Acceptability Dermacyd Wipes - Lactoserum - Hygiene

Hygiene Clinical Trial

Official title:

Safety Dermatological Evaluation: Acceptability With Gynecological Follow up of Dermacyd Wipes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00397527
• Other study ID #: LACTO_L_01810
• Status: Completed
• Phase: Phase 3
• First received: November 8, 2006
• Last updated: May 15, 2008
• Start date: July 2006

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 Wipes

Recruitment information / eligibility

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

Eligibility

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:

• Integral skin in the tested region

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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	Adverse events and their association with the treatment.