Dermacyd PH_DESILSTY_FR (Lactic Acid) - Photo Evaluation - Stay on Frutal
NCT ID: NCT00933257
Last Updated: 2010-09-14
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
PHASE3
27 participants
INTERVENTIONAL
2009-06-30
2009-07-31
Brief Summary
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To demonstrate the absence of photoirritation and potential photosensitization of the product Dermacyd PHDESILSTYFR.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dermacyd PH_DESILSTY_FR (Lactic Acid)
Dermacyd PH\_DESILSTY\_FR (Lactic Acid) sample will be applied like a curative. Physiologic solution and mineral oil will be also used as a control sample.
LACTIC ACID(ND)
Treatment duration 5 weeks
Interventions
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LACTIC ACID(ND)
Treatment duration 5 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* Use of Antiinflammatory 30 days and/or immunossupression drugs 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 with 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.
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_04808
Identifier Type: -
Identifier Source: org_study_id