Dermacyd Femina (Lactic Acid) - Photo Dermatological Evaluation of the Irritation and Sensitivity Potential.
Phase 3
Completed
- Conditions
- Hygiene
- Interventions
- Drug: Lactic acid (Dermacyd Femina)
- Registration Number
- NCT00705744
- Lead Sponsor
- Sanofi
- Brief Summary
To prove the absence of photo irritation and photo sensitivity potential of the product Dermacyd Femina.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 26
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description I Lactic acid (Dermacyd Femina) -
- Primary Outcome Measures
Name Time Method 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 to the skin type. 5 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sanofi-aventis
🇧🇷São Paulo, Brazil