Hygiene
Conditions
Brief summary
Primary Objective: To demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd PHDESILSTYFR.
Interventions
DRUGLACTIC ACID(ND)
Treatment duration: 6 weeks
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Phototype 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 Antiinflammatory 30 days and/or immunossupression drugs for until 3 months before volunteers selection * Disease which can cause immunosuppresion, such as diabetes, HIV * Personnel history of atopy * History of sensitivity or irritation for topic products * Cutaneous active disease (local and/or general) which can modify the study results * Use of new drugs and/or cosmetics during the study * Cutaneous reactive * Previous participation in studies using the same product in test * Volunteer which has immunodeficiency congenital or acquired * Relevant history or confirmation of alcohol or other drugs abuse * Intolerance detected or suspected for some component of the sample tested * Medecin or sponsor employees or their close family. 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 primary and accumulated dermical irritability and dermical sensitivity by using International Contact Dermatitis Research Group (ICDRG) scale. | From the treatment start to the end of the study( treatment period 6 weeks) |
Countries
Brazil
Outcome results
None listed