Safety Dermatological Evaluation: Acceptability With Gyne... | NCT00663325

Studies
Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd Tina Gel Sweet Flower

NCT00663325

Sponsor

Sanofi

Status

Completed

Last Update Posted

Jan 8, 2009Estimated

Enrollment

30Actual

Phase

Phase 3

Conditions

Hygiene

Interventions

Lactic acid (Dermacid)

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

Jan 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

Dec 2007

Primary Completion Date

Jan 2008Actual

Completion Date

Not provided

First Submitted Date

Apr 18, 2008

First Submission Date that Met QC Criteria

Apr 21, 2008

First Posted Date

Apr 22, 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

Jan 7, 2009

Last Update Posted Date

Jan 8, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to demonstrate the safety of the gynecological formulation in normal and usual usage condition of Dermacyd Tina Gel Sweet Flower.

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Lactic acid in small quantity during 21 days	Drug: Lactic acid (Dermacid)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lactic acid (Dermacid)	Drug	Liquid soup to be applied in the external genital area, in a small quantity, with abundantly rinse after use, during 21 days.	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse events and their intensity and their association with the treatment		21 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Integral skin test in the region;

Exclusion Criteria:

Lactation or gestational risk or gestation;
Use of Anti-inflammatory or immunosuppression drugs 1 month before the study;
Topical medication use at the region to be treated;
Cutaneous disease or active gynecological 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

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-aventis administrative office Brazil	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sanofi-aventis		São Paulo	São Paulo		Brazil

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