Lactacyd Radiance (Lactic Acid) Prophetic Patch Test

Hygiene Clinical Trial

Official title:

Skin Irritation : Prophetic Patch Test of Lactacyd Radiance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00679562
• Other study ID #: LACAC_L_03648
• Status: Completed
• Phase: Phase 2
• First received: May 15, 2008
• Last updated: February 5, 2009
• Start date: March 2008

Study information

• Verified date: February 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Primay objective:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. primary completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hygiene

Intervention

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:
• Distilled water
Application of patches containing distilled water for 24 hours

Locations

Country	Name	City	State
Thailand	Sanofi-Aventis Administrative Office	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reaction after patch removal.		at 15-30 minutes and day 3	No