NCT02583009已完成2 期
Multicenter, Randomized, Double-blind, Placebo-controlled Parallel-group, Dose Finding Phase II Clinical Trial to Evaluate Anti Rosacea Effect and Safety of PAC-14028 Cream (0.1%, 0.3%, 1.0%) in Rosacea Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- Change in Investigator Global Assessment (IGA)
研究概览
简要总结
This clinical study is to determine the optimum dose of PAC-14028 cream in a therapeutic confirmatory clinical study by evaluating the safety and therapeutic equivalence of PAC-14028 cream 0.1%, 0.3% and 1.0% in patients with rosacea.
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
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients aged 19 - 70 years old
- •Among the patients diagnosed with erythematotelangiectatic and papulopustular rosacea in accordance with the diagnostic criteria of the National Rosacea Society Expert Committee
- •Subjects with rosacea scored 2 or more according to the Investigator Global Assessment (IGA) at screening
排除标准
- •Those who can't be diagnosed or assessed for rosacea due to the presence of trauma, tattoo, scar, excessive hairs on the facial region
- •Those who have received a facial laser treatment within 6 weeks
- •Those who have been administered with oral retinoid or therapeutic vitamin A within 6 months
- •Those who have received a hormonal treatment such as estrogen within 3 months
- •Those who have been administered with systemic antibiotics or systemic steroid formulation within 4 weeks
- •Those who have been administered with local retinoid, local steroid and local antibiotics and local medication for the treatment of rosacea on face within 4 weeks
- •Those who have a history of blood disorder that can have a serious effect on the clinical study
- •Women who are pregnant, lactating or who plan to be pregnant during the clinical study period or women of childbearing potential who do not use available contraceptive methods
研究组 & 干预措施
PAC-14028 cream 0.1%
Experimental
PAC-14028 cream 0.1%, Twice daily for 4 weeks
干预措施: PAC-14028 cream 0.1% (Drug)
PAC-14028 cream 0.3%
Experimental
PAC-14028 cream 0.3%, Twice daily for 4 weeks
干预措施: PAC-14028 cream 0.3% (Drug)
PAC-14028 cream 1.0%
Experimental
PAC-14028 cream 1.0%, Twice daily for 4 weeks
干预措施: PAC-14028 cream 1.0% (Drug)
PAC-14028 cream vehicle
Placebo Comparator
PAC-14028 cream vehicle, Twice daily for 4 weeks
干预措施: PAC-14028 cream vehicle (Drug)
结局指标
主要结局
Change in Investigator Global Assessment (IGA)
时间窗: Week 4 from the baseline
Any intragroup and intergroup differences with respect to the IGA difference value on 28th day from the baseline.
次要结局
- Improvement rate in Investigator Global Assessment (IGA)(Week 4 from the baseline)
- Change in the erythema severity score(Week 4 from the baseline)
- Rate of change in inflammatory lesion counts(Week 4 from the baseline)
- Change in erythema index(Week 4 from the baseline)
- Change in the telangiectasia severity score(Week 4 from the baseline)
研究者
研究点 (1)
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