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Dermatological Evaluation of Topic Compatibility - Dermacyd Breeze

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00668577
First received: April 23, 2008
Last updated: February 9, 2009
Last verified: February 2009
History of Changes
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Enrollment: 52
Study Start Date: December 2007
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: April 23, 2008
Last Updated: February 9, 2009
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Sanofi:
Hygiene

ClinicalTrials.gov processed this record on May 19, 2013