Acceptability Lactoserum (Dermacyd Delicata - New Fragrance)

Hygiene Clinical Trial

Official title:

Safety Dermatological Evaluation of the Acceptability With Gynecological Follow up for Dermacyd Femina Delicata

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00497783
• Other study ID #: LACTO_L_02949
• Status: Completed
• Phase: Phase 4
• First received: July 6, 2007
• Last updated: May 19, 2008
• Start date: May 2007

Study information

• Verified date: May 2008
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Integral skin in the tested region

Exclusion Criteria:

• Pregnancy or breastfeeding women

• Use of Anti-inflammatory or immune-suppression drugs

• Topical medication use at the tested region

• Active cutaneous gynaecological disease which may interfere in study results

• Personal history of allergic disease at the area to be treated

• Allergic or atopic history

The above information is not intended to contain considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hygiene

Intervention

Drug:
• Lactoserum

Locations

Country	Name	City	State
Brazil	Sanofi-aventis	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical and local tolerability		21 days
Primary	Adverse events and their association with the treatment.		21 days