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
NCT ID: NCT00855595
Last Updated: 2020-03-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
207 participants
INTERVENTIONAL
2009-02-28
2009-07-31
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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
Azelaic acid (Finacea, BAY39-6251)
Participants received topical azelaic acid gel 15% twice daily for 12 weeks
Doxycycline (Oracea)
Participants received systemic doxycycline 40 mg once daily for 12 week
Metronidazole (Metrogel) plus Doxycycline (Oracea)
Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
Metronidazole (Metrogel)
Participants received topical metronidazole 1% gel once daily for 12 weeks
Doxycycline (Oracea)
Participants received systemic doxycycline 40 mg once daily for 12 week
Interventions
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Azelaic acid (Finacea, BAY39-6251)
Participants received topical azelaic acid gel 15% twice daily for 12 weeks
Metronidazole (Metrogel)
Participants received topical metronidazole 1% gel once daily for 12 weeks
Doxycycline (Oracea)
Participants received systemic doxycycline 40 mg once daily for 12 week
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Co-existing conditions that would unfavorably influence the course of the disease
* Pregnant or lactating women
* Severe rosacea
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
LEO Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Birmingham, Alabama, United States
Denver, Colorado, United States
West Palm Beach, Florida, United States
Boston, Massachusetts, United States
Warren, Michigan, United States
Fridley, Minnesota, United States
Henderson, Nevada, United States
Albuquerque, New Mexico, United States
Stony Brook, New York, United States
Mason, Ohio, United States
Portland, Oregon, United States
Austin, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Norfolk, Virginia, United States
Countries
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References
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Del Rosso JQ, Bruce S, Jarratt M, Menter A, Staedtler G. Efficacy of topical azelaic acid (AzA) gel 15% plus oral doxycycline 40 mg versus metronidazole gel 1% plus oral doxycycline 40 mg in mild-to-moderate papulopustular rosacea. J Drugs Dermatol. 2010 Jun;9(6):607-13.
Other Identifiers
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1402604
Identifier Type: OTHER
Identifier Source: secondary_id
256-0024
Identifier Type: OTHER
Identifier Source: secondary_id
14366
Identifier Type: -
Identifier Source: org_study_id
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