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OpenTrials
Completed

NCT Number: NCT01257919

Safety and Pharmacokinetics of Azelaic Acid Foam, 15% in Papulopustular Rosacea

Assessment of pharmacokinetics of Azelaic Acid Foam after repeated skin application and in comparison to Azelaic Acid gel.

Assessment of safety after repeated skin application.

Completed

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Key information

Conditions

Papulopustular Rosacea Rosacea Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novum Pharmaceutical Research Services of Nevada Inc.

Las Vegas, Nevada, 89121, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • diagnosis of moderate papulopustular rosacea
  • free of any clinically significant disease

Exclusion criteria

  • body weight less than 50 or more than 130 kg
  • clinically significant disease which could interfere with the study

Treatment and study plan

Azelaic Acid Foam

Drug

Dermal application of Azelaic Acid Foam

Azelaic Acid Gel

Drug

Dermal application of Azelaic Acid Gel

Primary outcomes

  1. Baseline corrected area under the curve (AUC)

    Time frame: 12 hours

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Collaborators

  • Bayer

Registry information

Official study title

Investigator-blinded, Randomized, Cross-over, Multiple Dose Phase I Study on Safety and Pharmacokinetics of Topically Applied Azelaic Acid Foam, 15% Compared to Azelaic Acid Gel, 15% in Subjects With Papulopustular Rosacea

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Dec 10, 2010
Registry last updated
Jun 9, 2023

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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