Acceptability of Lactacyd Femina | NCT00712868

Studies
Acceptability of Lactacyd Femina

NCT00712868

Sponsor

Sanofi

Status

Completed

Last Update Posted

Jul 20, 2009Estimated

Enrollment

559Actual

Phase

Phase 4

Conditions

Hygiene

Interventions

Lactic acid

Countries

Mexico

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

Jul 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

Jun 2008

Primary Completion Date

Aug 2008Actual

Completion Date

Aug 2008Actual

First Submitted Date

Jul 7, 2008

First Submission Date that Met QC Criteria

Jul 9, 2008

First Posted Date

Jul 10, 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

Jul 17, 2009

Last Update Posted Date

Jul 20, 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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

559Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Lactic Acid once a day during 21 days	Drug: Lactic acid

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lactic acid	Drug	Once a day	1

Measure	Description	Time Frame
Clinical and local tolerability		After 21 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Integral skin in the tested region

Exclusion Criteria:

Pregnancy or breastfeeding women
Use of anti-inflammatory or immune-suppression drugs
Topical medication use at the tested region
Active cutaneous gynaecological disease which may interfere in study results
Personal history of allergic disease at the area to be treated
Allergic or atopic history

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

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Judith Diaz, Md	Sanofi	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sanofi-Aventis Administrative Office		Col. Coyoacan			Mexico

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