Skip to main content
Clinical Trials/NCT06085898
NCT06085898Not yet recruitingNot Applicable

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

Biolab Sanus Farmaceutica1 site in 1 country33 target enrollmentStarted: November 5, 2023Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
33
Locations
1
Primary Endpoint
Dermatological and gynecological evaluation criteria

Study Overview

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.

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)

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
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.

Arms & Interventions

Stryphnodendron Adstringens (Barbatimão)

Experimental

Intimate Soap

Intervention: Stryphnodendron Adstringens 3% - once daily post bath (Drug)

Outcomes

Primary Outcomes

Dermatological and gynecological evaluation criteria

Time Frame: 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 Outcomes

  • 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))

Investigators

Sponsor
Biolab Sanus Farmaceutica
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials