Dermacyd PH_DETINLYN (Lactic Acid) Sweet Flower - Photo Evaluation.
Study Details
Study Description
Brief Summary
To demonstrate the absence of photoirritation and photosensitization potential of the product Dermacyd PHDETINLYN Sweet Flower.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 1 Dermacyd PH_DETINLYN (Lactic Acid) |
Drug: Dermacyd PH_DETINLYN (Lactic Acid)
|
Outcome Measures
Primary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion criteria:
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Phototype Skin II and III;
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Integral skin test in the region;
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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:
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Lactation or gestation
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Use of Antiinflammatory and/or immunosuppression drugs 15 days before the selection;
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Diseases which can cause immunity decrease, such as HIV, diabetes;
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Use of drug photosensitizer;
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History of sensitivity or irritation for topic products;
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Active cutaneous disease which can change the study results;
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History of photodermatosis active;
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Family or personal antecedent of cutaneous photoinduced neoplasias;
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Presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and queratoses actinium;
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Intense solar exposure in the study area;
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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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Sanofi-Aventis Administrative Office | Sao Paulo | Brazil |
Sponsors and Collaborators
- Sanofi
Investigators
- Study Director: Jaderson Lima, Sanofi
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LACAC_L_04300