Assessment of Dermal Acceptance, Gynecological and pH Maintenance With Microbiological Analysis of Vaginal Secretion for Cosmetic Product
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Dermatological and gynecological evaluation criteria
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Stryphnodendron Adstringens (Barbatimão)
Intimate Soap
干预措施: Stryphnodendron Adstringens 3% - once daily post bath (Drug)
结局指标
主要结局
Dermatological and gynecological evaluation criteria
时间窗: 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)
次要结局
- 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))