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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Water; Drug: azelaic acid pre-foam formulation; Drug: Vehicle pre-foam formulation; Drug: Sodium lauryl sulfate

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Robert I. Cooper, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
irritancy rating scale	skin reaction as well as superficial layer effects will be scored according to standardized scales	21 days

Collaborators and Investigators

• Sponsor: LEO Pharma
• Collaborators: Bayer

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: September 6, 2011
• First Submitted That Met QC Criteria: September 7, 2011
• First Posted (Estimate): September 8, 2011

Study Record Updates

• Last Update Posted (Actual): April 1, 2020
• Last Update Submitted That Met QC Criteria: March 30, 2020
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: dermal irritative potential
• Additional Relevant MeSH Terms: Antineoplastic Agents; Dermatologic Agents; Azelaic acid
• Other Study ID Numbers: 15853; 1401841 (Other Identifier: Company internal)