Acceptability of Lactacyd Femina
LACTAFEM
Safety Dermatological Evaluation: Acceptability With Gynaecological Follow up Lactacyd Femina
1 other identifier
interventional
559
1 country
1
Brief Summary
To demonstrate the safety and acceptability of the gynaecological formulation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2008
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 7, 2008
CompletedFirst Posted
Study publicly available on registry
July 10, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedJuly 20, 2009
July 1, 2009
2 months
July 7, 2008
July 17, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical and local tolerability
After 21 days
Study Arms (1)
1
EXPERIMENTALLactic Acid once a day during 21 days
Interventions
Eligibility Criteria
You may qualify if:
- Integral skin in the tested region
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (1)
Sanofi-Aventis Administrative Office
Col. Coyoacan, Mexico
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Judith Diaz, Md
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 7, 2008
First Posted
July 10, 2008
Study Start
June 1, 2008
Primary Completion
August 1, 2008
Study Completion
August 1, 2008
Last Updated
July 20, 2009
Record last verified: 2009-07