Stryphnodendron Adstringens Intimate Soap

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Biolab Sanus Farmaceutica
• Collaborator: Medcin Instituto da Pele

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.