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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00855595
First received: March 3, 2009
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Papulopustular Rosacea
Drug: Azelaic acid (Finacea, BAY39-6251)
Drug: Metronidazole (Metrogel)
Drug: Doxycycline (Oracea)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions)


Secondary Outcome Measures:
  • Number of Inflammatory Lesions at Weeks 2, 4, 6, 8 and 12 (LOCF) [ Time Frame: Week 2, 4, 6, 8 and 12 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions)

  • 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 ] [ Designated as safety issue: No ]
    NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions)

  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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).

  • 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 ] [ Designated as safety issue: No ]
    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)

  • Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 2 [ Time Frame: At Week 2 ] [ Designated as safety issue: No ]
    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).

  • Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 4 [ Time Frame: At Week 4 ] [ Designated as safety issue: No ]
    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).

  • Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 6 [ Time Frame: At Week 6 ] [ Designated as safety issue: No ]
    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).

  • Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 8 [ Time Frame: At Week 8 ] [ Designated as safety issue: No ]
    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).

  • Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 12 [ Time Frame: At Week 12 ] [ Designated as safety issue: No ]
    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).

  • Investigator Rating of Overall Improvement at End of Study (Week 12) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Patient Rating of Overall Improvement at End of Study (Week 12) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Patient Opinion of Cosmetic Acceptability at End of Study (Week 12) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Patient Opinion of Local Tolerability [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]

Enrollment: 207
Study Start Date: February 2009
Study Completion Date: July 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Azelaic acid (Finacea, BAY39-6251) plus Doxycycline (Oracea)
Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
Drug: Azelaic acid (Finacea, BAY39-6251)
Participants received topical azelaic acid gel 15% twice daily for 12 weeks
Drug: Doxycycline (Oracea)
Participants received systemic doxycycline 40 mg once daily for 12 week
Active Comparator: Metronidazole (Metrogel) plus Doxycycline (Oracea)
Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
Drug: Metronidazole (Metrogel)
Participants received topical metronidazole 1% gel once daily for 12 weeks
Drug: Doxycycline (Oracea)
Participants received systemic doxycycline 40 mg once daily for 12 week

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00855595

Locations
United States, Alabama
Birmingham, Alabama, United States, 35233
United States, Colorado
Denver, Colorado, United States, 80209
United States, Florida
West Palm Beach, Florida, United States, 33401
United States, Massachusetts
Boston, Massachusetts, United States, 02114-2517
United States, Michigan
Warren, Michigan, United States, 48088
United States, Minnesota
Fridley, Minnesota, United States, 55432
United States, Nevada
Henderson, Nevada, United States, 89052
United States, New Mexico
Albuquerque, New Mexico, United States, 87106
United States, New York
Stony Brook, New York, United States, 11790
United States, Ohio
Mason, Ohio, United States, 45040
United States, Oregon
Portland, Oregon, United States, 97223
United States, Texas
Austin, Texas, United States, 78759
Dallas, Texas, United States, 75246
Houston, Texas, United States, 77056
San Antonio, Texas, United States, 78229
United States, Utah
Salt Lake City, Utah, United States, 84124
United States, Virginia
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Publications:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00855595     History of Changes
Other Study ID Numbers: 14366, 1402604, 256-0024
Study First Received: March 3, 2009
Results First Received: July 25, 2012
Last Updated: January 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Bayer:
Rosacea

Additional relevant MeSH terms:
Rosacea
Skin Diseases
Metronidazole
Doxycycline
Anti-Inflammatory Agents
Azelaic acid
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents
Antiparasitic Agents
Radiation-Sensitizing Agents
Anti-Bacterial Agents
Antimalarials
Antineoplastic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on October 19, 2014