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Dermacyd Femina (Lactic Acid) Pocket BR - Compatibility

NCT ID: NCT00783861

Last Updated: 2008-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Brief Summary

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To demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd Femina (Lactic Acid) Pocket BR.

Detailed Description

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Conditions

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Hygiene

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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1

Lactic Acid (Dermacyd Femina)

Group Type EXPERIMENTAL

Lactic Acid

Intervention Type DRUG

Lactic Acid (Dermacyd Femina)

Interventions

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Lactic Acid

Lactic Acid (Dermacyd Femina)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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sanofi-aventis

Principal Investigators

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Jaderson Lima

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis Administrative Office

São Paulo, , Brazil

Site Status

Countries

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Brazil

Related Links

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http://www.sanofi-aventis.com

Related Info

Other Identifiers

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LACAC_L_04370

Identifier Type: -

Identifier Source: org_study_id