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

Hygiene Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01126606
• Other study ID #: LACAC_L_04937
• Status: Completed
• Phase: Phase 3
• First received: May 17, 2010
• Last updated: December 1, 2010
• Start date: August 2010
• Est. completion date: November 2010

Study information

• Verified date: December 2010
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hygiene

Intervention

Drug:
• Dermacid Silver (Lactic acid)
Liquid soap, daily use
• Glycerine Vegetal Soap Granado Traditional
Vegetal soap, daily use

Locations

Country	Name	City	State
Brazil	Sanofi-Aventis Administrative Office	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transepidermal water loss measurement (TEWL) and corneometry	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	No