Evaluation of the safety of products for health by doctors dermatologist and gynecologist under normal conditions of use

Not Applicable

• Conditions: Vaginitis, vulvitis and vulvovaginitis in infectious and parasitic diseases classified elsewherea; N77.1

• Registration Number: RBR-88ykxm
• Lead Sponsor: Ipclin - Pesquisa Clínica Integrada

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-05
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Women. Age: 18 to 65 years. Phototype: I to IV. Whole skin of the region. Occasional user of category products

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

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.