Healthy volunteers
Conditions
Interventions
The study will be conducted in a single group of 33 individuals, where: Visit 01 (D0) - gynecological evaluation with visual and static inspection of the pubic hill, large and small lips, clitoris, va
Other
Sponsors
Medcin Instituto da Pele Ltda.
Medcin Instituto da Pele Ltda.
Semina Industria e Comercio LTDA
Eligibility
Sex/Gender
Female
Age
45 Years to 65 Years
Inclusion criteria
Inclusion criteria: Healthy women complaining of vaginal dryness; Age range between 45 and 65 years; Intact skin in the region of product analysis; No history of reaction to topical products
Exclusion criteria
Exclusion criteria: Pregnancy or risk of gestation and or lactation; pathologies and or cutaneous lesions such as psoriasis, sensitive skin, skin cancer, rosacea, atopic dermatitis or other medical criteria to be considered at the time of evaluation; hyperpigmentation in the area of Test that interfere in the evaluation of possible reactions vascular malformations, scars, increased pilosity and large amount of nerves; Active cutaneous pathologies and or lesions local and or disseminated in the evaluation area; use of the following Topical or systemic medications: immunosuppressants, antihistamines, non-hormonal anti-inflammatories, and corticosteroids up to 30 days before selection or considering immunosuppressants, the interval should be 3 months before selection; Decompensated endocrinopathies; Immunosuppression by drugs or active diseases; Relevant clinical history or current evidence of abuse of alcohol or other drugs; Aesthetic or dermatological treatment in the evaluation area up to 04 weeks before selection; Alteration of hygiene habits up to 04 weeks before selection, such as: Alteration of brand and type of body and intimate soaps and etc. ; Atopic or allergic antecedents to category products; Known history or suspected intolerance to Products of the same category; Cutaneous markers in the experimental area that interfere in the evaluation of possible cutaneous reactions vascular malformations, scars, increased pilosity and nevus in large quantity; Participants with Known congenital or acquired immunodeficiency; Professionals directly involved in conducting the present study both from the research center and from the sponsor; Other conditions considered by the appraiser physician as reasonable for Disqualification of the study's participation. If yes, it should be described under observation in the clinical form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Check a certain substance of the product through kinetics of corneometry, immediately after 72 hours of application. ;Check the moisturizing effectiveness of the product after treatment for 28 days according to the mode of use and through the perception of the users. ;Check safety under normal conditions of use by checking for signs of irritability and sensitization of the genital mucosa. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are not expected. | — |
Countries
Brazil
Contacts
Public ContactCarolina ;Flavia Trevisan;Sant´Anna Addor
Semina Industria e Comercio LTDA;Medcin Instituto da Pele Ltda.
Outcome results
None listed