NCT00881270

Brief Summary

Primary Objective: To prove the safety of the formulation in normal conditions of use.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 10, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 15, 2009

Completed
Last Updated

September 28, 2009

Status Verified

September 1, 2009

Enrollment Period

Same day

First QC Date

April 10, 2009

Last Update Submit

September 25, 2009

Conditions

Hygiene

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Dermacyd infantile (Lactic Acid)

EXPERIMENTAL

treatment duration 21 consecutive days

Drug: LACTIC ACID(ND)

Interventions

LACTIC ACID(ND)DRUG

Dermacyd Infantile (LACTIC ACID)

Dermacyd infantile (Lactic Acid)

Eligibility Criteria

AgeUp to 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis Administrative Office

São Paulo, Brazil

Location

Study Officials

  • Jaderson Lima

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 10, 2009

First Posted

April 15, 2009

Study Start

March 1, 2009

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

September 28, 2009

Record last verified: 2009-09

Locations

BR(1)