Dermacyd Breeze (Lactic Acid) Pocket BR - Compatibility

This study has been completed.

First Received: October 31, 2008 Last Updated: December 18, 2008 History of Changes

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00784121

Purpose

To demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd Breeze (Lactic Acid) Pocket BR.

Condition	Intervention	Phase
Hygiene	Drug: Lactic Acid	Phase III

Drug Information available for: Lactic acid Ammonium lactate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability, Dermical Sensitivity) of Dermacyd Breeze Pocket BR.

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Enrollment:	54
Study Start Date:	October 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Lactic Acid (Dermacyd Breeze)	Drug: Lactic Acid Lactic Acid (Dermacyd Breeze)

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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;
Personal 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00784121

Locations

Brazil
Sanofi-Aventis Administrative Office
Sao Paulo, Brazil

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Jaderson Lima

Sanofi-Aventis

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	LACAC_L_04366
Study First Received:	October 31, 2008
Last Updated:	December 18, 2008
ClinicalTrials.gov Identifier:	NCT00784121 History of Changes
Health Authority:	Brazil: National Health Surveillance Agency

ClinicalTrials.gov processed this record on May 06, 2009