Hygiene
Conditions
Brief summary
To demonstrate the absence of photoirritation and photosensitization potential of the product Dermacyd PHDETINLYN Sweet Flower.
Interventions
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
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; * 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 and/or immunosuppression 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 of photodermatosis active; * Family or personal antecedent of cutaneous photoinduced neoplasias; * Presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and queratoses 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 | Throughout the study |
| The sensibility will be evaluated according to the skin type. | Throughout the study |
Countries
Brazil
Outcome results
None listed