Comparative Safety and Efficacy Evaluation Between Dermacyd Silver and Glycerine Vegetal Soap Granado Traditional

December 1, 2010 updated by: Sanofi

Single Center, Open, Cross-over, Phase III Study for Safety and Efficacy (Subjective and Instrumental) Comparative Evaluation Between Dermacyd Silver and Glycerine Vegetal Soap Granado Traditional for Intimate Use in Menopauses Woman.

Primary Objective:

To evaluate the potential of hydratation and renewal of the mucosa, through corneometry measurement and individual questionnaire perception.

Secondary Objective:

To evaluate the safety in normal condition of use.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil
        • Sanofi-Aventis Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion criteria:

  • Active sex life
  • Menopause for at least 6 months
  • Perfect mucosa in the evaluated area
  • Use the same cosmetics category

Exclusion criteria:

  • Use of antiinflammatory / immunosuppression / antihistaminic drugs
  • Personal history of atopy to cosmetic products
  • Cutaneous active disease (local and/or general) in the evaluated area
  • Disease which can cause immunosuppression, such as diabetes, HIV
  • Endocrine pathology such as thyroid disease, ovarian disorder or adrenal gland
  • Intense solar exposure (to get a tan) during the 15 days before the evaluation
  • Gynaecologic treatment until four weeks before the evaluation
  • Whatever vaginal infection detected at time of inclusion
  • Other conditions considered by the investigator as reasonable to exclude the patient from the study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
Dermacyd Silver Frutal followed by Dermacyd Silver Frutal+PH_DESYLSTY_FR followed by wash out followed by Glycerine Vegetal Soap Granado Traditional
Drug: Dermacid Silver (Lactic acid)
Liquid soap, daily use
Drug: Glycerine Vegetal Soap Granado Traditional
Vegetal soap, daily use
Experimental: Group 2
Glycerine Vegetal Soap Granado Traditional followed by wash out followed by Dermacyd Silver Floral followed by Dermacyd Silver Floral + PH_DESYLSTY_FR
Drug: Dermacid Silver (Lactic acid)
Liquid soap, daily use
Drug: Glycerine Vegetal Soap Granado Traditional
Vegetal soap, daily use

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transepidermal water loss measurement (TEWL) and corneometry
Time Frame: Up to Week 9

Measures taken at all visits by Tewameter equipment TM 300. The value of the average will be considered for analysis of final results.

Corneometry: Measures taken at all visits by Corneometer equipment MPA 580.
Up to Week 9

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

May 17, 2010

First Submitted That Met QC Criteria

May 18, 2010

First Posted (Estimate)

May 19, 2010

Study Record Updates

Last Update Posted (Estimate)

December 2, 2010

Last Update Submitted That Met QC Criteria

December 1, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LACAC_L_04937

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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