Dermacyd Breeze Pocket BR (Lactic Acid) - Acceptability

Hygiene Clinical Trial

Official title:

Safety Dermatological Evaluation: Genital Mucous Irritation - Test in Use - Dermacyd Breeze Pocket BR (Lactic Acid).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00793026
• Other study ID #: LACAC_L_04365
• 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. 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

• Hygiene

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

External Links

•   Link