Safety evaluation of cosmetic products by gynecologist and dermatologist in normal conditions of use

Not Applicable

• Conditions: N89.8; Other specified noninflammatory disorders of vagina

• Registration Number: RBR-33z3x8
• Lead Sponsor: Avenca Indústria Cosmética

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-25
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Female. Age 18 to 65 years. Phototype I to IV. Intact skin in the test area. Occasional user of the category products.

Exclusion Criteria

Cutaneous marks in the experimental area that interfere with the evaluation of possible skin reactions (pigmentation disorders, vascular malformations, scars, increased hairiness, ephelides and nevus in large quantities, sunburn). Pregnant women or infants. Subjects with a history of allergy to the material used in the study. History of atopy. Use of vaginal cream. Subjects with a history of allergy to cosmetic products of the tested category. Recent gynecological surgeries. Vaginal discharge. Immunodeficiency carriers. Renal, cardiac or hepatic transplanted. Active cutaneous pathologies that may interfere with the study (vitiligo, psoriasis, lupus, atopic dermatitis). Topical use of corticosteroids in the experimental area up to 8 days before the start 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 research product in the studied population, after the use of the product in real conditions, guaranteeing to the community the safety of the product. The sensations of discomfort and clinical signs of each participant will be evaluated by a dermathologist and, if at least 70% of them do not report / show feelings of discomfort / clinical signs, the product will be considered dermato and gynecologically safe;The dermatological and gynecological safety of the product was attested. No study subject presented sensations of discomfort or clinical signs.

Secondary Outcome Measures

Name	Time	Method
<br>Through the perception of the subjects it is shown that the use of the product offers benefits of lubrication and quality of the sexual act and is therefore recommended for women who present reduction of natural vaginal lubrication and / or complaints of dyspareunia