Acceptability of Lactacyd Femina

Hygiene Clinical Trial

— LACTAFEM  

Official title:

Safety Dermatological Evaluation: Acceptability With Gynaecological Follow up Lactacyd Femina

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00712868
• Other study ID #: LACAC_L_03447
• Status: Completed
• Phase: Phase 4
• First received: July 7, 2008
• Last updated: July 17, 2009
• Start date: June 2008
• Est. completion date: August 2008

Study information

• Verified date: July 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

To demonstrate the safety and acceptability of the gynaecological formulation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 559
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• 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 all 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: Treatment

Related Conditions & MeSH terms

• Hygiene

Intervention

Drug:
• Lactic acid
Once a day

Locations

Country	Name	City	State
Mexico	Sanofi-Aventis Administrative Office	Col. Coyoacan

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical and local tolerability		After 21 days	No