Dermacyd Infantile - Acceptability.

Hygiene Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00881270
• Other study ID #: LACAC_L_04678
• Status: Completed
• Phase: Phase 4
• First received: April 10, 2009
• Last updated: September 25, 2009
• Start date: March 2009
• Est. completion date: March 2009

Study information

• Verified date: September 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

Primary Objective:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 12 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hygiene

Intervention

Drug:
• LACTIC ACID(ND)
Dermacyd Infantile (LACTIC ACID)

Locations

Country	Name	City	State
Brazil	Sanofi-Aventis Administrative Office	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No