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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00497783
Other study ID # LACTO_L_02949
Secondary ID
Status Completed
Phase Phase 4
First received July 6, 2007
Last updated May 19, 2008
Start date May 2007

Study information

Verified date May 2008
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority Brazil: National Health Surveillance Agency
Study type Interventional

Clinical Trial Summary

The purpose of this study is to demonstrate the safety of the gynecological formulation in normal and usual usage condition of Dermacyd Femina Delicata.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 60 Years
Eligibility 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 considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Drug:
Lactoserum


Locations

Country Name City State
Brazil Sanofi-aventis São Paulo

Sponsors (1)

Lead Sponsor Collaborator
Sanofi

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical and local tolerability 21 days
Primary Adverse events and their association with the treatment. 21 days
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