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OpenTrials
Completed

NCT Number: NCT01126606

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

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.

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Key information

Conditions

Hygiene

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi-Aventis Administrative Office

São Paulo, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dermacid Silver (Lactic acid)

Drug

Liquid soap, daily use

Glycerine Vegetal Soap Granado Traditional

Drug

Vegetal soap, daily use

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

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.

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 19, 2010
Registry last updated
Dec 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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