CClinicalTrials.gg
CompletedNCT00397527Updated May 16, 2008

Acceptability Dermacyd Wipes - Lactoserum - Hygiene

A Phase 3 interventional study of lactoserum in Hygiene, sponsored by Sanofi. Completed at 1 site in Brazil. Open to female participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-05-16.

Sponsored by Sanofi · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years to 60 Years
Sex
Female
01

Study summary

The purpose of this study is to demonstrate the safety of the gynecological formulation in normal and usual usage condition of Dermacyd Wipes

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
18 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.

Main criteria are listed hereafter:

Inclusion criteria

Inclusion Criteria:

  • Integral skin in the tested region

Exclusion criteria

Exclusion Criteria:

  • Pregnancy or breastfeeding women;
  • Use of antiinflammatory or immunosuppression drugs;
  • Topical medication use at the region to be treated;
  • Cutaneous disease or active gynaecological disease which may interfer in study results;
  • Personal history of allergic disease at the area to be treated;
  • Allergic or atopic history.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants

Interventions

  • Druglactoserum
06

What researchers measure

Primary outcomes

  1. Adverse events and their association with the treatment.

07

Study locations

1 site
  • Sanofi-Aventis
    São Paulo, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00397527
Lead sponsor
Sanofi
First posted
Nov 9, 2006
Start date
Jul 2006
Last update
May 16, 2008

Study contacts

Jaderson Lima
study director · Sanofi
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2008. You cannot join it, but the record below documents what was studied.

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