A Phase 4, Open-Label, Multicenter, Community-based, 12-Week Trial Assessment of Effectiveness, Safety, and Subject Satisfaction With Oracea® [Doxycycline, USP] Capsules 40 mg (30 mg Immediate Release & 10 mg Delayed Release Beads) When Used as Monotherapy or as Add-On Therapy to Existing Topical Regimens for the Treatment of Rosacea
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 1,421
- 试验地点
- 1
- 主要终点
- Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint
研究概览
简要总结
The objective of this study is to assess the effectiveness, safety, subject satisfaction and quality of life with Oracea® when used as monotherapy or as add-on therapy to existing topical regimens for the treatment of rosacea.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Males and females aged 18 and older
- •Subjects with diagnosis of rosacea (IGA of 2 to 4)
排除标准
- •Subjects who used a topical or systemic acne treatment within 4 months of the baseline visit (retinoids and isotretinoin)
- •Subjects who used a topical or systemic antibiotic within 4 weeks of the baseline visit
- •Subjects who had laser or IPL (intense pulsed light) treatments within 3 months of the baseline visit and/or who plan to have these treatments during the study
- •Subjects who have a known hypersensitivity to tetracyclines or ingredients of the add on medications
- •Subjects who have stomach or GI problems, kidney disease or have an active systemic fungal infection or a vaginal yeast infection are excluded
研究组 & 干预措施
Oracea® as monotherapy
Oracea as monotherapy
干预措施: doxycycline (Oracea®) 40 mg modified release as monotherapy (Drug)
Oracea® as add-on therapy
Oracea® as add-on Therapy (Oracea® + Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides
干预措施: doxycycline (Oracea®) 40 mg modified release as add-on therapy (Drug)
结局指标
主要结局
Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint
时间窗: Baseline to Week 12
Number of participants with a change (Week 12 minus Baseline) in Investigator's Global Assessment (IGA) score. IGA is measured on a scale from 0 - 4 with 0 = Clear; 1 = Near Clear; 2 = Mild; 3 = Moderate; and 4 = Severe. Results values (+4, +3, +2, +1, 0, -1, -2, -3, -4) represent change from Baseline to Week 12.
次要结局
- Change in Clinician's Erythema Assessment Scale (CEA) Score From Baseline to Endpoint(Baaseline to Week 12)
- Number of Treatment Responders at Endpoint, Where Response is Defined as an IGA Score of 0 (Clear) or 1 (Near Clear)(Baseline to Week 12)