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Completed

NCT Number: NCT01025635

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

This study will investigate the safety and efficacy of a new formulation of an existing medication for the treatment of papulopustular rosacea. The study will test the active ingredient plus foam against foam alone.

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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 2

Primary location

Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Signed written informed consent
  • Diagnosis of papulopustular rosacea (IGA score of moderate or severe) with a minimum of 12 and maximum of 50 inflammatory lesions (papules and/or pustules) and persistent erythema with or without telangiectasia
  • Free of any clinically significant disease which could interfere with the study
  • Willingness to follow all study procedures
  • Male or female patient at least 18 years of age

Exclusion criteria

  • Subjects known to be non-responders to azelaic acid
  • Presence of dermatoses that might interfere with the rosacea diagnosis or the evaluation of treatment results
  • Ocular rosacea, phymatous rosacea
  • Any condition or therapy that in the opinion of the investigator may pose a risk to the patient of interfere with any evaluation in the study
  • Facial laser surgery in the 6 weeks prior to the study
  • Topical or systemic use of prescription or non-prescription medications to treat rosacea
  • Use of any agent other than the investigational drugs to treat rosacea during the study
  • Expected use or change in dose in the 90 days prior to the study of beta-blockers, vasodilators, NSAIDs, hormonal treatment or drugs causing acneiform eruptions
  • Known hypersensitivity to any ingredients of the investigational product formulation
  • Alcohol or drug abuse
  • Incapability of giving fully informed consent
  • Subject is dependent person, i.e., a relative/family member of the investigator and/or is a member of the investigator's staff
  • Participation in another clinical research study within the last 4 weeks before randomization in this study

Treatment and study plan

Azelaic Acid foam 15%

Drug

Applied topically twice daily for 12 weeks

Vehicle Foam

Drug

Applied topically twice daily for 12 weeks

Primary outcomes

  1. Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Treatment (LOCF: Last Observation Carried Forward)

    Time frame: At End of treatment (up to 12 weeks) (LOCF)

    The IGA is a static evaluation of the overall severity of papulopustular rosacea at a given time. It consists of 5 scores ranging from clear to severe papulopustular rosacea and allows rapid overall evaluation of disease severity: 1) Clear: virtually no rosacea, ie, no papules and/or pustules; no erythema; 2) Minimal: rare papules and/or pustules; residual to mild erythema; 3) Mild: few papules and/or pustules; mild erythema; 4) Moderate: pronounced number of papules and/or pustules; moderate erythema; 5) Severe: numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate to severe erythema. Therapeutic success is defined as an IGA score of clear or minimal.

  2. Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) Per Participant at End of Treatment (LOCF)

    Time frame: Baseline and End of treatment (up to 12 weeks) (LOCF)

Secondary outcomes

  1. Percent Change From Baseline in IL Count (Sum of Papules and Pustules) Per Participant at End of Treatment (LOCF)

    Time frame: At End of treatment (up to 12 weeks) (LOCF)

  2. Percentage of Participants With Investigator's Global Assessment (IGA) Based Patient Response at End of Treatment (LOCF)

    Time frame: At End of treatment (up to 12 weeks) (LOCF)

    The IGA is a static evaluation of the overall severity of papulopustular rosacea at a given time. It consists of 5 scores ranging from clear to severe papulopustular rosacea and allows rapid overall evaluation of disease severity: 1) Clear: virtually no rosacea, ie, no papules and/or pustules; no erythema; 2) Minimal: rare papules and/or pustules; residual to mild erythema; 3) Mild: few papules and/or pustules; mild erythema; 4) Moderate: pronounced number of papules and/or pustules; moderate erythema; 5) Severe: numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate to severe erythema. Subjects achieving a clear, minimal, or mild IGA at the end of treatment were considered as 'responder'. Subjects with an IGA of moderate or severe at the end of treatment were considered as 'non-responder'. Subjects who prematurely withdraw from study treatment because of lack of efficacy were coded as 'non-responders'.

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Collaborators

  • Bayer

Registry information

Official study title

Randomized, Double-blind, Vehicle-controlled, Multicenter, Parallel-group Study to Investigate Safety and Efficacy of Azelaic Acid Foam, 15% Topically Applied Twice Daily in Subjects With Papulopustular Rosacea

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 3, 2009
Registry last updated
Mar 31, 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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