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
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
3 other identifiers
interventional
207
1 country
17
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2009
Shorter than P25 for phase_4
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 3, 2009
CompletedFirst Posted
Study publicly available on registry
March 4, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedResults Posted
Study results publicly available
August 29, 2012
CompletedMarch 31, 2020
January 1, 2014
2 months
March 3, 2009
July 25, 2012
March 30, 2020
Conditions
Keywords
Outcome Measures
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)
NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions)
Baseline and Week 2
Secondary Outcomes (14)
Number of Inflammatory Lesions at Weeks 2, 4, 6, 8 and 12 (LOCF)
Week 2, 4, 6, 8 and 12
Nominal Change From Baseline in IL Count at Weeks 4, 6, 8 and 12 (LOCF)
Baseline and Week 4, 6, 8 and 12
Percent Change From Baseline in IL Count at Weeks 2, 4, 6, 8 and 12 (LOCF)
Baseline and Week 2, 4, 6, 8 and 12
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)
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)
Weeks 2, 4, 6, 8 and 12
- +9 more secondary outcomes
Other Outcomes (1)
Patient Opinion of Local Tolerability
Week 12
Study Arms (2)
Azelaic acid (Finacea, BAY39-6251) plus Doxycycline (Oracea)
EXPERIMENTALParticipants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
Metronidazole (Metrogel) plus Doxycycline (Oracea)
ACTIVE COMPARATORParticipants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
Interventions
Participants received topical azelaic acid gel 15% twice daily for 12 weeks
Participants received topical metronidazole 1% gel once daily for 12 weeks
Participants received systemic doxycycline 40 mg once daily for 12 week
Eligibility Criteria
You may qualify if:
- \- Moderate papulopustular rosacea (IGA\>4) with a minimum of 10 and no more than 50 inflammatory lesions and persistent erythema with or without telangiectasia
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LEO Pharmalead
- Bayercollaborator
Study Sites (17)
Unknown Facility
Birmingham, Alabama, 35233, United States
Unknown Facility
Denver, Colorado, 80209, United States
Unknown Facility
West Palm Beach, Florida, 33401, United States
Unknown Facility
Boston, Massachusetts, 02114-2517, United States
Unknown Facility
Warren, Michigan, 48088, United States
Unknown Facility
Fridley, Minnesota, 55432, United States
Unknown Facility
Henderson, Nevada, 89052, United States
Unknown Facility
Albuquerque, New Mexico, 87106, United States
Unknown Facility
Stony Brook, New York, 11790, United States
Unknown Facility
Mason, Ohio, 45040, United States
Unknown Facility
Portland, Oregon, 97223, United States
Unknown Facility
Austin, Texas, 78759, United States
Unknown Facility
Dallas, Texas, 75246, United States
Unknown Facility
Houston, Texas, 77056, United States
Unknown Facility
San Antonio, Texas, 78229, United States
Unknown Facility
Salt Lake City, Utah, 84124, United States
Unknown Facility
Norfolk, Virginia, 23507, United States
Related Publications (1)
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.
PMID: 20645521RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- Intendis GmbH
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2009
First Posted
March 4, 2009
Study Start
February 1, 2009
Primary Completion
April 1, 2009
Study Completion
July 1, 2009
Last Updated
March 31, 2020
Results First Posted
August 29, 2012
Record last verified: 2014-01