Clincosm LogoSign in Get a demo

Stryphnodendron Adstringens Intimate Soap

Sponsor
Biolab Sanus Farmaceutica (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06085898
Collaborator
Medcin Instituto da Pele (Other)
33
Enrollment
1
Location
1
Arm
26
Anticipated Duration (Days)
38.6
Patients Per Site Per Month

Study Details

Study Description

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, 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Stryphnodendron Adstringens 3% - once daily post bath
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
33 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Assessment of Dermal Acceptance, Gynecological and pH Maintenance With Microbiological Analysis of Vaginal Secretion for Cosmetic Product
Anticipated Study Start Date :
Nov 5, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Stryphnodendron Adstringens (Barbatimão)

Intimate Soap

Drug: Stryphnodendron Adstringens 3% - once daily post bath
Intimate Soap
Other Names:
  • Barbatimão

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Dermatological and gynecological evaluation criteria [Immediately after the intervention]

      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)

    Secondary Outcome Measures

    1. Assessment [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)]

      Clinical signs and/or symptoms of adverse events

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medcin Instituto da Pele Osasco São Paulo Brazil 06023-070

    Sponsors and Collaborators

    • Biolab Sanus Farmaceutica
    • Medcin Instituto da Pele

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Biolab Sanus Farmaceutica
    ClinicalTrials.gov Identifier:
    NCT06085898
    Other Study ID Numbers:
    • EN22-0629-01
    First Posted:
    Oct 17, 2023
    Last Update Posted:
    Oct 17, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Oct 17, 2023