Hygiene
Conditions
Brief summary
To prove the safety of the gynaecological formulation in normal conditions of use.
Interventions
DRUGDermacyd PH_DETINLYN Tangerine Mix (Lactic Acid)
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
10 Years to 20 Years
Healthy volunteers
Yes
Inclusion criteria
* Integral skin test in the region; * Use of cosmetic product of the same category; * Willingness in following the study procedures and to be present in the clinic at the days and scheduled time;
Exclusion criteria
* Lactation or gestational risk or gestation; * Use of Anti-inflammatory, immunosuppression or antihistaminic drugs; * Atopic antecedent or allergic to cosmetic product; * Active cutaneous disease in the evaluation area; * Diseases which cause immunology decrease, such as diabetes and HIV; * Endocrinal pathologies; * Intense solar exposure 15 days before the evaluation; * Treatment until four months before the selection 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 |
|---|---|
| The absence of irritation and the good acceptability will be evaluated using one specific scale which describes the intensity of the reaction. | From the treatment start to the end of the study |
Countries
Brazil
Outcome results
None listed