Lactacyd Radiance (Lactic Acid) Prophetic Patch Test - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00679562

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 II

MedlinePlus related topics: Drinking Water

Drug Information available for: Lactic acid Ammonium lactate

Study Type:	Interventional
Study Design:	Supportive Care, Non-Randomized, Open Label, Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Skin Irritation : Prophetic Patch Test of Lactacyd Radiance

Further study details as provided by Sanofi-Aventis:

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
1: Experimental	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
2: Placebo Comparator	Other: Distilled water Application of patches containing distilled water for 24 hours

Eligibility

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:

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-Aventis

Investigators

Study Director:

Taweeporn NATESUMROENG

Sanofi-Aventis

More Information

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	LACAC_L_03648
Study First Received:	May 15, 2008
Last Updated:	July 3, 2008
ClinicalTrials.gov Identifier:	NCT00679562
Health Authority:	Thailand: Food and Drug Administration

ClinicalTrials.gov processed this record on January 15, 2009