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
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ClinicalTrials.gov Identifier: NCT00855595 |
Recruitment Status :
Completed
First Posted : March 4, 2009
Results First Posted : August 29, 2012
Last Update Posted : March 31, 2020
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Condition or disease | Intervention/treatment | Phase |
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Papulopustular Rosacea | Drug: Azelaic acid (Finacea, BAY39-6251) Drug: Metronidazole (Metrogel) Drug: Doxycycline (Oracea) | Phase 4 |
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).
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 207 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (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 |
Study Start Date : | February 2009 |
Actual Primary Completion Date : | April 2009 |
Actual Study Completion Date : | July 2009 |

Arm | Intervention/treatment |
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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
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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
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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 |
- 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)
- Number of Inflammatory Lesions at Weeks 2, 4, 6, 8 and 12 (LOCF) [ Time Frame: Week 2, 4, 6, 8 and 12 ]
- 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)
- 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)
- 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 ]
- 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).
- 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)
- 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).
- 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).
- 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).
- 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).
- 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).
- Investigator Rating of Overall Improvement at End of Study (Week 12) [ Time Frame: Week 12 ]
- Patient Rating of Overall Improvement at End of Study (Week 12) [ Time Frame: Week 12 ]
- Patient Opinion of Cosmetic Acceptability at End of Study (Week 12) [ Time Frame: Week 12 ]
- Patient Opinion of Local Tolerability [ Time Frame: Week 12 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00855595
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 |
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | LEO Pharma |
ClinicalTrials.gov Identifier: | NCT00855595 |
Other Study ID Numbers: |
14366 1402604 ( Other Identifier: Intendis GmbH ) 256-0024 ( Other Identifier: Intendis GmbH ) |
First Posted: | March 4, 2009 Key Record Dates |
Results First Posted: | August 29, 2012 |
Last Update Posted: | March 31, 2020 |
Last Verified: | January 2014 |
Rosacea |
Rosacea Skin Diseases Metronidazole Doxycycline Azelaic acid Anti-Infective Agents |
Anti-Bacterial Agents Antiprotozoal Agents Antiparasitic Agents Antimalarials Antineoplastic Agents Dermatologic Agents |