Vaginitis, vulvitis and vulvovaginitis in infectious and parasitic diseases classified elsewherea
Conditions
Interventions
This is a clinical study to evaluate the gynecological and dermatological safety of the product for health. It is expected that 35 participants, aged 18 to 65 years and phototypes from I to IV (Fitzpa
Device
C13.351.500.894.906.820
Sponsors
Ipclin - Pesquisa Clínica Integrada
Labterapi Laboratório de produtos naturais EIRELI EPP
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Women. Age: 18 to 65 years. Phototype: I to IV. Whole skin of the region. Occasional user of category products
Exclusion criteria
Exclusion criteria: Cutaneous marks in the experimental area that interfere in the evaluation of possible skin reactions (pigmentation disorders, vascular malformations, scarring, increased hairiness, ephelides and nevus in large quantities, sunburns). Pregnant or nursing mothers. Participants with a history of allergy to the material used in the study. History of atopy. Use of vaginal cream.Participants with a history of allergy to cosmetic products of the category tested. Recent gynecological surgeries. Corrections. Immunodeficiency carriers. Renal, cardiac or hepatic transplanted. Active cutaneous pathologies that may interfere with the study (vitiligo, psoriasis, lupus, atopic dermatitis). Topical use with corticosteroids in the experimental area up to 8 days before the start of the study. Any condition not mentioned above that, in the opinion of the investigator, could compromise the evaluation of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to verify the acceptability of the investigational product in the study population, after the use of the product in real conditions, for 20 +/- 2 days, guaranteeing to the community the safety of the product. The sensations of discomfort and clinical signs of each participant will be evaluated by a dermatologist and, if at least 70% of the participants do not report / show feelings of discomfort or clinical signs, the product will be considered dermato and gynecologically safe. | — |
Secondary
| Measure | Time frame |
|---|---|
| Through the participants' perception, it is hoped to show that the use of the product offers benefits of maintaining the pH and hydration of the skin helping to maintain the region of the vagina healthy, preventing infections, as well as being able to provide a greater sense of well-being. | — |
Countries
Brazil
Contacts
Public ContactCassiano Escudeiro
Ipclin - Pesquisa Clínica Integrada
Outcome results
None listed