Dermacyd Femina (Lactic Acid) Pocket BR - Compatibility
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00783861 |
Recruitment Status
:
Completed
First Posted
: November 3, 2008
Last Update Posted
: December 19, 2008
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Sponsor:
Sanofi
Information provided by:
Sanofi
Tracking Information | ||||
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First Submitted Date ICMJE | October 31, 2008 | |||
First Posted Date ICMJE | November 3, 2008 | |||
Last Update Posted Date | December 19, 2008 | |||
Study Start Date ICMJE | October 2008 | |||
Actual Primary Completion Date | November 2008 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
The absence of primary and accumulated dermical irritability and dermical sensitivity will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale. [ Time Frame: Throughout the study ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT00783861 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Dermacyd Femina (Lactic Acid) Pocket BR - Compatibility | |||
Official Title ICMJE | Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability, Dermical Sensitivity) of Dermacyd Femina Pocket BR. | |||
Brief Summary | To demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd Femina (Lactic Acid) Pocket BR. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 3 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Supportive Care |
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Condition ICMJE | Hygiene | |||
Intervention ICMJE | Drug: Lactic Acid
Lactic Acid (Dermacyd Femina) |
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Study Arms | Experimental: 1
Lactic Acid (Dermacyd Femina)
Intervention: Drug: Lactic Acid |
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Publications * | Not Provided | |||
* 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 | |||
Actual Enrollment ICMJE |
54 | |||
Original Actual Enrollment ICMJE |
50 | |||
Study Completion Date | Not Provided | |||
Actual Primary Completion Date | November 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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Sex/Gender |
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Ages | 18 Years to 60 Years (Adult) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Brazil | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00783861 | |||
Other Study ID Numbers ICMJE | LACAC_L_04370 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Medical Affairs Study Director, sanofi-aventis | |||
Study Sponsor ICMJE | Sanofi | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Sanofi | |||
Verification Date | December 2008 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |