NCT06085898

Stryphnodendron Adstringens Intimate Soap

Assessment of Dermal Acceptance, Gynecological and pH Maintenance With Microbiological Analysis of Vaginal Secretion for Cosmetic Product

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Biolab Sanus Farmaceutica · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

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, 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. Participants will remain in the study for a minimum period of 30 days, using the product for the same period according to the flow below: Flow of Visits: Visit 01 (D0) * Participants' consent process after understanding the study; * Initial assessments: safety clinics (dermatologist/gynecologist); * Vaginal pH measurement; * Collection of vaginal secretion; * Dispensing of the usage diary; * Investigational product dispensing. Visit 02 (D30 ±2 days) * Final assessments: clinical safety assessments (dermatologist/gynecologist); * Vaginal pH measurement; * Collection of vaginal secretion; * Collection of the usage diary; * Return of the product; * Subjective questionnaire (self-assessment) to capture possible feelings of discomfort; * Completion of the study.

Conditions

• Vaginal Flora Imbalance

Interventions

Type	Name	Description
DRUG	Stryphnodendron Adstringens 3% - once daily post bath	Intimate Soap

Timeline

• Start date: 2023-11-05
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2023-10-17
• Last updated: 2023-10-17

Locations

1 site across 1 country: Brazil