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Completed

NCT Number: NCT01430312

21 Day Irritancy Test of Azelaic Acid Pre-foam Formulation

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

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Robert I. Cooper, MD

Fargo, North Dakota, 58104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

azelaic acid pre-foam formulation

Drug

Vehicle pre-foam formulation

Drug

Water

Drug

sodium lauryl sulfate

Drug

Primary outcomes

  1. irritancy rating scale

    Time frame: 21 days

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

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Collaborators

  • Bayer

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Sep 8, 2011
Registry last updated
Apr 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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