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CompletedNCT01126606Updated Dec 2, 2010

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

A Phase 3 interventional study of Dermacid Silver (Lactic acid) and Glycerine Vegetal Soap Granado Traditional in Hygiene, sponsored by Sanofi. Completed at 1 site in Brazil. Open to female participants aged 45 Years to 65 Years. Per ClinicalTrials.gov, last updated 2010-12-02.

Sponsored by Sanofi · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
45 Years to 65 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Hygiene
03

In context

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
70 participants (actual)

Study arms

  • 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) · Drug: Glycerine Vegetal Soap Granado Traditional

  • 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) · Drug: Glycerine Vegetal Soap Granado Traditional

Interventions

  • DrugDermacid Silver (Lactic acid)

    Liquid soap, daily use

  • DrugGlycerine Vegetal Soap Granado Traditional

    Vegetal soap, daily use

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to Week 9

07

Study locations

1 site
  • Sanofi-Aventis Administrative Office
    Sao Paulo, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01126606
Lead sponsor
Sanofi
First posted
May 19, 2010
Start date
Aug 2010
Primary completion
Nov 2010
Completion
Nov 2010
Last update
Dec 2, 2010

Study contacts

Clinical Sciences & Operations
study director · Sanofi
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.

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