Exploration of Safety and Efficacy of AzA 15% Foam Twice a Day in Rosacea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00617903
First received: January 22, 2008
Last updated: December 26, 2013
Last verified: December 2013
  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.


Condition Intervention Phase
Papulopustular Rosacea
Drug: Azelaic acid
Drug: Vehicle foam
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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) [ Time Frame: Baseline and End of Study (Week 12) ] [ Designated as safety issue: No ]
  • Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Study (LOCF) [ Time Frame: At End of Study (Week 12) ] [ Designated as safety issue: No ]
    IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success is defined as an IGA score of clear or minimal (0 to 1).

  • Grouped Change From Baseline in Erythema Intensity Score at End of Study (LOCF) [ Time Frame: Baseline and End of Study (Week 12) ] [ Designated as safety issue: No ]
    Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe


Secondary Outcome Measures:
  • Mean of Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF) [ Time Frame: At Weeks 4, 8, 12 and End of Study (LOCF) ] [ Designated as safety issue: No ]
  • Nominal Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8 and 12 [ Time Frame: Baseline and Weeks 4, 8 and 12 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF) [ Time Frame: Baseline and Weeks 4, 8, 12 and End of Study (LOCF) ] [ Designated as safety issue: No ]
  • Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) [ Time Frame: At Weeks 4, 8, 12 and End of Study (LOCF) ] [ Designated as safety issue: No ]
    IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success is defined as an IGA score of clear or minimal (0 to 1).

  • Change From Baseline in IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) [ Time Frame: Baseline and Weeks 4, 8, 12 and End of Study (LOCF) ] [ Designated as safety issue: No ]
    IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success is defined as an IGA score of clear or minimal (0 to 1).

  • Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) [ Time Frame: At Weeks 4, 8, 12 and End of Study (LOCF) ] [ Designated as safety issue: No ]
    Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe

  • Change From Baseline in Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) [ Time Frame: Baseline and Weeks 4, 8, 12 and End of Study (LOCF) ] [ Designated as safety issue: No ]
    Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe

  • Grouped Change From Baseline in Erythema Intensity Score at Weeks 4, 8 and 12 [ Time Frame: Baseline and Weeks 4, 8 and 12 ] [ Designated as safety issue: No ]
    Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe

  • Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) [ Time Frame: At Weeks 4, 8, 12 and End of Study (LOCF) ] [ Designated as safety issue: No ]
    Telangiectasia intensity score: 1 - None; 2 - Mild; 3 - Moderate; 4 - Severe

  • Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) [ Time Frame: Baseline and Weeks 4, 8, 12 and End of Study (LOCF) ] [ Designated as safety issue: No ]
    Telangiectasia intensity score: 1 - None; 2 - Mild; 3 - Moderate; 4 - Severe

  • Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) [ Time Frame: Baseline and Weeks 4, 8, 12 and End of Study (LOCF) ] [ Designated as safety issue: No ]
    Telangiectasia intensity score: 1 - None; 2 - Mild; 3 - Moderate; 4 - Severe

  • Investigator's Rating of Overall Improvement at End of Study [ Time Frame: At End of Study (Week 12) ] [ Designated as safety issue: No ]
    Investigator's rating of overall improvement: 1 - excellent improvement; 2 - marked improvement; 3 - moderate improvement; 4 - no change; 5 - deterioration

  • Patients' Rating of Overall Improvement at End of Study [ Time Frame: At End of Study (Week 12) ] [ Designated as safety issue: No ]
    Patient's rating of overall improvement: 1 - excellent; 2 - good; 3 - fair; 4 - no improvement; 5 - worse

  • Patients' Opinion on Cosmetic Acceptability at End of Study [ Time Frame: At End of Study (Week 12) ] [ Designated as safety issue: No ]
    Patient's opinion on cosmetic acceptability: 1 - very good; 2 - good; 3 - satisfactory; 4 - poor; 5 - no opinion

  • Percentage of Participants With IGA Based Therapeutic Success at Weeks 4, 8 and 12 [ Time Frame: At Weeks 4, 8 and 12 ] [ Designated as safety issue: No ]
  • Percentage of Participants With IGA Based Patient Response at Weeks 4, 8, 12 and End of Study (LOCF) [ Time Frame: At Weeks 4, 8, 12 and End of Study (LOCF) ] [ Designated as safety issue: No ]

Enrollment: 83
Study Start Date: January 2008
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Azelaic acid foam, 15% (BAY39-6251)
Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
Drug: Azelaic acid
15% foam to be applied topically twice daily
Placebo Comparator: Vehicle foam
Participants received vehicle foam topically twice daily for 12 weeks
Drug: Vehicle foam
Active-ingredient-free vehicle to be applied topically twice daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00617903

Locations
United States, Colorado
Denver, Colorado, United States, 80209
United States, Kansas
Olathe, Kansas, United States, 66062
United States, Nevada
Henderson, Nevada, United States, 89052
United States, New Mexico
Albuquerque, New Mexico, United States, 87106
United States, Ohio
Mason, Ohio, United States, 45040
United States, Texas
Austin, Texas, United States, 78759
United States, Virginia
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00617903     History of Changes
Other Study ID Numbers: 1402140
Study First Received: January 22, 2008
Results First Received: May 2, 2013
Last Updated: December 26, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
rosacea
papulopustular
azelaic acid
foam

Additional relevant MeSH terms:
Rosacea
Skin Diseases
Azelaic acid
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents

ClinicalTrials.gov processed this record on September 16, 2014