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Completed

NCT Number: NCT00417937

A Multicenter Trial of a Topical Medication for Papulopustular Rosacea Applied Twice Daily Versus Once Daily

To assess the efficacy and tolerability of azelaic acid 15% gel applied once daily versus twice daily in the treatment of patients with papulopustular rosacea.

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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 4

Primary location

Intendis GmbH

Berlin, Germany

About this study

To test the efficacy and safety of once vs twice daily application of azelaic acid 15% gel on papulopustular rosacea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Papulopustular facial rosacea; minimum of 10, maximum of 50 inflamed papules and/or pustules

Exclusion criteria

  • Mild or severe rosacea
  • Rosacea with marked ocular manifestations
  • Presence of dermatoses that could interfere with the rosacea diagnosis or evaluation of the study course
  • Wash out period required for patients treated prior to study with topical retinoids, oral antibiotics, topical antibiotics, systemic and topical corticosteroids, topical imidazole, laser surgery for telangiectasia
  • History of hypersensitivity to propylene glycol

Treatment and study plan

Azelaic acid 15% Gel

Drug

15% gel, topically applied once daily for six weeks

Primary outcomes

  1. Investigator's global assessment scored on a seven point scale

    Time frame: Measurements made during the course of treatment

Secondary outcomes

  1. Inflammatory lesion count, erythema, telangiectasia, patient self assessment, patient opinion about therapy

    Time frame: Parameters measured during the course of treatment

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Collaborators

  • Bayer

Registry information

Official study title

A Multicenter, Double-Blind Clinical Trial to Assess the Efficacy and Tolerability of Topical Azelaic Acid 15% Gel Once Daily Compared to Topical Azelaic Acid 15% gelTwice Daily in Subjects With Papulopustular Rosacea

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Jan 4, 2007
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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