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Completed

NCT Number: NCT00855595

Efficacy of Topical Azelaic Acid 15% Gel Plus Anti-inflammatory Dose Doxycycline or Metronidazole Gel 1% Plus Anti-inflammatory Dose Doxycycline in Moderate Papulopustular Rosacea

Subjects with moderate papulopustular rosacea will be treated either with azelaic acid 15% gel topically plus an anti-inflammatory dose of doxycyline (40mg) daily or with metronidazole 1% gel topically once daily plus an anti-inflammatory dose of doxycycline (40mg) over at total of twelve weeks to determine the rapidity of improvement, and the length of time to reach 25%, 50% and 75% clearing compared to baseline.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Birmingham, Alabama, United States

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About this study

The change in inflammatory lesion count will be assessed at each post-baseline visit by an analysis of variance model (ANOVA) with factors treatment and center, but not including treatment-by-center interaction.

Investigator's Global Assessment (IGA) of papulopustular rosacea (static score): 0 - Clear (Virtually no rosacea ie, no papules and/or pustules; no or residual erythema; no or mild to moderate degree of telangiectasia may be present); 1 - Minimal (Rare papules and/or pustules; residual to mild erythema; mild to moderate degree of telangiectasia may be present); 2 - Mild (Few papules and/or pustules; mild erythema; mild to moderate degree of telangiectasia may be present); 3 - Mild to moderate (Distinct number of papules and/or pustules; mild to moderate erythema; mild to moderate degree of telangiectasia may be present); 4 - Moderate (Pronounced number of papules and/or pustules; moderate erythema; mild to moderate degree of telangiectasia may be present); 5 - Moderate to severe (Many papules and/or pustules, occasionally with large inflamed lesions; moderate erythema; moderate degree of telangiectasia may be present); 6 - Severe (Numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate or severe erythema; moderate or severe degree of telangiectasia may be present).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Moderate papulopustular rosacea (IGA>4) with a minimum of 10 and no more than 50 inflammatory lesions and persistent erythema with or without telangiectasia

Exclusion criteria

  • Sensitivity to any of the treatments used
  • Co-existing conditions that would unfavorably influence the course of the disease
  • Pregnant or lactating women
  • Severe rosacea

Treatment and study plan

Azelaic acid (Finacea, BAY39-6251)

Drug

Participants received topical azelaic acid gel 15% twice daily for 12 weeks

Metronidazole (Metrogel)

Drug

Participants received topical metronidazole 1% gel once daily for 12 weeks

Doxycycline (Oracea)

Drug

Participants received systemic doxycycline 40 mg once daily for 12 week

Primary outcomes

  1. Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) at Week 2 (LOCF: Last Observation Carried Forward)

    Time frame: Baseline and Week 2

    NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions)

Secondary outcomes

  1. Number of Inflammatory Lesions at Weeks 2, 4, 6, 8 and 12 (LOCF)

    Time frame: Week 2, 4, 6, 8 and 12

  2. Nominal Change From Baseline in IL Count at Weeks 4, 6, 8 and 12 (LOCF)

    Time frame: Baseline and Week 4, 6, 8 and 12

    NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions)

  3. Percent Change From Baseline in IL Count at Weeks 2, 4, 6, 8 and 12 (LOCF)

    Time frame: Baseline and Week 2, 4, 6, 8 and 12

    NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions)

  4. Percentage of Participants With at Least a 25%, 50%, or 75% Improvement in Facial IL Counts From Baseline to Weeks 2, 4, 6, 8 and 12 (LOCF)

    Time frame: Baseline and Weeks 2, 4, 6, 8 and 12

  5. Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at Weeks 2, 4, 6, 8 and 12 (LOCF)

    Time frame: Weeks 2, 4, 6, 8 and 12

    IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information) / Therapeutic success is defined as an IGA score of clear or minimal (0 or 1).

  6. Percentage of Participants With IGA Based Patient Response at Weeks 2, 4, 6, 8 and 12 (LOCF)

    Time frame: Weeks 2, 4, 6, 8 and 12

    IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information) / Patient response is defined as an IGA score of clear, minimal, or mild (0, 1, or 2)

  7. Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 2

    Time frame: At Week 2

    IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).

  8. Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 4

    Time frame: At Week 4

    IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).

  9. Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 6

    Time frame: At Week 6

    IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).

  10. Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 8

    Time frame: At Week 8

    IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).

  11. Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 12

    Time frame: At Week 12

    IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).

  12. Investigator Rating of Overall Improvement at End of Study (Week 12)

    Time frame: Week 12

  13. Patient Rating of Overall Improvement at End of Study (Week 12)

    Time frame: Week 12

  14. Patient Opinion of Cosmetic Acceptability at End of Study (Week 12)

    Time frame: Week 12

Other outcomes

  1. Patient Opinion of Local Tolerability

    Time frame: Week 12

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Collaborators

  • Bayer

Registry information

Official study title

An Exploratory, Multicenter, Investigator-blinded, Active-controlled Study to Investigate the Efficacy of Topical Azelaic Acid (AzA)15% Gel Twice Daily or Metronidazole Topical Gel 1% Once Daily, Plus Anti-inflammatory Dose Doxycycline (40mg) Once Daily in Subjects With Moderate Papulopustular Rosacea

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Mar 4, 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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