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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00933699
Other study ID # LACAC_L_04803
Secondary ID
Status Completed
Phase Phase 3
First received July 3, 2009
Last updated September 13, 2010
Start date June 2009
Est. completion date July 2009

Study information

Verified date September 2010
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority Brazil: National Health Surveillance Agency
Study type Interventional

Clinical Trial Summary

Primary Objective:

To prove the safety of the gynaecological formulation in normal conditions of use.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date July 2009
Est. primary completion date July 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 65 Years
Eligibility Inclusion criteria:

- Integral vaginal mucosa in the product analysis region

- Use the same category cosmetics products

- Willingness in following the study procedures and to be present in the clinic at the days and scheduled time;

Exclusion criteria:

- Use of Anti-inflammatory, immunossupression or antihistaminics drugs

- Allergic or atopic history to cosmetics products

- Cutaneous active disease (local and/or general) in the evaluated area

- Disease which can cause immunosuppresion, such as diabetes, HIV

- Endocrinology pathology such as thyroid gland, ovary and adrenal gland

- Intensive solar exposure until 15 days before evaluation

- Gynecological treatment until four weeks before the study

- Other reason considered by the investigator as a reason for not being included.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
LACTIC ACID(ND)
Treatment duration: 21 consecutive days

Locations

Country Name City State
Brazil Sanofi-Aventis Administrative Office Sao Paulo

Sponsors (1)

Lead Sponsor Collaborator
Sanofi

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary The absence of irritation and the good acceptability will be evaluated using one specific scale which describes the intensity of the reaction. From the treatment start to the end of the study (treatment period 21 days) No
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