Dermacyd PH_DETINLYN (Lactic Acid) Sweet Flower - Compatibility - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00785655

Purpose

To demonstrate the absence of irritation potential (primary dermical irritability and cumulated dermical irritability) and allergy (sensibilization) of the product Dermacyd PHDETINLYN Sweet Flower.

Condition	Intervention	Phase
Hygiene	Drug: Dermacyd PH_DETINLYN (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, 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 PH_DETINLYN (Lactic Acid) Sweet Flower

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:	53
Study Start Date:	July 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

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

Eligibility

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

Criteria

Inclusion criteria:

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 immunossupression drugs
Personnel history of atopy

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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: NCT00785655

Locations

Brazil
Sanofi-Aventis Administrative Office
Sao Paulo, Brazil

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Jaderson Lima

Sanofi-Aventis

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	LACAC_L_04299
Study First Received:	November 4, 2008
Last Updated:	November 4, 2008
ClinicalTrials.gov Identifier:	NCT00785655
Health Authority:	Brazil: National Health Surveillance Agency

ClinicalTrials.gov processed this record on January 16, 2009