Dermacyd Infantile - Acceptability.

Safety Dermatological Evaluation: Acceptability With Paediatric Follow up Dermacyd Infantile (Lactic Acid).

Primary Objective:

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

Study Overview

• Status: Completed
• Conditions: Hygiene
• Intervention / Treatment: Drug: LACTIC ACID(ND)

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil
    • Sanofi-Aventis Administrative Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 12 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The absence of irritation and the good acceptability will be evaluated using one specific scale which describes the intensity of the reaction.	From the treatment start to the end of the study

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: April 10, 2009
• First Submitted That Met QC Criteria: April 14, 2009
• First Posted (Estimate): April 15, 2009

Study Record Updates

• Last Update Posted (Estimate): September 28, 2009
• Last Update Submitted That Met QC Criteria: September 25, 2009
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Other Study ID Numbers: LACAC_L_04678