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OpenTrials
Completed

NCT Number: NCT00712868

Acceptability of Lactacyd Femina

To demonstrate the safety and acceptability of the gynaecological formulation.

Completed

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-Aventis Administrative Office

Col. Coyoacan, Mexico

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lactic acid

Drug

Once a day

Primary outcomes

  1. Clinical and local tolerability

    Time frame: After 21 days

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Safety Dermatological Evaluation: Acceptability With Gynaecological Follow up Lactacyd Femina

Acronym: LACTAFEM

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jul 10, 2008
Registry last updated
Jul 20, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.