Lactacyd Radiance (Lactic Acid) Prophetic Patch Test

February 5, 2009 updated by: Sanofi

Skin Irritation : Prophetic Patch Test of Lactacyd Radiance

Primay objective:

To evaluate the potential of the products in eliciting adverse skin reaction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 2

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

  • Thailand
      • Bangkok, Thailand
        • 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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Test area should have a healthy or normal skin
  • Individuals free of any systemic or dermatological disorder which, in the opinion of the investigative personnel would interfere with the study results or increase the risk of adverse reaction
  • Not currently use of steroid or any medication during the test

Exclusion Criteria:

  • History of Allergy or Allergic Reaction to:

    • Hey Fever
    • Asthma
    • Poison Ivy
    • Food
    • Cosmetics
    • Soap
    • Detergent
    • Metal
    • Jewelry
    • Lather
    • Fabric
    • Medication

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: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Lactic Acid
Application of occlusive patches containing test product. For 24 hours and repeat 2 weeks later for participants with no reaction to Lactacyd Radiance
Other Names:
  • Lactacyd Radiance
Placebo Comparator: 2
Other: Distilled water
Application of patches containing distilled water for 24 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reaction after patch removal.
Time Frame: at 15-30 minutes and day 3
at 15-30 minutes and day 3

Collaborators and Investigators

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

Sponsor

Sanofi

Investigators

  • Study Director: Taweeporn NATESUMROENG, Sanofi

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

March 1, 2008

Primary Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

May 15, 2008

First Submitted That Met QC Criteria

May 15, 2008

First Posted (Estimate)

May 19, 2008

Study Record Updates

Last Update Posted (Estimate)

February 6, 2009

Last Update Submitted That Met QC Criteria

February 5, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Other Study ID Numbers

  • LACAC_L_03648

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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