NCT01430312

21 Day Irritancy Test of Azelaic Acid Pre-foam Formulation

A Randomized, Double-blind, Vehicle-controlled Phase 1 Dermal Safety Study Using a 21 Day Cumulative Irritant Patch Test Design to Evaluate the Local Tolerability of Azelaic Acid Pre-Foam Formulation in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: LEO Pharma · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the irritancy potential of azelaic acid pre-foam formulation.

Detailed description

This is the standard patch test over 21 days of exposure of the test product,its vehicle and a positive as well as a negative control.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	azelaic acid pre-foam formulation
DRUG	Vehicle pre-foam formulation
DRUG	Water
DRUG	Sodium lauryl sulfate

Timeline

• Start date: 2011-09-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2011-09-08
• Last updated: 2020-04-01

Locations

1 site across 1 country: United States