Lactacyd Radiance (Lactic Acid) Prophetic Patch Test

Phase 2

Completed

• Conditions: Hygiene
• Interventions: Other: Distilled water; Drug: Lactic Acid

• Registration Number: NCT00679562
• Lead Sponsor: Sanofi

Brief Summary

Primay objective:

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2008-04
• Study First Submitted: 2008-05-15
• Study First Submitted QC: 2008-05-15
• Study First Posted: 2008-05-19
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-05
• Last Update Posted: 2009-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	Distilled water	-
1	Lactic Acid	-

Primary Outcome Measures

Name	Time	Method
Reaction after patch removal.	at 15-30 minutes and day 3

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇹🇭 Bangkok, Thailand