Dermacyd Infantile (Lactic Acid)- Compatibility. | NCT00881374

Studies
Dermacyd Infantile (Lactic Acid)- Compatibility.

NCT00881374

Sponsor

Sanofi

Status

Completed

Last Update Posted

Apr 15, 2009Estimated

Enrollment

50Actual

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

Apr 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

Feb 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

Apr 14, 2009

Last Update Posted Date

Apr 15, 2009Estimated

Description Module

Brief Summary

Primary Objective:

To demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergic potential (sensibilization) of the product Dermacyd Infantile.

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

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dermacyd Infantile (Lactic Acid)	Experimental	six weeks treatment	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 primary and accumulated dermic irritability and dermic sensitivity will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale.		During 6 weeks (i.e. treatment period)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Photo type Skin I,II, III e IV
Integral skin test in the region
Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion.

Exclusion criteria:

Lactation or gestation
Use of Anti-inflammatory 30 days and/or immunosuppressant drugs during 3 months before the selection
Diseases which can cause immunity decrease, such as HIV, diabetes
Previous atopy
History of sensitivity or irritation for topic products
Active cutaneous diseases which can interfere in the study results
Use of new drugs and/ or cosmetics during the study
Cutaneous reactivity
Previous participation in studies, which had used the product
Volunteers who have immunodeficiency congenital or acquired
Relevant clinical history or present evidence of alcohol abuse or others drugs
Non tolerance to some component of the study product.

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

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided