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Completed

NCT Number: NCT01430533

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

The purpose of this study is to determine the dermal sensitization 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

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

azelaic acid pre foam formulation

Drug

Vehicle pre foam formulation

Drug

Water

Drug

Primary outcomes

  1. skin sensitization reaction

    Time frame: 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

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

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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