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

Sponsor

LEO Pharma (Industry)

Overall Status

Completed

CT.gov ID

NCT01430533

Collaborator

Bayer (Industry)

240

Enrollment

Location

Arms

Duration (Months)

80.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the dermal sensitization 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	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

240 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 to Evaluate the Sensitizing Potential of Topically Applied Azelaic Acid Pre-foam Formulation in Healthy Subjects Using a Human Repeated Insult Patch Test Design

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

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

Outcome Measures

Primary Outcome Measures

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

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 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

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:

NCT01430533

Other Study ID Numbers:

15854
1401842

First Posted:

Sep 8, 2011

Last Update Posted:

Apr 1, 2020

Last Verified:

Feb 1, 2014

Keywords provided by LEO Pharma

dermal sensitization potential

Additional relevant MeSH terms:

Azelaic acid

Study Results

No Results Posted as of Apr 1, 2020