NCT00617903已完成2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 83
- 主要终点
- 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)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Azelaic acid foam, 15% (BAY39-6251)
Experimental
Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
干预措施: Azelaic acid (Drug)
Vehicle foam
Placebo Comparator
Participants received vehicle foam topically twice daily for 12 weeks
干预措施: Vehicle foam (Drug)
结局指标
主要结局
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)
时间窗: Baseline and End of Study (Week 12)
Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Study (LOCF)
时间窗: 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)
时间窗: Baseline and End of Study (Week 12)
Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe
次要结局
- Nominal Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8 and 12(Baseline and Weeks 4, 8 and 12)
- Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)(At Weeks 4, 8, 12 and End of Study (LOCF))
- Change From Baseline in IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)(Baseline and Weeks 4, 8, 12 and End of Study (LOCF))
- Mean of Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF)(At Weeks 4, 8, 12 and End of Study (LOCF))
- Percent Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF)(Baseline and Weeks 4, 8, 12 and End of Study (LOCF))
- Grouped Change From Baseline in Erythema Intensity Score at Weeks 4, 8 and 12(Baseline and Weeks 4, 8 and 12)
- Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)(At Weeks 4, 8, 12 and End of Study (LOCF))
- Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)(Baseline and Weeks 4, 8, 12 and End of Study (LOCF))
- Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)(Baseline and Weeks 4, 8, 12 and End of Study (LOCF))
- Investigator's Rating of Overall Improvement at End of Study(At End of Study (Week 12))
- Patients' Rating of Overall Improvement at End of Study(At End of Study (Week 12))
- Patients' Opinion on Cosmetic Acceptability at End of Study(At End of Study (Week 12))
- Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)(At Weeks 4, 8, 12 and End of Study (LOCF))
- Change From Baseline in Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)(Baseline and Weeks 4, 8, 12 and End of Study (LOCF))
- Percentage of Participants With IGA Based Therapeutic Success at Weeks 4, 8 and 12(At Weeks 4, 8 and 12)
- Percentage of Participants With IGA Based Patient Response at Weeks 4, 8, 12 and End of Study (LOCF)(At Weeks 4, 8, 12 and End of Study (LOCF))
研究者
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