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

The purpose of this study is to determine the dermal sensitization 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

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.

• Study Type: Interventional
• Enrollment (Actual): 240
• 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 or 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

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
Experimental: Verum; Topical application of verum (azelaic acid pre foam formulation) on the skin	Drug: azelaic acid pre foam formulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
skin sensitization reaction	skin reactions will be assessed, using a standardized scoring scale	day 3 to 6 of challenge phase week (week 6 or later, at least 2 weeks after the 3 week induction phase)

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 sensitization potential
• Additional Relevant MeSH Terms: Antineoplastic Agents; Dermatologic Agents; Azelaic acid
• Other Study ID Numbers: 15854; 1401842 (Other Identifier: Company Internal)