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Stryphnodendron Adstringens Intimate Soap

Sponsored by Biolab Sanus Farmaceutica

About this trial

Last updated 2 years ago

Study ID

EN22-0629-01

Status

Not yet recruiting

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18 to 45 Years
Female
Female

Trial Timing

Ended 2 years ago

What is this trial about?

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.

What are the participation requirements?

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).

No

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.

Locations

Location

Status