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Topic Compatibility Lactoserum (Dermacyd Delicata - New Fragrance)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00497692
First received: July 6, 2007
Last updated: May 19, 2008
Last verified: May 2008
History of Changes
  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 Femina Delicata.


Condition Intervention Phase
Hygiene
 Drug: Lactoserum
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability and Dermical Sensitivity) for Dermacyd Femina Delicata

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Score evaluation of the cutaneous reaction, preconized by International Contact Dermatitis Research Group (ICDRG) [ Time Frame: six weeks ]

Estimated Enrollment: 30
Study Start Date: May 2007
  Eligibility

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

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy or breastfeeding women
  • Use of antinflammatory or immune-suppression drugs
  • Personal history of atopy
  • History of sensibilization or irritation for topic products
  • Active cutaneous disease
  • Use of new drugs and/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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00497692

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: NCT00497692     History of Changes
Other Study ID Numbers: LACTO_L_02948
Study First Received: July 6, 2007
Last Updated: May 19, 2008
Health Authority: Brazil: National Health Surveillance Agency

ClinicalTrials.gov processed this record on May 16, 2013