NCT00497692

Brief Summary

The purpose of this study is to demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd Femina Delicata.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 9, 2007

Completed
Last Updated

May 20, 2008

Status Verified

May 1, 2008

First QC Date

July 6, 2007

Last Update Submit

May 19, 2008

Conditions

Hygiene

Outcome Measures

Primary Outcomes (1)

  • Score evaluation of the cutaneous reaction, preconized by International Contact Dermatitis Research Group (ICDRG)

    six weeks

Interventions

LactoserumDRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Phototypes: I, II, III and IV
  • Integral skin test in the region

You may not qualify if:

  • Pregnancy or breastfeeding women
  • Use of antinflammatory or immune-suppression drugs
  • Personal history of atopy
  • History of sensibilization or irritation for topic products
  • Active cutaneous disease
  • Use of new drugs and/or cosmetics during the study
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-aventis

São Paulo, Brazil

Location

MeSH Terms

Interventions

lactoserum

Study Officials

  • Jaderson Lima

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 6, 2007

First Posted

July 9, 2007

Study Start

May 1, 2007

Last Updated

May 20, 2008

Record last verified: 2008-05

Locations

BR(1)