Status:
UNKNOWN
Stryphnodendron Adstringens Intimate Soap
Lead Sponsor:
Biolab Sanus Farmaceutica
Collaborating Sponsors:
Medcin Instituto da Pele
Conditions:
Vaginal Flora Imbalance
Eligibility:
FEMALE
18-45 years
Phase:
NA
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, ag...
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, ag...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT06085898
Start Date
November 5 2023
End Date
December 1 2023
Last Update
October 17 2023
Active Locations (1)
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1
Medcin Instituto da Pele
Osasco, São Paulo, Brazil, 06023-070