Evaluation of the proctological, gynecological and dermatological acceptability of a health product using the product at home
- Conditions
- healthy volunteersM01.774
- Registration Number
- RBR-54w3vgs
- Lead Sponsor
- Ipclin Instituto de Pesquisa Clínica Integrada Ltda
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Female
- Target Recruitment
- Not specified
Women; age: 18 to 59 years old; phototype: I to IV; intact skin of the region; occasional user of category products
Skin marks in the experimental area that interfere with the evaluation of possible skin reactions (pigmentation disorders, vascular malformations, scars, increased hairiness, freckles and nevus in large numbers, 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 cosmetic products in the tested category; recent gynecological surgeries; discharges; people with immunodeficiencies, kidney, heart or liver transplants; active skin 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 beginning 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 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 the safety of the product from the verification that none of the participants showed discomfort or clinical signs