check_circleStudy Completed

Papulopustular Rosacea

Bayer Identifier:

1402140

ClinicalTrials.gov Identifier:

NCT00617903

EudraCT Number:

Not Available

EU CT Number:

Not Available
Exploration of safety and efficacy of AzA 15% foam twice a day in rosacea

Trial purpose

This exploratory study is being performed to determine whether a new form formulation of azelaic acid 15% is effective in the treatment of papulopustular rosecea.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - male and female patient at least 18 years of age
    - signed informed consent
    - Papulopustular rosacea with a minimum of 10 and a maximum of 50 papules and/or pustules, persistent erythema, and telangiectasia
    - Ability and willingness to accept and comply with treatment and required medical examinations
  • - Known non-responders to azelaic acid
    - Erythematotelangiectatic, rhinophymatous, ocular, or steroid rosacea
    - Presence of dermatoses that could interfere with the rosacea diagnosis
    - Treatment with isotretinoin in the six months prior to randomization
    - Treatment of the face with topical retinoids during the two weeks prior to randomization
    - Treatment with oral antibiotics during the four weeks prior to randomization
    - Treatment with topical antibiotics
    - Treatment with systemic corticosteroids during 4 weeks prior to randomization
    - Treatment of the face with topical corticosteroids during 2 weeks prior to randomization
    - Treatment of the face with topical imidazole antimycotics during 2 weeks prior to randomization
    - Treatment of the face with topical azelaic acid formulations during 2 weeks prior to randomization
    - Use of a sauna during 2 weeks prior to randomization and during the study
    - Facial laser surgery for telangiectasia during 6 weeks prior to randomization
    - Planned concurrent use of any treatment other than study medication that affects rosacea
    - History of hypersensitivity to propylene glycol or any other ingredient of the study drugs
    - Participation in another clinical trial during the last 4 weeks

Trial summary

Enrollment Goal
83
Trial Dates
January 2008 - June 2008
Phase
Phase 2
Could I Receive a placebo
No
Products
Finacea® (azelaic acid) Foam, 15% (Azelaic Acid, BAY39-6251)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Henderson, 89052, United States
Completed
Mason, 45040, United States
Completed
Cherry Creek Research, IncDenver, 80209, United States
Completed
VCR OfficeNorfolk, 23507, United States
Completed
Compliant Clinical ResearchOlathe, 66062, United States
Completed
Academic DermatologyAlbuquerque, 87106, United States
Completed
Derm Research, IncAustin, 78759, United States

Primary Outcome

  • Nominal change from baseline in inflammatory lesion (IL) count (sum of papules and pustules) per participant at End of Study (LOCF: last observation carried forward)
    date_rangeTime Frame:
    Baseline and End of Study (Week 12)
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with Investigator’s Global Assessment (IGA) based therapeutic success at End of Study (LOCF)
    date_rangeTime Frame:
    At End of Study (Week 12)
    enhanced_encryption
    Safety Issue:
    No
  • Grouped change from baseline in erythema intensity score at End of Study (LOCF)
    date_rangeTime Frame:
    Baseline and End of Study (Week 12)
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Mean of inflammatory lesion count per participant at Weeks 4, 8, 12 and End of Study (LOCF)
    date_rangeTime Frame:
    At Weeks 4, 8, 12 and End of Study (LOCF)
    enhanced_encryption
    Safety Issue:
    No
  • Nominal change from baseline in inflammatory lesion count per participant at Weeks 4, 8 and 12
    date_rangeTime Frame:
    Baseline and Weeks 4, 8 and 12
    enhanced_encryption
    Safety Issue:
    No
  • Percent change from baseline in inflammatory lesion count per participant at Weeks 4, 8, 12 and End of Study (LOCF)
    date_rangeTime Frame:
    Baseline and Weeks 4, 8, 12 and End of Study (LOCF)
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with respective disease severity measured by IGA scores at Weeks 4, 8, 12 and End of Study (LOCF)
    date_rangeTime Frame:
    At Weeks 4, 8, 12 and End of Study (LOCF)
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in IGA scores at Weeks 4, 8, 12 and End of Study (LOCF)
    date_rangeTime Frame:
    Baseline and Weeks 4, 8, 12 and End of Study (LOCF)
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with erythema intensity scores at Weeks 4, 8, 12 and End of Study (LOCF)
    date_rangeTime Frame:
    At Weeks 4, 8, 12 and End of Study (LOCF)
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in erythema intensity scores at Weeks 4, 8, 12 and End of Study (LOCF)
    date_rangeTime Frame:
    Baseline and Weeks 4, 8, 12 and End of Study (LOCF)
    enhanced_encryption
    Safety Issue:
    No
  • Grouped change from baseline in erythema intensity score at Weeks 4, 8 and 12
    date_rangeTime Frame:
    Baseline and Weeks 4, 8 and 12
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with telangiectasia intensity scores at Weeks 4, 8, 12 and End of Study (LOCF)
    date_rangeTime Frame:
    At Weeks 4, 8, 12 and End of Study (LOCF)
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in telangiectasia intensity scores at Weeks 4, 8, 12 and End of Study (LOCF)
    date_rangeTime Frame:
    Baseline and Weeks 4, 8, 12 and End of Study (LOCF)
    enhanced_encryption
    Safety Issue:
    No
  • Grouped change from baseline in telangiectasia intensity scores at Weeks 4, 8, 12 and End of Study (LOCF)
    date_rangeTime Frame:
    Baseline and Weeks 4, 8, 12 and End of Study (LOCF)
    enhanced_encryption
    Safety Issue:
    No
  • Investigator’s rating of overall improvement at End of Study (LOCF)
    date_rangeTime Frame:
    At End of Study (Week 12)
    enhanced_encryption
    Safety Issue:
    No
  • Patients’ rating of overall improvement at End of Study (LOCF)
    date_rangeTime Frame:
    At End of Study (Week 12)
    enhanced_encryption
    Safety Issue:
    No
  • Patients’ opinion on cosmetic acceptability at End of Study (LOCF)
    date_rangeTime Frame:
    At End of Study (Week 12)
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with IGA based therapeutic success at Weeks 4, 8 and 12
    date_rangeTime Frame:
    At Weeks 4, 8 and 12
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with IGA based patient response at Weeks 4, 8, 12 and End of Study (LOCF)
    date_rangeTime Frame:
    At Weeks 4, 8, 12 and End of Study (LOCF)
    enhanced_encryption
    Safety Issue:
    No

Trial design

A 12-week exploratory, multicenter, double-blind, vehicle-controlled study to investigate the efficacy and safety of topical azelaic acid 15% foam twice daily in patients with papulopustular rosacea
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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