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
  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 wipes.


Condition Intervention Phase
Hygiene
Drug: lactoserum
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability and Dermical Sensibility) of Dermacyd Wipes

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Score evaluation of the cutaneous reaction, preconized by International Contact Dermatitis Research Group (ICDRG)

Estimated Enrollment: 50
Study Start Date: May 2006
  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00371852

Locations
Brazil
Sanofi-aventis
São Paulo, Brazil
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Jaderson Lima Sanofi
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00371852     History of Changes
Other Study ID Numbers: LACTO_L_01811
Study First Received: August 31, 2006
Last Updated: May 15, 2008
Health Authority: Brazil: National Health Surveillance Agency

ClinicalTrials.gov processed this record on April 17, 2014