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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014