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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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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
Actual Primary Completion Date :	June 2008
Actual Study Completion Date :	June 2008

Arms and Interventions

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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

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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

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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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

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Responsible Party:	Bayer
ClinicalTrials.gov Identifier:	NCT00617903 History of Changes
Other Study ID Numbers:	1402140
First Posted:	February 18, 2008
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