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

Phase 3

Completed

• Conditions: Hygiene
• Interventions: Drug: Dermacid Silver (Lactic acid); Drug: Glycerine Vegetal Soap Granado Traditional

• Registration Number: NCT01126606
• Lead Sponsor: Sanofi

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-05-17
• Study First Submitted QC: 2010-05-18
• Study First Posted: 2010-05-19
• Study Start: 2010-08
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-01
• Last Update Posted: 2010-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 2	Glycerine Vegetal Soap Granado Traditional	Glycerine Vegetal Soap Granado Traditional followed by wash out followed by Dermacyd Silver Floral followed by Dermacyd Silver Floral + PH_DESYLSTY_FR
Group 1	Glycerine Vegetal Soap Granado Traditional	Dermacyd Silver Frutal followed by Dermacyd Silver Frutal+PH_DESYLSTY_FR followed by wash out followed by Glycerine Vegetal Soap Granado Traditional
Group 2	Dermacid Silver (Lactic acid)	Glycerine Vegetal Soap Granado Traditional followed by wash out followed by Dermacyd Silver Floral followed by Dermacyd Silver Floral + PH_DESYLSTY_FR
Group 1	Dermacid Silver (Lactic acid)	Dermacyd Silver Frutal followed by Dermacyd Silver Frutal+PH_DESYLSTY_FR followed by wash out followed by Glycerine Vegetal Soap Granado Traditional

Primary Outcome Measures

Name	Time	Method
Transepidermal water loss measurement (TEWL) and corneometry	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.

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇧🇷 Sao Paulo, Brazil