Dermacyd Infantile - Acceptability. | NCT00881270

Studies
Dermacyd Infantile - Acceptability.

NCT00881270

Sponsor

Sanofi

Status

Completed

Last Update Posted

Sep 28, 2009Estimated

Enrollment

31Actual

Phase

Phase 4

Conditions

Hygiene

Interventions

LACTIC ACID(ND)

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Mar 2009Actual

Completion Date

Mar 2009Actual

First Submitted Date

Apr 10, 2009

First Submission Date that Met QC Criteria

Apr 14, 2009

First Posted Date

Apr 15, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 25, 2009

Last Update Posted Date

Sep 28, 2009Estimated

Description Module

Brief Summary

Primary Objective:

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

31Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dermacyd infantile (Lactic Acid)	Experimental	treatment duration 21 consecutive days	Drug: LACTIC ACID(ND)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LACTIC ACID(ND)	Drug	Dermacyd Infantile (LACTIC ACID)	Dermacyd infantile (Lactic Acid)

Outcomes Module

Primary Outcomes

Measure	Description	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jaderson Lima	Sanofi	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sanofi-Aventis Administrative Office		São Paulo			Brazil