Hygiene
Conditions
Brief summary
The purpose of this study is to demonstrate the absence of photoirritation and photosensitization potential of the product Dermacyd PHDETINBACK 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. The sensibility will be evaluated according to the skin type. | Throughout the study |
Countries
Brazil
Outcome results
None listed