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Lactacyd Radiance (Lactic Acid) Prophetic Patch Test

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00679562
First received: May 15, 2008
Last updated: February 5, 2009
Last verified: February 2009
History of Changes
  Purpose

Primay objective:

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


Condition Intervention Phase
Hygiene
 Drug: Lactic Acid
Other: Distilled water
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Skin Irritation : Prophetic Patch Test of Lactacyd Radiance

Resource links provided by NLM:

MedlinePlus related topics: Drinking Water
U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Reaction after patch removal. [ Time Frame: at 15-30 minutes and day 3 ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: March 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00679562

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

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00679562     History of Changes
Other Study ID Numbers: LACAC_L_03648
Study First Received: May 15, 2008
Last Updated: February 5, 2009
Health Authority: Thailand: Food and Drug Administration

ClinicalTrials.gov processed this record on May 21, 2013