Female Dry Genital Mucosa
Conditions
Brief summary
To evaluate the safety of an investigational product through the verification of signs of irritability and sensitization of the genital mucosa, as well as the instrumental moisturizing efficacy by TEWL and barrier integrity analysis, in addition to the efficacy perceived by the volunteers.
Interventions
OTHERIntimate Lubricant Gel
Sponsors
Kley Hertz S/A
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy female sex with active sex life; * Age group: between 45 and 65 years old; * Menopause for at least six months; * Whole skin in the region of product analysis; * No history of reaction to products of the same category * Understanding, agreement and signature of the Term of Free and Informed Consent.
Exclusion criteria
* Gestation or risk of gestation; * Use of anti-inflammatory / immunosuppressive drugs (in the last 30 days and during the study); * Active cutaneous pathologies (local and / or disseminated) in the evaluation area; * Pathologies that cause suppression of immunity, such as diabetes, HIV, etc.; * Endocrine pathologies such as thyroid disorders, ovarian or adrenal gland disorders; * Any infection in the region of analysis of the product diagnosed at the time of inclusion; * Other conditions considered by the investigating physician as reasonable for disqualification of the individual from the study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the product's efficiency as a moisturizer through subjective evaluation | 30 days |
Outcome results
None listed