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Topic Compatibility Dermacyd Wipes - Lactoserum - Hygiene

This study has been completed.
Information provided by:
Sanofi Identifier:
First received: August 31, 2006
Last updated: May 15, 2008
Last verified: May 2008
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
Intervention Model: Single Group Assignment
Masking: None (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

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT00371852

São Paulo, Brazil
Sponsors and Collaborators
Study Director: Jaderson Lima Sanofi
  More Information Identifier: NCT00371852     History of Changes
Other Study ID Numbers: LACTO_L_01811
Study First Received: August 31, 2006
Last Updated: May 15, 2008 processed this record on August 23, 2017