Stryphnodendron Adstringens Intimate Soap

NCT06085898 | Unknown

• 1 other identifier: EN22-0629-01
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaginal Flora Imbalance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (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)

Study Arms (1)

Stryphnodendron Adstringens (Barbatimão)

EXPERIMENTAL

Intimate Soap

Drug: Stryphnodendron Adstringens 3% - once daily post bath

Interventions

Stryphnodendron Adstringens 3% - once daily post bath DRUG

Intimate Soap

Also known as: Barbatimão

Stryphnodendron Adstringens (Barbatimão)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biolab Sanus Farmaceutica: lead
• Medcin Instituto da Pele: collaborator

Study Sites (1)

Medcin Instituto da Pele

Osasco, São Paulo, 06023-070, Brazil

Location

Central Study Contacts

Sérgio Schalka, MD

CONTACT

(55) (11) 3683-5366; contato@medcinpesquisa.com.br

Inês P Soares, MD

CONTACT

(55) (11) 3683-5366; contato@medcinpesquisa.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: October 17, 2023
• Study Start: November 5, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: October 17, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)