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Dermacyd Teen Care Tangerina Mix - Compatibility

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00761800
First received: September 29, 2008
Last updated: May 28, 2009
Last verified: May 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 Teen Care Tangerina Mix.


Condition Intervention Phase
Hygiene
 Drug: Lactic acid
 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 Dermal Irritability, Dermal Sensitivity) of Dermacyd Teen Care Tangerina Mix .

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 will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale. [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]

Enrollment: 51
Study Start Date: May 2008
Study Completion Date: May 2008
Primary Completion Date: May 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:

  • Lactation or gestation
  • Use of Anti-inflammatory and/or immuno-Supression drugs 1 month before the study
  • Personal 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: NCT00761800

Locations
Brazil
Sanofi-Aventis Administrative Office
Sao Paulo, Brazil
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Jaderson Lima Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study director, Sanofi-aventis
ClinicalTrials.gov Identifier: NCT00761800     History of Changes
Other Study ID Numbers: LACAC_L_04087
Study First Received: September 29, 2008
Last Updated: May 28, 2009
Health Authority: Brazil: National Health Surveillance Agency

ClinicalTrials.gov processed this record on May 19, 2013