Hygiene
Conditions
Brief summary
Primary Objective: To demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergic potential (sensibilization) of the product Dermacyd Infantile.
Interventions
DRUGLACTIC ACID(ND)
Dermacyd Infantile (Lactic Acid)
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Photo type Skin I,II, III e IV * Integral skin test in the region * Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion.
Exclusion criteria
* Lactation or gestation * Use of Anti-inflammatory 30 days and/or immunosuppressant drugs during 3 months before the selection * Diseases which can cause immunity decrease, such as HIV, diabetes * Previous atopy * History of sensitivity or irritation for topic products * Active cutaneous diseases which can interfere in the study results * Use of new drugs and/ or cosmetics during the study * Cutaneous reactivity * Previous participation in studies, which had used the product * Volunteers who have immunodeficiency congenital or acquired * Relevant clinical history or present evidence of alcohol abuse or others drugs * Non tolerance to some component of the study product. 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 primary and accumulated dermic irritability and dermic sensitivity will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale. | During 6 weeks (i.e. treatment period) |
Countries
Brazil
Outcome results
None listed