We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dermatological Evaluation of Topic Compatibility - Dermacyd Breeze

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00668577
First Posted: April 29, 2008
Last Update Posted: February 10, 2009
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 irritation potential (primary dermal irritability and cumulated dermal irritability) and allergy (sensibilization) of the product Dermacyd Pocket BR.

Condition Intervention Phase
Healthy Drug: Lactic acid (Dermacid) Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability, Dermical Sensitivity) of Dermacyd Breeze.

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • The absence of primary and accumulated dermal irritability and dermal sensitivity will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale. [ Time Frame: six weeks ]

Enrollment: 52
Study Start Date: December 2007
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
  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:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Use of Antiinflammatory and/or immunosuppression drugs
  • Personnel history of atopy
  • History of sensitivity or irritation for topic products
  • Active cutaneous disease
  • Use of new drugs 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
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): NCT00668577


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

Responsible Party: GMA-CO/Medical Director, sanofi-aventis administrative office France
ClinicalTrials.gov Identifier: NCT00668577     History of Changes
Other Study ID Numbers: LACAC_L_03747
First Submitted: April 23, 2008
First Posted: April 29, 2008
Last Update Posted: February 10, 2009
Last Verified: February 2009

Keywords provided by Sanofi:
Hygiene

Additional relevant MeSH terms:
Dermatologic Agents