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Dermacyd Infantile - Acceptability.

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.
ClinicalTrials.gov Identifier: NCT00881270
Recruitment Status : Completed
First Posted : April 15, 2009
Last Update Posted : September 28, 2009
Sponsor:
Information provided by:
Sanofi

Brief Summary:

Primary Objective:

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


Condition or disease Intervention/treatment Phase
Hygiene Drug: LACTIC ACID(ND) Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Safety Dermatological Evaluation: Acceptability With Paediatric Follow up Dermacyd Infantile (Lactic Acid).
Study Start Date : March 2009
Primary Completion Date : March 2009
Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Dermacyd infantile (Lactic Acid)
treatment duration 21 consecutive days
Drug: LACTIC ACID(ND)
Dermacyd Infantile (LACTIC ACID)



Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 12 Years   (Child)
Sexes Eligible for Study:   All
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.


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): NCT00881270


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

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00881270     History of Changes
Other Study ID Numbers: LACAC_L_04678
First Posted: April 15, 2009    Key Record Dates
Last Update Posted: September 28, 2009
Last Verified: September 2009