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Dermacyd Silver Floral (Lactic Acid) - Acceptability.

NCT ID: NCT00933569

Last Updated: 2010-09-14

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

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2009-07-31

Brief Summary

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Primary Objective:

To prove the safety of the gynaecological formulation in normal conditions of use.

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

PREVENTION

Blinding Strategy

NONE

Study Groups

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Dermacyd Silver Floral (Lactic Acid)

Aplication of Dermacyd Silver Floral (Lactic Acid) during 21 consecutive days

Group Type EXPERIMENTAL

LACTIC ACID(ND)

Intervention Type DRUG

treatment period: 21 consecutive days

Interventions

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LACTIC ACID(ND)

treatment period: 21 consecutive days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Integral vaginal mucosa in the product analysis region
* Use the same category of cosmetics products
* Willingness in following the study procedures and to be present in the clinic at the days and scheduled time

Exclusion Criteria

* Use of Anti-inflammatory, immunossupression or antihistaminics drugs
* Allergic or atopic history to cosmetics products
* Cutaneous active disease (local and/or general) in the evaluated area
* Disease which can cause immunosuppresion, such as diabetes, HIV
* Endocrinology pathology such as thyroid gland, ovary and adrenal gland
* Intensive solar exposure until 15 days before evaluation
* Gynecological treatment until four weeks before the study
* Other reason considered by the investigator as a reason for not being included.

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

65 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

Other Identifiers

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LACAC_L_04838

Identifier Type: -

Identifier Source: org_study_id