Dermacyd Femina (Lactic Acid) - Photo Dermatological Eval... | NCT00705744

Studies
Dermacyd Femina (Lactic Acid) - Photo Dermatological Evaluation of the Irritation and Sensitivity Potential.

NCT00705744

Sponsor

Sanofi

Status

Completed

Last Update Posted

Apr 15, 2009Estimated

Enrollment

26Actual

Phase

Phase 3

Conditions

Hygiene

Interventions

Lactic acid (Dermacyd Femina)

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

Apr 2008

Primary Completion Date

May 2008Actual

Completion Date

Not provided

First Submitted Date

Jun 25, 2008

First Submission Date that Met QC Criteria

Jun 25, 2008

First Posted Date

Jun 26, 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

Apr 14, 2009

Last Update Posted Date

Apr 15, 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

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

26Actual

Label	Type	Description	Intervention Names
I	Experimental		Drug: Lactic acid (Dermacyd Femina)

Name	Type	Description	Arm Group Labels	Other Names
Lactic acid (Dermacyd Femina)	Drug		I

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The photo irritation test and the photosensitivity will be measured using UVA irradiation and evaluated according International Contact Dermatitis Research Group (ICDRG) scale		5 weeks
The sensibility will be evaluated according to the skin type.		5 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Phototype Skin II and III;
Integral skin test in the region;

Exclusion Criteria:

Lactation or gestation;
Use of Anti-inflammatory and/or immuno-suppression drugs 15 days before the selection;
Diseases which can cause immunity decrease, such as HIV, diabetes;
Use of drug photosensitizer;
History of sensitivity or irritation for topic products;
Active cutaneous disease which can change the study results;
History or photodermatosis active;
Family or personal antecedent of cutaneous photoinduced neoplasias;
Presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and keratoses actinium;
Intense solar exposure in the study area;
Use of new drugs or cosmetics during the study;

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

Name	Affiliation	Role
Jaderson Lima, MD	Sanofi	Study Director

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