Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
25 participants
INTERVENTIONAL
2009-02-28
2009-03-31
Brief Summary
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To demonstrate the absence of photo irritation and photosensitization potential of the product Dermacyd Infantile (Lactic Acid).
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Dermacyd infantile (Lactic Acid)
5 weeks treatment
LACTIC ACID(ND)
Dermacyd infantile (Lactic Acid)
Interventions
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LACTIC ACID(ND)
Dermacyd infantile (Lactic Acid)
Eligibility Criteria
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Inclusion Criteria
* 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 Anti-inflammatory drugs 30 days and/or immunosuppressant drugs during 3 months before the selection
* Diseases which can cause immunity decrease, such as HIV, diabetes
* Previous atopy
* History of sensitivity or irritation for topic products
* Active cutaneous diseases which can interfere in the study results
* Use of new drugs and/ or cosmetics during the study
* Cutaneous reactivity
* Previous participation in studies, which had used the product
* Volunteers who have immunodeficiency congenital or acquired.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
18 Years
60 Years
ALL
Yes
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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sanofi-aventis
Principal Investigators
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Jaderson Lima
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis Administrative Office
São Paulo, , Brazil
Countries
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Other Identifiers
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LACAC_L_04680
Identifier Type: -
Identifier Source: org_study_id
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