the beginning and end, including pH measurements and microbiological analysis. It’s important to note that women who are pregnant, breastfeeding, or have certain medical conditions or recent health issues will not be able to participate. This trial is currently not recruiting participants, but it aims to provide valuable information on the safety of this new intimate soap.
Gender
FEMALE
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.
About Biolab Sanus Farmaceutica
Biolab Sanus Farmacêutica is a leading pharmaceutical company dedicated to the research, development, and commercialization of innovative therapeutic solutions. With a strong focus on enhancing healthcare outcomes, Biolab specializes in a diverse range of therapeutic areas, including oncology, cardiology, and infectious diseases. The company is committed to advancing clinical research through rigorous trials and collaborations, ensuring the highest standards of safety and efficacy in its products. Biolab Sanus Farmacêutica strives to improve the quality of life for patients worldwide, leveraging cutting-edge technology and a robust pipeline of novel treatments.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Osasco, São Paulo, Brazil
Osasco, , Brazil
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported