Evaluation of the dermatological acceptability of a health product using the product at home

Not Applicable

• Conditions: healthy volunteers; M01.774

• Registration Number: RBR-10d7dj3w
• 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: 2023-03-28
• Last Update Posted: 29 May 2023
• Study Completion: 2023-08-26

Recruitment & Eligibility

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

Inclusion Criteria

Intact skin in the product application region (intimate region); Age 18 to 65 years; Women; Participants with phototypes I, II, III and IV (according to the Fitzpatrick classification); No history of irritation/allergy to the material used in the study; Having signed the Free and Informed Consent Form (TCLE); Participants who want to participate in the study without financial profit

Exclusion Criteria

Participants who have or have had symptoms characteristic of COVID-19 for at least 7 days prior to the survey date; Participants who are part of the COVID-19 risk group (elderly people, people with heart and lung diseases, people with immunodeficiencies, people undergoing transplants or undergoing chemotherapy; people with kidney diseases or on dialysis; diabetics, people with liver diseases and obese people) ; participants who refuse to participate in the study in question; 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); Active dermatoses (local and disseminated) that may interfere with the study results; History of dermatological pathologies in the study region; History of allergic reactions, irritation or intense feelings of discomfort to topical products: cosmetics and medications; Participants with a history of allergy to the material used in the study; Intense sun exposure or tanning session up to 15 days before the initial assessment; Prediction of intense sun exposure or tanning session, during the study period; Provision of bathing in the sea, swimming pool or sauna during the study; Participants who practice water sports; Use of the following topical systemic medications: immunosuppressants, antihistamines, non-steroidal anti-inflammatory drugs, and corticosteroids up to two weeks before selection; Treatment with acidic vitamin A and/or its derivatives orally or topically up to 01 month before the beginning of the study; Prediction of vaccination during the study or up to 03 weeks before the study, in order not to correlate the possible side effects of the vaccine with the study in question; Any condition not mentioned above that, in the opinion of the investigator, may compromise the evaluation of the study; Note: the participants included are instructed not to change their diet, cosmetic and hygiene habits, 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: Intervention
• Study Design: Not specified