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21 Day Irritancy Test of Azelaic Acid Pre-foam Formulation

Information source: Bayer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: azelaic acid pre-foam formulation (Drug); Vehicle pre-foam formulation (Drug); Water (Drug); Sodium lauryl sulfate (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer


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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Primary outcome: irritancy rating scale

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.


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


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

Locations and Contacts

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

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Starting date: September 2011
Last updated: February 27, 2014

Page last updated: August 20, 2015

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