Assessment of proctological, gynecological and dermatological acceptability using the product at home

Not Applicable

• Conditions: healthy volunteers; M01.774

• Registration Number: RBR-8n2y6sq
• Lead Sponsor: Ipclin Instituto de Pesquisa Clínica Integrada Ltda

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-22
• Last Update Posted: 29 May 2023
• Study Completion: 2023-06-21

Recruitment & Eligibility

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

Inclusion Criteria

Gender: female; Age: 18 to 59 years; Phototype: I to IV; Intact skin in the region; Occasional user of products in the category

Exclusion Criteria

Skin marks in the experimental area that interfere with the evaluation of possible chemical reactions (pigmentation disorders, vascular malformations, scars, increased hairiness, freckles and nevus in large numbers, sunburn); Pregnant or lactating women; Participants with a history of allergies to the material used in the study; History of atopy; Use of vaginal cream; Participants with a history of allergies to cosmetic products in the test category; Recent gynecological surgeries; discharges; People with immunodeficiencies; Kidney, heart or liver transplants; Active cell pathologies that may interfere with the study (vitiligo, psoriasis, lupus, atopic dermatitis); Topical use with corticoid in the experimental area up to 8 days before the beginning of the study. Any condition not mentioned above which, in the opinion of the investigator, may compromise the study evaluation
Note: the participants included are instructed not to change their diet, exercise routine and contraceptive method. Also, do not use products from the same category as the product tested in the experimental region.

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 studied population, after using the product in real conditions, guaranteeing the safety of the product to the community.

Secondary Outcome Measures

Name	Time	Method
It is expected to guarantee to the final users the safety of the product, an intimate lubricant, from the verification that none of the participants presented discomfort or clinical signs