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Topic Compatibility Dermacyd Wipes - Lactoserum - Hygiene

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ClinicalTrials.gov Identifier: NCT00371852
Recruitment Status : Completed
First Posted : September 4, 2006
Last Update Posted : May 16, 2008
Sponsor:
Information provided by:
Sanofi

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.

Condition or disease Intervention/treatment Phase
Hygiene Drug: lactoserum Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
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
Study Start Date : May 2006



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


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

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): NCT00371852


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

ClinicalTrials.gov Identifier: NCT00371852     History of Changes
Other Study ID Numbers: LACTO_L_01811
First Posted: September 4, 2006    Key Record Dates
Last Update Posted: May 16, 2008
Last Verified: May 2008