Atrophic Vaginitis
Conditions
Interventions
Single-center, blind, non-comparative clinical study to evaluate the safety of the investigational product through clinical evaluations in addition to vaginal pH measurements. 33 female participants w
loss of follow-up (participant failure to return on the scheduled date of the visit)
protocol violation
any clinical condition that, at the discretion of the research doctor, prevents the participant from continuing in the protocol, describing the reason, with respective proof
adverse event or intolerance that makes it impossible to continue using the product under study. Any participant who manifests an adverse event or severe degree
Sponsors
helianto farmacêutica limitada
medcin instituto da pele limitada
Eligibility
Sex/Gender
Female
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Female participants aged 18 to 60; Intact skin in the region of product analysis (vaginal mucosa); Be a user of products in the same category; Agreement to follow the trial procedures and attend the Clinical Research Center on the designated days and times for applications and/or evaluations; Understanding, consent and signature of the Free and Informed Consent Form (TCLE)
Exclusion criteria
Exclusion criteria: Pregnancy or risk of pregnancy and/or lactation;Use of antiinflammatory/ immunosuppressive/ antihistamine drugs up to 3 weeks before selection;Skin marks in the experimental area that interfere with the assessment of possible skin reactions (vascular malformations, scars, increased hairiness, large amounts of nevus, sunburn); Atopic or allergic history to products in the same category; Active skin pathologies and/or lesions (local and/or disseminated) in the assessment 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 in the same category; Intense sun exposure up to 15 days before the assessment; Aesthetic or dermatological treatment in the evaluation area up to 4 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 to be reasonable for disqualification from participation in the study. If yes, it should be described in observation in the clinical record
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Confirm, in real conditions of use, the absence of risk of irritation and capture sensations of discomfort in the studied population, under dermatological and gynecological evaluation criteria | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess pH maintenance via pH strip readings | — |
Countries
Brazil
Contacts
Public ContactFlavia Addor
Medicin Instituto da Pele Ltda
Outcome results
None listed