Dermacyd PH_DETINLYN Sweet Flower (Lactic Acid) - Safety

March 5, 2009 updated by: Sanofi

Safety Dermatological Evaluation: Genital Mucous Irritation - Product Tested: Dermacyd PH_DETINLYN Sweet Flower (Lactic Acid).

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Integral skin test in the region,
  • Use of cosmetic product of the same category

Exclusion Criteria:

  • Lactation or gestational risk or gestation
  • Use of Anti-inflammatory, immunosuppression or anti-histaminic drugs
  • Atopic antecedent or allergic to cosmetic product
  • Active cutaneous disease in the evaluation area
  • Diseases which cause immunology decrease, such as diabetes and HIV
  • Endocrinal pathologies
  • Intense solar exposure 15 days before the evaluation
  • Treatment until four months before the selection

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Dermacyd PH_DETINLYN Sweet Flower (Lactic Acid)
Drug: Dermacyd PH_DETINLYN Sweet Flower (Lactic Acid)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The absence of irritation and the good acceptability will be evaluated using one specific scale which describes the intensity of the reaction.
Time Frame: From treatment start to the end of study
From treatment start to the end of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

November 4, 2008

First Submitted That Met QC Criteria

November 4, 2008

First Posted (Estimate)

November 5, 2008

Study Record Updates

Last Update Posted (Estimate)

March 6, 2009

Last Update Submitted That Met QC Criteria

March 5, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Other Study ID Numbers

  • LACAC_L_04298

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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