Dermatological Evaluation of Topic Compatibility-Dermacyd Tina Gel Tangerina Mix
This study has been completed.
Sponsor:
Sanofi-Aventis
Information provided by:
Sanofi-Aventis
ClinicalTrials.gov Identifier:
NCT00669058
First received: April 23, 2008
Last updated: January 27, 2009
Last verified: January 2009
Tracking Information | |||||
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First Received Date ICMJE | April 23, 2008 | ||||
Last Updated Date | January 27, 2009 | ||||
Start Date ICMJE | December 2007 | ||||
Primary Completion Date | January 2008 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
The absence of primary and accumulated dermal irritability and dermal sensitivity will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale. [ Time Frame: six weeks ] [ Designated as safety issue: Yes ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00669058 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE | |||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Dermatological Evaluation of Topic Compatibility-Dermacyd Tina Gel Tangerina Mix | ||||
Official Title ICMJE | Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability, Dermical Sensitivity) of Dermacyd Tina Gel Tangerina Mix. | ||||
Brief Summary | The purpose of this study is to demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd Tina Gel Tangerina Mix |
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Detailed Description | |||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 3 | ||||
Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
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Condition ICMJE | Healthy | ||||
Intervention ICMJE | Drug: Lactic acid (Dermacid) | ||||
Study Arm (s) | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 52 | ||||
Completion Date | |||||
Primary Completion Date | January 2008 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. |
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Gender | Female | ||||
Ages | 18 Years to 60 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | Brazil | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00669058 | ||||
Other Study ID Numbers ICMJE | LACAC_L_03736 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | GMA-CO/Medical Director, sanofi-aventis administrative office France | ||||
Study Sponsor ICMJE | Sanofi-Aventis | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Sanofi-Aventis | ||||
Verification Date | January 2009 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |