A Randomized, Double-blind, Vehicle-controlled, Multicenter, Parallel-group Clinical Trial to Assess the Safety and Efficacy of Azelaic Acid Foam, 15% Topically Applied Twice Daily for 12 Weeks in Subjects With Papulopustular Rosacea
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 961
- 主要终点
- Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Treatment (LOCF: Last Observation Carried Forward)
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of azelaic acid (AzA) foam, 15% topically applied twice daily for 12 weeks in subjects with papulopustular rosacea compared to its vehicle.
详细描述
To determine the efficacy of AzA foam, 15% compared to vehicle topically applied twice daily in papulopustular rosacea evaluated by therapeutic success rate according to Investigators Global Assessment (IGA) and change in inflammatory lesion count from baseline to end of treatment.
Evaluation of all adverse events will be covered in Adverse Events section.
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
- Double (Participant, Investigator)
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
- •Diagnosis of papulopustular rosacea
- •Free of any clinically significant disease, which could interfere with the study
- •Male or female subject aged ≥ 18 years
- •Willingness of subject to follow all study procedures
- •Signed written informed consent before any study-related activities are carried out
排除标准
- •Subjects who are known to be non-responders to azelaic acid
- •Presence of dermatoses that might interfere with rosacea diagnosis
- •Ocular rosacea; phymatous rosacea; subjects with plaque-type rosacea lesions, papulopustular rosacea that requires systemic treatment
- •Topical use of any prescription or non-prescription medication to treat rosacea within 6 weeks prior to randomization and throughout the study
- •Systemic use of any prescription or non-prescription medication to treat rosacea (Retinoids within 6 months, Tetracycline within 2 months, Corticosteroids, erythromycin, azithromycin, and/or metronidazole within 4 weeks) prior to randomization and throughout the study
- •Facial laser surgery for telangiectasia (or other conditions) within 6 weeks prior to randomization
- •Known hypersensitivity to any ingredients of the investigational product formulation
- •Participation in another clinical research in parallel or within the last 4 weeks before randomization in this study
- •Any condition or therapy that in the investigator's opinion may pose a risk to the subject or that could interfere with any evaluation in the study
研究组 & 干预措施
Azelaic acid foam, 15% (BAY39-6251)
0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
干预措施: Azelaic acid foam, 15% (BAY39-6251) (Drug)
Vehicle foam
0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
干预措施: Vehicle foam (Drug)
结局指标
主要结局
Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Treatment (LOCF: Last Observation Carried Forward)
时间窗: At end of treatment (LOCF), up to 12 weeks
Static evaluation of overall severity of papulopustular rosacea at a given time: 1) Clear: no papules and/or pustules; no erythema; 2) Minimal: rare papules and/or pustules; faint up to but not including mild erythema; 3) Mild: few papules and/or pustules; mild erythema; 4) Moderate: pronounced number of papules and/or pustules (but less than numerous papules and/or pustules); moderate erythema; 5) Severe: numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate to severe erythema. Therapeutic success is defined as an IGA score of clear or minimal.
Nominal Change From Baseline in Inflammatory Lesion (IL) Count at End of Treatment (LOCF)
时间窗: Baseline and end of treatment (LOCF), up to 12 weeks
The mean (standard deviation) change from baseline in the inflammatory lesion count at the end of treatment is provided.
次要结局
- Percentage of Participants With Erythema Intensity Score at End of Treatment (LOCF)(At end of treatment (LOCF), up to 12 weeks)
- Percent Change From Baseline in Inflammatory Lesion Count at End of Treatment (LOCF)(Baseline and end of treatment (LOCF), up to 12 weeks)
- Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Response at End of Treatment (LOCF)(At end of treatment (LOCF), up to 12 weeks)
- Grouped Changes From Baseline in Erythema Intensity Score at End of Treatment (LOCF)(Baseline and end of treatment (LOCF), up to 12 weeks)
- Percentage of Participants With Investigator's Global Assessment (IGA) Scores at End of Treatment (LOCF)(At end of treatment (LOCF), up to 12 weeks)
- Nominal Value of Inflammatory Lesion Count at End of Treatment (LOCF)(At end of treatment (LOCF), up to 12 weeks)
- Grouped Changes From Baseline in Telangiectasia Intensity Score at End of Treatment (LOCF)(Baseline and end of treatment (LOCF), up to 12 weeks)
- Percentage of Participants With Facial Skin Color Rating at End of Treatment (LOCF)(At end of treatment (LOCF), up to 12 weeks)
- Participants' Global Assessment of Treatment Response at End of Treatment(At end of treatment, up to 12 weeks)
- Participants' Global Assessment of Tolerability at End of Treatment(At end of treatment, up to 12 weeks)
- Participants' Opinion on Cosmetic Acceptability at End of Treatment(At end of treatment, up to 12 weeks)
- Participants' Opinion on Practicability of Product Use in Facial Areas Next to the Hairline at End of Treatment(At end of treatment, up to 12 weeks)
- Change From Baseline in Rosacea Quality of Life (RosaQoL) Questionnaire at End of Treatment - Overall Quality of Life Score(Baseline and end of treatment, up to 12 weeks)
- Number of Participants With Change From Baseline in Dermatology Life Quality Index (DLQI) Questionnaire at End of Treatment - Overall Score(Baseline and end of treatment, up to 12 weeks)
- Change From Baseline in EuroQol Group Questionnaire-Visual Analogue Scale (EQ-VAS) at End of Treatment(Baseline and end of treatment, up to 12 weeks)
- Change From Baseline in Index Value at End of Treatment(Baseline and end of treatment, up to 12 weeks)