Evaluation of Efficacy and Gynecological Acceptability of a Product for Health Care
- Conditions
- Healthy volunteers with symptoms of vaginal drynessM01.774.500C13.351.500.894.906.316G03.015.500.937
- Registration Number
- RBR-422ssn
- Lead Sponsor
- Medcin Instituto da Pele Ltda
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Female
- Target Recruitment
- Not specified
33 female participants; aged between 40 and 70 years; with vaginal dryness, presenting normal vaginal mucosa and who want to participate in the research
Gestation or risk of gestation / lactation; Use of anti-inflammatory / immunosuppressive / antihistamine drugs up to 3 weeks prior to screening; active cutaneous conditions; Use of other products in the genital area; Participants who use or intend to use intravaginal or systemic anti-infectives or systemic antifungal therapy during the study; Atopic or allergic history of intravaginal products; Immunosuppression by drugs or active diseases; endocrine disorders; Relevant clinical history or current evidence of alcohol or other drug abuse; Known history or suspected intolerance to products of the same category; Intense sun exposure up to 15 days before evaluation; Dermatological and / or gynecological treatments up to 4 weeks prior to screening;
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To verify the safety of the investigational product, under normal conditions of use, through gynecological evaluations
- Secondary Outcome Measures
Name Time Method To evaluate the perceived efficacy of the research product through a subjective questionnaire and pH measurements