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Evaluation of the gynecological and dermatological acceptability of an intimate moisturizing gloss using the product at home

Evaluation of the gynecological and dermatological acceptability of a moisturizing health gloss product under normal conditions of use_Dic02.2023

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-7gj8dcw
Enrollment
Unknown
Registered
2024-03-11
Start date
2024-02-14
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy volunteers

Interventions

This is a one-arm, double-blind, single-center clinical trial. The survey will be conducted on thirty-five participants. An initial assessment will be carried out at the time of inclusion of medical p

Sponsors

Ipclin Instituto de Pesquisa Clínica Integrada Ltda
Lead Sponsor
SNF cosméticos LTDA
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 59 Years

Inclusion criteria

Inclusion criteria: Women; age: 18 to 59 years; phototype: I to IV; whole skin of the region; occasional user of category products

Exclusion criteria

Exclusion criteria: Skin tags in the experimental area that interfere in the evaluation of possible reactions; Pregnant or lactating women; Participants with a history of allergy to the material used in the study; Atopy history; Use of vaginal cream; Participants with a history of allergy to products in the tested category; Recent gynecological surgeries; discharges; Immunodeficiency carriers; 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 start of the study.; Any condition not mentioned above that, in the opinion of the investigator, could compromise the evaluation of the study

Design outcomes

Primary

MeasureTime frame
It is expected to verify the acceptability of the investigational product, an intimate moisturizing gloss, in the studied population, after using the products in real conditions of use, through dermatological and gynecological medical evaluation of clinical signs and feelings of discomfort, based on the finding of that none of the participants presented discomfort or clinical signs, considering the product as gynecologically and dermatologically tested.

Secondary

MeasureTime frame
It is expected to guarantee the safety of the product, an intimate moisturizing gloss, to the end users, based on the observation that none of the participants presented discomfort or clinical signs.

Countries

Brazil

Contacts

Public ContactCassiano Escudeiro

Ipclin Instituto de Pesquisa Clínica Integrada Ltda

cassiano@ipclin.com.br+55(11) 4087-0092

Outcome results

None listed

Source: REBEC (via WHO ICTRP)