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Clinical Trials/NCT00712868
NCT00712868CompletedPhase 4

Safety Dermatological Evaluation: Acceptability With Gynaecological Follow up Lactacyd Femina

Sanofi1 site in 1 country559 target enrollmentStarted: June 2008Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Sanofi
Enrollment
559
Locations
1
Primary Endpoint
Clinical and local tolerability

Study Overview

Brief Summary

To demonstrate the safety and acceptability of the gynaecological formulation.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

1

Experimental

Lactic Acid once a day during 21 days

Intervention: Lactic acid (Drug)

Outcomes

Primary Outcomes

Clinical and local tolerability

Time Frame: After 21 days

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Sanofi
Sponsor Class
Industry

Study Sites (1)

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