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Dermacyd Infantile - Acceptability.

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00881270
First received: April 10, 2009
Last updated: September 25, 2009
Last verified: September 2009
History of Changes
  Purpose

Primary Objective:

To prove the safety of the formulation in normal conditions of use.


Condition Intervention Phase
Hygiene
 Drug: LACTIC ACID(ND)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Safety Dermatological Evaluation: Acceptability With Paediatric Follow up Dermacyd Infantile (Lactic Acid).

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • The absence of irritation and the good acceptability will be evaluated using one specific scale which describes the intensity of the reaction. [ Time Frame: From the treatment start to the end of the study ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: March 2009
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dermacyd infantile (Lactic Acid)
treatment duration 21 consecutive days
 Drug: LACTIC ACID(ND)
Dermacyd Infantile (LACTIC ACID)

  Eligibility

Ages Eligible for Study:   up to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Integral skin test in the region
  • Use the same category of cosmetics
  • Willingness in following the study procedures and to be present in the clinic at the days and scheduled time.

Exclusion criteria:

  • Use of Anti-inflammatory, immunosuppressant or anti-histaminic drugs
  • Allergic or atopic history to cosmetics products
  • Cutaneous active disease (local or general) in the evaluated area
  • Disease which can cause immunosuppressant, such as diabetes, HIV
  • Endocrine pathology
  • Intensive solar exposure until 15 days before evaluation
  • Treatment four months before selection.

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: NCT00881270

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: NCT00881270     History of Changes
Other Study ID Numbers: LACAC_L_04678
Study First Received: April 10, 2009
Last Updated: September 25, 2009
Health Authority: Brazil: National Health Surveillance Agency

ClinicalTrials.gov processed this record on May 16, 2013