Dermacyd PH_DETINLYN Sweet Flower (Lactic Acid) - Safety | NCT00785148

Studies
Dermacyd PH_DETINLYN Sweet Flower (Lactic Acid) - Safety

NCT00785148

Sponsor

Sanofi

Status

Completed

Last Update Posted

Mar 6, 2009Estimated

Enrollment

31Actual

Phase

Phase 3

Conditions

Hygiene

Interventions

Dermacyd PH_DETINLYN Sweet Flower (Lactic Acid)

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

Mar 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

Aug 2008

Primary Completion Date

Sep 2008Actual

Completion Date

Not provided

First Submitted Date

Nov 4, 2008

First Submission Date that Met QC Criteria

Nov 4, 2008

First Posted Date

Nov 5, 2008Estimated

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

Mar 5, 2009

Last Update Posted Date

Mar 6, 2009Estimated

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 3

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
1	Experimental	Dermacyd PH_DETINLYN Sweet Flower (Lactic Acid)	Drug: Dermacyd PH_DETINLYN Sweet Flower (Lactic Acid)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dermacyd PH_DETINLYN Sweet Flower (Lactic Acid)	Drug		1

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 treatment start to the end of study

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Integral skin test in the region,
Use of cosmetic product of the same category

Exclusion Criteria:

Lactation or gestational risk or gestation
Use of Anti-inflammatory, immunosuppression or anti-histaminic drugs
Atopic antecedent or allergic to cosmetic product
Active cutaneous disease in the evaluation area
Diseases which cause immunology decrease, such as diabetes and HIV
Endocrinal pathologies
Intense solar exposure 15 days before the evaluation
Treatment until four months before the 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

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

20 Years

Standard Ages

ChildAdult

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

Label	URL
Related Info	View source

Intervention Browse Module

MeSH Terms

ID	Term
D019344	Lactic Acid

Ancestor Terms

ID	Term
D007773	Lactates
D006880	Hydroxy Acids
D002264	Carboxylic Acids
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided