Dermacyd Femina Pocket BR (Lactic Acid)- Acceptability.

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

The purpose of this study is to prove the safety of the gynaecological formulation in normal conditions of use.

Study Overview

• Status: Completed
• Conditions: Hygiene
• Intervention / Treatment: Drug: Dermacyd Femina Pocket BR (Lactic Acid)

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil
    • Sanofi-Aventis Administrative Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Dermacyd Femina Pocket BR (Lactic Acid)	Drug: Dermacyd Femina Pocket BR (Lactic Acid); Dermacyd Femina Pocket BR (Lactic Acid) during 21 consecutive days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Absence of irritation	From the start to the end of the study
Good acceptability	From the start to the end of the study

Collaborators and Investigators

• Sponsor: Sanofi

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): November 1, 2008

Study Registration Dates

• First Submitted: November 17, 2008
• First Submitted That Met QC Criteria: November 19, 2008
• First Posted (Estimate): November 20, 2008

Study Record Updates

• Last Update Posted (Estimate): December 19, 2008
• Last Update Submitted That Met QC Criteria: December 18, 2008
• Last Verified: December 1, 2008

More Information

Terms related to this study

• Other Study ID Numbers: LACAC_L_04369