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
  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:


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
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, see Learn About Clinical Studies.

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 July 20, 2014