Hygiene
Conditions
Brief summary
Primary Objective: To prove the safety of the gynecological formulation in normal conditions of use.
Interventions
DRUGLACTIC ACID(ND)
Treatment duration: 21 consecutive days
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Integral vaginal mucosa in the product analysis region * Use the same category cosmetics products * Willingness in following the study procedures and to be present in the clinic at the days and scheduled time
Exclusion criteria
* Use of Anti-inflammatory, immunossupression or antihistaminics drugs * Allergic or atopic history to cosmetics products * Cutaneous active disease (local and/or general) in the evaluated area * Disease which can cause immunosuppresion, such as diabetes, HIV * Endocrinology pathology such as thyroid gland, ovary and adrenal gland * Intensive solar exposure until 15 days before evaluation * Gynecological treatment until four weeks before the study * Other reason considered by the investigator as a reason for not being included. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the absence of irritation and the good acceptability by using one specific scale which describes the intensity of the reaction. | From the treatment start to the end of the study (treatment period 21 consecutive days) |
Countries
Brazil
Outcome results
None listed