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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Papulopustular Rosacea | Drug: Azelaic acid Drug: Vehicle foam | Phase 2 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Azelaic acid foam, 15% (BAY39-6251)
Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
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Drug: Azelaic acid
15% foam to be applied topically twice daily
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Placebo Comparator: Vehicle foam
Participants received vehicle foam topically twice daily for 12 weeks
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Drug: Vehicle foam
Active-ingredient-free vehicle to be applied topically twice daily
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- 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) ]
- 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).
- 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
- 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) ]
- 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 ]
- 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) ]
- 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).
- 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).
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- Percentage of Participants With IGA Based Therapeutic Success at Weeks 4, 8 and 12 [ Time Frame: At Weeks 4, 8 and 12 ]
- 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) ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
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 |
Study Director: | Bayer Study Director | Bayer |
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 |