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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00793026
Other study ID # LACAC_L_04365
Secondary ID
Status Completed
Phase Phase 3
First received November 17, 2008
Last updated December 18, 2008
Start date November 2008

Study information

Verified date December 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 prove the safety of the gynaecological formulation in normal conditions of use.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date
Est. primary completion date November 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 60 Years
Eligibility Inclusion criteria:

- Integral skin test in the region;

- To use products of the same category;

Exclusion criteria:

- Lactation or gestation;

- Use of anti-inflammatory, anti-histaminic or immunosuppressant drugs;

- Cutaneous disease (local or spread) in the evaluation area;

- Pathology which may cause immunity depression, such as HIV, diabetes;

- Endocrine pathology

- Solar exposure 15 days before evaluation;

- Treatment until four months before the selection.

- Allergic or atopic history to cosmetics products

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/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Drug:
Dermacyd Breeze Pocket BR (Lactic Acid)
Dermacyd Breeze Pocket BR (Lactic Acid) during 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 Absence of irritation Throughout the study No
Primary Good acceptability Throughout the study No
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