Topic Compatibility Dermacyd Wipes - Lactoserum - Hygiene

This study has been completed.

Sponsor:

Information provided by:

Sanofi

ClinicalTrials.gov Identifier:

NCT00371852

First received: August 31, 2006

Last updated: May 15, 2008

Last verified: May 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

August 31, 2006

Last Updated Date

May 15, 2008

Start Date ^ICMJE

May 2006

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Score evaluation of the cutaneous reaction, preconized by International Contact Dermatitis Research Group (ICDRG)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00371852 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

Topic Compatibility Dermacyd Wipes - Lactoserum - Hygiene

Official Title ^ICMJE

Safety Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability and Dermical Sensibility) of Dermacyd Wipes

Brief Summary

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 wipes.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Hygiene

Intervention ^ICMJE

Drug: lactoserum

Study Arm (s)

Not Provided

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

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Phototypes: I, II, III and IV;
Integral skin test in the region;

Exclusion Criteria:

Lactation or gestation
Use of Anti-inflammatory and/or immune-suppression drugs
Personnel history of atopy;
History of sensibilization or irritation for topic products;
Active cutaneous disease;
Use of new drugs and/or cosmetics during the study

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Brazil

Administrative Information

NCT Number ^ICMJE

NCT00371852

Other Study ID Numbers ^ICMJE

LACTO_L_01811

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Sanofi

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Jaderson Lima

Sanofi

Information Provided By

Sanofi

Verification Date

May 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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