Dermatological Evaluation of Topic Compatibility-Dermacyd Tina Gel Tangerina Mix - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00669058

Purpose

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

Condition	Intervention	Phase
Healthy	Drug: Lactic acid (Dermacid)	Phase III

MedlinePlus related topics: Methamphetamine

Drug Information available for: Lactic acid Ammonium lactate Amphetamine Methamphetamine

U.S. FDA Resources

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

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

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 ]

Enrollment:	52
Study Start Date:	December 2007
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

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

Exclusion Criteria:

Lactation or gestation
Use of Antiinflammatory and/or immunosuppression drugs
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00669058

Locations

Brazil
Sanofi-aventis administrative office
São Paulo, Brazil

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Jaderson Lima

Sanofi-aventis administrative office Brazil

More Information

Responsible Party:	sanofi-aventis administrative office France ( GMA-CO/Medical Director )
Study ID Numbers:	LACAC_L_03736
Study First Received:	April 23, 2008
Last Updated:	April 28, 2008
ClinicalTrials.gov Identifier:	NCT00669058
Health Authority:	Brazil: National Health Surveillance Agency

Keywords provided by Sanofi-Aventis:

hygiene

Study placed in the following topic categories:

Methamphetamine
Amphetamine
Healthy

ClinicalTrials.gov processed this record on January 16, 2009