Dermacyd Femina (Lactic Acid) Pocket BR - Photo Evaluation | NCT00783640

Studies
Dermacyd Femina (Lactic Acid) Pocket BR - Photo Evaluation

NCT00783640

Sponsor

Sanofi

Status

Completed

Last Update Posted

Dec 19, 2008Estimated

Enrollment

27Actual

Phase

Phase 3

Conditions

Hygiene

Interventions

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

Dec 2008

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

Oct 2008

Primary Completion Date

Nov 2008Actual

Completion Date

Not provided

First Submitted Date

Oct 31, 2008

First Submission Date that Met QC Criteria

Oct 31, 2008

First Posted Date

Nov 3, 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

Dec 18, 2008

Last Update Posted Date

Dec 19, 2008Estimated

Description Module

Brief Summary

To demonstrate the absence of photoirritation and photosensitization potential of the product Dermacyd Femina (Lactic Acid) Pocket BR.

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

27Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Lactic Acid	Drug: Lactic Acid

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lactic Acid	Drug	Drug: Lactic Acid (Dermacyd Femina)	1

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.		Throughout the study
The sensibility will be evaluated according to the skin type.		Throughout the study

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Age between 18 and 60 years old;
Phototype 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 Antiinflammatory and/or immunosuppression drugs one month before the study;
Personnel history of atopy;
History of sensitivity or irritation for topic products;
Active cutaneous disease;
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

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

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Browse Branches

Not provided