check_circleStudy Completed

Papulopustular rosacea

Bayer Identifier:

14366

ClinicalTrials.gov Identifier:

NCT00855595

EudraCT Number:

Not Available

EU CT Number:

Not Available
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

Trial 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.

Key Participants Requirements

Sex

Both

Age

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

Trial summary

Enrollment Goal
207
Trial Dates
February 2009 - July 2009
Phase
Phase 4
Could I Receive a placebo
No
Products
Finacea (Azelaic Acid, BAY39-6251)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Kenneth R. Beer, MD, PAWest Palm Beach, 33401, United States
Completed
The Center for Skin ResearchHouston, 77056, United States
Completed
James Del Rosso, DOHenderson, 89052, United States
Completed
Univeristy of Alabama at BirminghamBirmingham, 35233, United States
Completed
The Grekin Skin InstituteWarren, 48088, United States
Completed
DermResearch, Inc.Austin, 78759, United States
Completed
Minnesota Clinical Study CenterFridley, 55432, United States
Completed
(CURTIS) Mass General Women’s Hospitals Harvard Medical SchoolBoston, 02114-2517, United States
Completed
Progressive Clinical ResearchSan Antonio, 78229, United States
Completed
Cherry Creek Research, Inc.Denver, 80209, United States
Completed
Oregon Medical Research Center, PCPortland, 97223, United States
Completed
Baylor Research InstituteDallas, 75246, United States
Completed
David M. Pariser, MDNorfolk, 23507, United States
Completed
DermResearch Center of New YorkStony Brook, 11790, United States
Completed
Dermatology Research Center, IncSalt Lake City, 84124, United States
Completed
Jan Fu, MDMason, 45040, United States
Completed
Eduardo Tschen, MDAlbuquerque, 87106, United States

Primary Outcome

  • Nominal change from Baseline in inflammatory lesion (IL) count (sum of papules and pustules) at Week 2 (LOCF: last observation carried forward)
    date_rangeTime Frame:
    Baseline and Week 2
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Number of inflammatory lesions at Weeks 2, 4, 6, 8 and 12 (LOCF)
    date_rangeTime Frame:
    Week 2, 4, 6, 8 and 12
    enhanced_encryption
    Safety Issue:
    No
  • Nominal change from Baseline in IL count at Weeks 4, 6, 8 and 12 (LOCF)
    date_rangeTime Frame:
    Baseline and Week 4, 6, 8 and 12
    enhanced_encryption
    Safety Issue:
    No
  • Percent change from Baseline in IL count at Weeks 2, 4, 6, 8 and 12 (LOCF)
    date_rangeTime Frame:
    Baseline and Week 2, 4, 6, 8 and 12
    enhanced_encryption
    Safety Issue:
    No
  • 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)
    date_rangeTime Frame:
    Baseline and Weeks 2, 4, 6, 8 and 12
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with Investigator’s Global Assessment (IGA) based therapeutic success at Weeks 2, 4, 6, 8 and 12 (LOCF)
    date_rangeTime Frame:
    Weeks 2, 4, 6, 8 and 12
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with IGA based patient response at Weeks 2, 4, 6, 8 and 12 (LOCF)
    date_rangeTime Frame:
    Weeks 2, 4, 6, 8 and 12
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with respective disease severity measured by IGA scores at Week 2
    date_rangeTime Frame:
    At Week 2
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with respective disease severity measured by IGA scores at Week 4
    date_rangeTime Frame:
    At Week 4
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with respective disease severity measured by IGA scores at Week 6
    date_rangeTime Frame:
    At Week 6
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with respective disease severity measured by IGA scores at Week 8
    date_rangeTime Frame:
    At Week 8
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with respective disease severity measured by IGA scores at Week 12
    date_rangeTime Frame:
    At Week 12
    enhanced_encryption
    Safety Issue:
    No
  • Investigator rating of overall improvement at end of study (Week 12)
    date_rangeTime Frame:
    Week 12
    enhanced_encryption
    Safety Issue:
    No
  • Patient rating of overall improvement at end of study (Week 12)
    date_rangeTime Frame:
    Week 12
    enhanced_encryption
    Safety Issue:
    No
  • Patient opinion of cosmetic acceptability at end of study (Week 12)
    date_rangeTime Frame:
    Week 12
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Single Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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