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Topic Compatibility Lactoserum (Dermacyd Delicata - New Fragrance)

This study has been completed.
Information provided by:
Sanofi Identifier:
First received: July 6, 2007
Last updated: May 19, 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 Femina Delicata.

Condition Intervention Phase
Hygiene Drug: Lactoserum Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00497692

São Paulo, Brazil
Sponsors and Collaborators
Study Director: Jaderson Lima Sanofi
  More Information Identifier: NCT00497692     History of Changes
Other Study ID Numbers: LACTO_L_02948
Study First Received: July 6, 2007
Last Updated: May 19, 2008 processed this record on September 21, 2017