Acceptability of Lactacyd Femina (LACTAFEM)

Sanofi

Status and phase: Completed; Phase 4

Conditions: Hygiene

Treatments: Drug: Lactic acid

Study type: Interventional

Funder types: Industry

Identifiers

NCT00712868

LACAC_L_03447

Details and patient eligibility

About

To demonstrate the safety and acceptability of the gynaecological formulation.

Enrollment: 559 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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559 participants in 1 patient group

1

Experimental group

Description:

Lactic Acid once a day during 21 days

Treatment:

Drug: Lactic acid