Acceptability of Lactacyd Femina

Phase 4

Completed

• Conditions: Hygiene
• Interventions: Drug: Lactic acid

• Registration Number: NCT00712868
• Lead Sponsor: Sanofi

Brief Summary

To demonstrate the safety and acceptability of the gynaecological formulation.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-07-07
• Study First Submitted QC: 2008-07-09
• Study First Posted: 2008-07-10
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-17
• Last Update Posted: 2009-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 559

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Lactic acid	Lactic Acid once a day during 21 days

Primary Outcome Measures

Name	Time	Method
Clinical and local tolerability	After 21 days

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇲🇽 Col. Coyoacan, Mexico