Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd Breeze

NCT ID: NCT00664391

Last Updated: 2009-02-10

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

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Brief Summary

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

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

Group Type EXPERIMENTAL

Lactic acid (Dermacid)

Intervention Type DRUG

Liquid soup to be applied in the external genital area, in small quantity, with abundantly rinse after use, during 21 days

Interventions

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Lactic acid (Dermacid)

Liquid soup to be applied in the external genital area, in small quantity, with abundantly rinse after use, during 21 days

Intervention Type DRUG

Eligibility Criteria

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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.
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 administrative office France

Principal Investigators

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Jaderson Lima

Role: STUDY_DIRECTOR

Sanofi-aventis administrative office Brazil

Locations

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Sanofi-aventis

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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LACAC_L_03746

Identifier Type: -

Identifier Source: org_study_id

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