Dermacyd PH_DETINLYN (Lactic Acid) Tangerine Mix - Compatibility

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00786097

First Posted: November 5, 2008

Last Update Posted: August 25, 2009

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.

Information provided by:

Sanofi

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 PHDETINLYN Tangerine Mix.None.

Condition	Intervention	Phase
Hygiene	Drug: Dermacyd PH_DETINLYN (Lactic Acid)	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Supportive Care
Official Title:	Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability, Dermical Sensitivity) of Dermacyd PH_DETINLYN (Lactic Acid) Tangerine Mix

Resource links provided by NLM:

Drug Information available for: Lactic acid Ammonium lactate

U.S. FDA Resources

Further study details as provided by Sanofi:

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 ]


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

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

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 60 Years (Adult)
Sexes 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 inclusion:

Lactation or gestation
Use of Antiinflammatory and/or immunossupression 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00786097

Locations


Brazil
Sanofi-Aventis Administrative Office
Sao Paulo, Brazil

Sponsors and Collaborators

Sanofi

Investigators


Study Director:	Jaderson Lima	Sanofi

More Information


Responsible Party:	Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier:	NCT00786097 History of Changes
Other Study ID Numbers:	LACAC_L_04305
First Submitted:	November 4, 2008
First Posted:	November 5, 2008
Last Update Posted:	August 25, 2009
Last Verified:	August 2009

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