Lubrication
Conditions
Interventions
Clinical trial to assess the safety of the investigational product, intimate lubricant, by assessing its gynecological acceptability under normal conditions of use. This technique makes it possible to
V03.175.500
Sponsors
Universidade São Francisco - USF
Universidade São Francisco - USF
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Age range between 18 and 65 years; phototypes: I to VI, according to Fitzpatrick classification; female gender; intact skin in the evaluation region; intact mucosa in the evaluation region; agree to adhere to the study procedures and requirements: study time, return(s) to the laboratory to perform the study procedures, single application of the investigational product at Kosmoscience by the client's professional, not to change habits including hygiene during the study period; agree not to perform dermatological or aesthetic treatments until the end of the study and agree not to use any products in the same category as the investigational product; signing of the Free and Informed Consent Form (FICF)
Exclusion criteria
Exclusion criteria: Pregnant or lactating women; skin marks in the experimental area that interfere with the evaluation of possible reactions (pigmentation disorders, vascular malformations, scars, increased hairiness, large amounts of freckles and warts, sunburn); active endocrine pathologies such as thyroid disease, diabetes, ovarian or adrenal gland disorders; presence of active local or disseminated vaginal dermatoses in the study region that may interfere with the results; history of ineffectiveness, allergic reactions, irritation or intense discomfort to topical products: health products or medications; expected vaccination during the study or up to 3 weeks before the study; history of chronic or active gynecological pathologies at the time; not taking vitamin A (acid and/or its derivatives orally or topically up to 1 month before the start of the study); carriers of immunodeficiencies; history of atopy (atopic dermatitis, allergic rhinitis, allergic bronchitis, allergic conjunctivitis, etc.); use of non-hormonal anti-inflammatory drugs, corticosteroids, antihistamines, photosensitizers or immunosuppressants up to 2 weeks before the study (or considering depot corticosteroids, the interval should be 1 month before selection); aesthetic or gynecological treatment up to 4 weeks before the study; unstable hormonal treatments in the last 3 months; people directly involved in the performance of this study and their families; history of lack of adherence or unwillingness to adhere to the study protocol; intense sun exposure or tanning session up to 15 days before the initial evaluation; forecast of intense sun exposure or tanning session during the study period; any condition that, in the researcher's opinion, may compromise the study; participating in another study in the same region of application
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess whether the product under investigation is safe and can prove this through gynecological clinical evaluations after home use, in addition to remaining free from reactions during and after 21 days of use | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcomes are expected. | — |
Countries
Brazil
Contacts
Public ContactAna Tabarini Alves Pinheiro
Kosmoscience Ciência e Tecnologia Cosmética Importação Exportação LTDA
Outcome results
None listed