Hygiene
Conditions
Brief summary
Primary Objective: To demonstrate the absence of photoirritation and potential photosensitization of the product Dermacyd Silver Floral.
Interventions
DRUGLACTIC ACID(ND)
Dermacyd Silver Floral (Lactic Acid) sample will be applied like a curative during 5 weeks (treatment period).
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 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 pregnancy * 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 * Concomitant use of photosensitivity drugs * History of sensitivity or photosensitivity withr topic products * Cutaneous active disease which can modify the study results * History or activity of photodermatosis * Personal or family antecedents of cutaneous neoplasia photo induced * Presence of injury precursor of cutaneous neoplasia, such as melanociticos nevus and actinic keratosis * Intense exposure solar in the test region * Use of new drugs and/or cosmetics during the study * Previous participation in studies using the same product in test * 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 |
|---|---|
| Measure of the photo irritation test and the photosensitivity by using UVA irradiation and evaluation according International Contact Dermatitis Research Group (ICDRG) scale. Evaluation of the sensibility according to the skin type. | From the treatment start to the end of the study (treatment period 5 weeks) |
Countries
Brazil
Outcome results
None listed