Dermacyd Femina (Lactic Acid) Pocket BR - Compatibility

Tracking Information
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; (submitted: October 31, 2008)	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
Condition ICMJE	Hygiene
Intervention ICMJE	Drug: Lactic Acid; Lactic Acid (Dermacyd Femina)
Study Arms	Experimental: 1; Lactic Acid (Dermacyd Femina); Intervention: Drug: Lactic Acid
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: December 18, 2008)	54
Original Actual Enrollment ICMJE; (submitted: October 31, 2008)	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: Age between 18 and 60 years old;; Phototype Skin I,II, III e IV; 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 Antiinflammatory and/or immunosuppression drugs one month before the study;; Personnel history of atopy;; History of sensitivity or irritation for topic products;; Active cutaneous disease;; 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.
Sex/Gender	Sexes Eligible for Study: Female
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	Study Director: Jaderson Lima Sanofi
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