healthy volunteers
Conditions
Interventions
Study to evaluate the safety and efficacy based on the cosmetic appreciability (opinion of the volunteers) of the investigational cosmetic product. It is expected to include 30 participants, men and w
Sponsors
Ipclin Instituto de Pesquisa Clínica Integrada Ltda
Avenca Indústria Cosmética Eireli -EPP
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to prove the safety and efficacy of the investigational product, under normal conditions of use, according to the opinion of the participants | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to guarantee final users the safety of the product, a vaginal moisturizer, based on the verification that none of the participants showed discomfort or clinical signs. | — |
Countries
Brazil
Contacts
Public ContactCassiano Escudeiro
Ipclin Instituto de Pesquisa Clínica Integrada Ltda
Outcome results
None listed