Evaluation of gynecological and dermatological acceptability of health product under normal use, with PH measurement

Not Applicable

• Conditions: Administration, Intravaginal; E02.319.267.120.500

• Registration Number: RBR-5jm6gw
• Lead Sponsor: abterapi Laboratório de produtos naturais EIRELI EPP

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-05
• 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

Skin markings 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 or lactating women;
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 products of the tested category;
Recent gynecological surgeries;
Discharge;
Carriers of immunodeficiencies;
Kidney, cardiac or liver transplantation;
Active skin conditions that may interfere with the study (vitiligo, psoriasis, lupus, atopic dermatitis)
o 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, may compromise the evaluation of the study.
Note: Participants included are advised not to change their diet, exercise routine and contraceptive method. Also, not to use products from the same category as the product tested in the experimental region.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Verify the acceptability of the investigational product in the studied population, after the use of the product under real conditions, ensuring the product safety community.

Secondary Outcome Measures

Name	Time	Method
The discomfort sensations and clinical signs of each participant will be evaluated, and according to the criteria determined by the gynecologist and dermatologist, the product will be considered dermato and gynecologically safe.