NCT01430533

Human Repeated Insult Patch Test (HRIPT) of Azelaic Acid Pre Foam Formulation

A Randomized, Double-blind, Vehicle Controlled Phase 1 Dermal Safety Study to Evaluate the Sensitizing Potential of Topically Applied Azelaic Acid Pre-foam Formulation in Healthy Subjects Using a Human Repeated Insult Patch Test Design

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 240 (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 dermal sensitization potential of azelaic acid pre-foam formulation.

Detailed description

In an induction phase a three times weekly exposure over three weeks will be performed, followed by a resting phase. In a following challenge phase single exposure will be performed again and potential skin reactions observed. If skin reactions occur an optional re-challenge phase may be performed.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	azelaic acid pre foam formulation
DRUG	Vehicle pre foam formulation
DRUG	Water

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