Stryphnodendron Adstringens Intimate Soap

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Vaginal Flora Imbalance
• Intervention / Treatment: Drug: Stryphnodendron Adstringens 3% - once daily post bath

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.

• Study Type: Interventional
• Enrollment (Estimated): 33
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sérgio Schalka, MD; Phone Number: (55) (11) 3683-5366; Email: contato@medcinpesquisa.com.br
• Study Contact Backup: Name: Inês P Soares, MD; Phone Number: (55) (11) 3683-5366; Email: contato@medcinpesquisa.com.br

Study Locations

• Brazil
  • São Paulo
    • Osasco, São Paulo, Brazil, 06023-070
      • Medcin Instituto Da Pele

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stryphnodendron Adstringens (Barbatimão); Intimate Soap	Drug: Stryphnodendron Adstringens 3% - once daily post bath; Intimate Soap; Other Names: Barbatimão

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dermatological and gynecological evaluation criteria	Assess the presence of any clinical signs/symptoms in the vulva, anal and vaginal region by visually observing the mons pubis, labia majora, labia minora, clitoris, vaginal vestibule, urethral orifice, perineum and anal region, with application of a 2-point categorical scale (0=no, 1=yes)	Immediately after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment	Clinical signs and/or symptoms of adverse events	Assessment of the occurrence and intensity of erythema, edema, scaling and vesiculation, using a 4-point scale (0=absent, 1=mild, 2=moderate, 3=severe)

Collaborators and Investigators

• Sponsor: Biolab Sanus Farmaceutica
• Collaborators: Medcin Instituto da Pele

Study record dates

Study Major Dates

• Study Start (Estimated): November 5, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: July 6, 2023
• First Submitted That Met QC Criteria: October 10, 2023
• First Posted (Actual): October 17, 2023

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: EN22-0629-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No