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Topic Compatibility Dermacyd Delicata - New Fragrance - Lactoserum - Hygiene

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00380991
First Posted: September 27, 2006
Last Update Posted: May 16, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sanofi
  Purpose
The purpose of this study is to demonstrate the absence of potential irritation (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd Delicata (new fragrance of Dermacyd)

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: Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability and Dermical Sensitivity) of Dermacyd Delicata (New Fragrance)

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Phototype Skin I,II, III and IV
  • Integral skin test in the region;

Exclusion Criteria:

  • Lactation or gestation
  • Use of Antiinflammatory and/or immunosuppression drugs
  • Personal history of atopy;
  • History of sensibilization or irritation for topic products;
  • Active cutaneous disease;
  • Use of new drugs or cosmetics during the study
  Contacts and Locations
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): NCT00380991


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

ClinicalTrials.gov Identifier: NCT00380991     History of Changes
Other Study ID Numbers: LACTO_L_01840
First Submitted: September 25, 2006
First Posted: September 27, 2006
Last Update Posted: May 16, 2008
Last Verified: May 2008