Assessment of the hydration potential of a gynecological product and evaluation of the appearance of allergies or irritations.
- Conditions
- Healthy volunteersM01.774.500
- Registration Number
- RBR-94vwv2
- Lead Sponsor
- Medcin Instituto da Pele Ltda.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
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
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.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Check a certain substance of the product through kinetics of corneometry, immediately after 72 hours of application.<br>;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.<br><br>;Check safety under normal conditions of use by checking for signs of irritability and sensitization of the genital mucosa.
- Secondary Outcome Measures
Name Time Method Secondary outcomes are not expected.