Topic Compatibility Lactoserum (Dermacyd Delicata - New Fragrance)

NCT ID: NCT00497692

Last Updated: 2008-05-20

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

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Brief Summary

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The purpose of this study is to demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd Femina Delicata.

Detailed Description

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Conditions

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Hygiene

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Interventions

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Lactoserum

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Phototypes: I, II, III and IV
* Integral skin test in the region

Exclusion Criteria

* Pregnancy or breastfeeding women
* Use of antinflammatory or immune-suppression drugs
* Personal history of atopy
* History of sensibilization or irritation for topic products
* Active cutaneous disease
* Use of new drugs and/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

Principal Investigators

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Jaderson Lima

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-aventis

São Paulo, , Brazil

Site Status

Countries

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Brazil

Other Identifiers

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LACTO_L_02948

Identifier Type: -

Identifier Source: org_study_id