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Lactacyd Radiance (Lactic Acid) Prophetic Patch Test

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00679562
Recruitment Status : Completed
First Posted : May 19, 2008
Last Update Posted : February 6, 2009
Sponsor:
Information provided by:
Sanofi

Brief Summary:

Primay objective:

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


Condition or disease Intervention/treatment Phase
Hygiene Drug: Lactic Acid Other: Distilled water Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Skin Irritation : Prophetic Patch Test of Lactacyd Radiance
Study Start Date : March 2008
Primary Completion Date : April 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: Lactacyd Radiance
Placebo Comparator: 2 Other: Distilled water
Application of patches containing distilled water for 24 hours



Primary Outcome Measures :
  1. Reaction after patch removal. [ Time Frame: at 15-30 minutes and day 3 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00679562


Locations
Thailand
Sanofi-Aventis Administrative Office
Bangkok, Thailand
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Taweeporn NATESUMROENG Sanofi

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00679562     History of Changes
Other Study ID Numbers: LACAC_L_03648
First Posted: May 19, 2008    Key Record Dates
Last Update Posted: February 6, 2009
Last Verified: February 2009