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

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ClinicalTrials.gov Identifier: NCT00617903
Recruitment Status : Completed
First Posted : February 18, 2008
Results First Posted : July 4, 2013
Last Update Posted : January 31, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Papulopustular Rosacea Drug: Azelaic acid Drug: Vehicle foam Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : January 2008
Primary Completion Date : June 2008
Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rosacea
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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) ]
  2. 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) ]
    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).

  3. Grouped Change From Baseline in Erythema Intensity Score at End of Study (LOCF) [ Time Frame: Baseline and End of Study (Week 12) ]
    Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe


Secondary Outcome Measures :
  1. 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) ]
  2. 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 ]
  3. 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) ]
  4. 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) ]
    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).

  5. 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) ]
    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).

  6. 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) ]
    Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe

  7. 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) ]
    Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe

  8. Grouped Change From Baseline in Erythema Intensity Score at Weeks 4, 8 and 12 [ Time Frame: Baseline and Weeks 4, 8 and 12 ]
    Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe

  9. 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) ]
    Telangiectasia intensity score: 1 - None; 2 - Mild; 3 - Moderate; 4 - Severe

  10. 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) ]
    Telangiectasia intensity score: 1 - None; 2 - Mild; 3 - Moderate; 4 - Severe

  11. 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) ]
    Telangiectasia intensity score: 1 - None; 2 - Mild; 3 - Moderate; 4 - Severe

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

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

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

  15. Percentage of Participants With IGA Based Therapeutic Success at Weeks 4, 8 and 12 [ Time Frame: At Weeks 4, 8 and 12 ]
  16. 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) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00617903     History of Changes
Other Study ID Numbers: 1402140
First Posted: February 18, 2008    Key Record Dates
Results First Posted: July 4, 2013
Last Update Posted: January 31, 2014
Last Verified: December 2013

Keywords provided by Bayer:
rosacea
papulopustular
azelaic acid
foam

Additional relevant MeSH terms:
Rosacea
Skin Diseases
Azelaic acid
Antineoplastic Agents
Dermatologic Agents