21 Day Irritancy Test of Azelaic Acid Pre-foam Formulation

• Sponsor: LEO Pharma (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01430312
• Collaborator: Bayer (Industry)
• Enrollment: 40
• Location: 1
• Arms: 4
• Duration (Months): 3
• Patients Per Site Per Month: 13.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: azelaic acid pre-foam formulation; Drug: Vehicle pre-foam formulation; Drug: Water; Drug: Sodium lauryl sulfate	Phase 1

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: 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
• Study Start Date: Sep 1, 2011
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Verum Topical application of verum (azelaic acid pre-foam formulation) on the skin	Drug: azelaic acid pre-foam formulation
Placebo Comparator: Vehicle Topical application of vehicle formulation (same as verum but without active drug substance) on the skin	Drug: Vehicle pre-foam formulation
Placebo Comparator: Negative control Topical application of distilled water (negative control) on the skin	Drug: Water
Active Comparator: Positive control Topical application of 0.5% Sodium Lauryl sulfate (positive control) on the skin	Drug: Sodium lauryl sulfate

Outcome Measures

Primary Outcome Measures

1. irritancy rating scale [21 days]

   skin reaction as well as superficial layer effects will be scored according to standardized scales

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• healthy volunteers

• male ore female subjects

• aged 18 - 65 years

• ability to understand and fulfill the study requirements

Exclusion Criteria:

• affected skin in designated test area

• pregnancy or lactation

• not willing to comply with study requirements

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Robert I. Cooper, MD	Fargo	North Dakota	United States	58104

Sponsors and Collaborators

• LEO Pharma
• Bayer

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: LEO Pharma
• ClinicalTrials.gov Identifier: NCT01430312
• Other Study ID Numbers: 15853; 1401841
• First Posted: Sep 8, 2011
• Last Update Posted: Apr 1, 2020
• Last Verified: Feb 1, 2014

• Keywords provided by LEO Pharma: dermal irritative potential
• Additional relevant MeSH terms: Azelaic acid

Study Results

No Results Posted as of Apr 1, 2020