Hygiene
Conditions
Brief summary
To prove the absence of photo irritation and photo sensitivity potential of the product Dermacyd Femina Delicata.
Interventions
DRUGLactic acid (Dermacyd Femina Delicata)
Sponsors
Sanofi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Phototype Skin II and III; * Integral skin test in the region;
Exclusion criteria
* Lactation or gestation; * Use of Anti-inflammatory and/or immuno-suppression drugs 15 days before the selection; * Diseases which can cause immunity decrease, such as HIV, diabetes; * Use of drug photosensitizer; * History of sensitivity or irritation for topic products; * Active cutaneous disease which can change the study results; * History or photodermatosis active; * Family or personal antecedent of cutaneous photoinduced neoplasias; * Presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and keratoses actinium; * Intense solar exposure in the study area; * Use of new drugs or cosmetics during the study; 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 photo irritation test and the photosensitivity will be measured using UVA irradiation and evaluated according International Contact Dermatitis Research Group (ICDRG) scale. | 5 weeks |
| The sensibility will be evaluated according the skin type. | 5 weeks |
Countries
Brazil
Outcome results
None listed