NCT02052999已完成2 期
An Open Label Pilot Study to Evaluate the Efficacy of PAC-14028 in the Treatment of Erythematotelangiectatic Rosacea and 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
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Investigator Global Assessment (IGA)
研究概览
简要总结
The objective of this study is to determine the efficacy and safety of PAC-14028 1% cream of Amorepacific Corporation in patients with erythema-telangiectatic or papulopustular 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
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients at the age of 20 to 65 years old
- •Clinical diagnosis of erythematotelangiectatic or papulopustular rosacea according to National Rosacea Committee Expert Society with
- •Erythema severity ≥ 1
- •Telangiectasia severity ≥ 1
- •At least 3 papules or pustules in facial region
- •IGA score ≥ 2
- •Voluntarily signed written informed consent forms for study participation
排除标准
- •Patients who are unable to be diagnosed or evaluated for rosacea due to tattoo or scar in the facial area
- •Patients who are unable to be diagnosed or evaluated for rosacea due to excess hair(e.g., mustache, beard, whiskers etc.) in the facial area
- •Patients who are sensitive to the drug or vehicle
- •Previous administration of oral retinoid or vitamin A(≥10,000 units/day) within 6 months prior to visit 1
- •Previous use of estrogen or oral contraceptives within 3 months prior to visit 1
- •Previous use of topical retinoids or oral antibiotics (e.g., tetracycline, tetracycline derivatives, erythromycin, erythromycin derivatives, sulfamethoxazole, trimethoprim) or oral steroid for the treatment of facial rosacea within 1 month prior to visit 1
- •Previous use of topical steroid or topical antibiotics, topical treatment for rosacea(e.g., metronidazole, azelaic acid) within 2 weeks prior to visit 1
- •Presently undergoing anti-coagulant therapies
- •History of hematologic disease
- •Ocular-only, Phymatous rosacea, or papulopustular rosacea patients who require systemic antibiotics
- •History of laser treatment for rosacea within 6 weeks prior to visit 1
- •Alcoholic or drug abuse patients
- •Patients who are treated with prohibited concomitant drugs or considered to inevitably require treatment with prohibited concomitant drugs during the study period
- •Renal function impairment with creatinine level higher than twice of maximum normal range
- •Hepatic function impairment with AST/ALT higher than twice of maximum normal range
- •Pregnant and lactating woman, woman with child-birth potential(should have negative pregnancy test at the baseline visit of the study)
- •Participation in another clinical study within 1 month prior to screening
- •Patients considered ineligible for study participation by the principal investigator or sub-investigator for other reasons; rosacea due to other medical (liver disease, renal failure, etc.), psychotic, or neuropathic causes rather than as a skin disease
研究组 & 干预措施
Vehicle
Placebo Comparator
Vehicle, twice daily for 8 weeks
干预措施: Vehicle (Other)
Rozex gel 0.75%
Active Comparator
Rozex gel 0.75%, twice daily for 8 weeks
干预措施: Rozex gel 0.75% (Drug)
PAC-14028 cream 1%
Experimental
PAC-14028 cream 1%, twice daily for 8 weeks
干预措施: PAC-14028 cream 1% (Drug)
结局指标
主要结局
Change in Investigator Global Assessment (IGA)
时间窗: Baseline through Study Week 8
次要结局
- Erythema severity(Baseline through Study Week 8)
- Telangiectasia severity(Baseline through Study Week 8)
- Inflammatory lesion counts(Baseline through Study Week 8)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Open Label Pilot Study of Perampanel for the Treatment of Alcohol Use DisorderAlcohol DisordersNCT04502589Virginia Commonwealth University4
进行中（未招募）
4 期
Clinical Study to Assess the Efficacy and Safety of Olaparib in Chinese Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Prior Treatment With a New Hormonal Agent and Have BRCA1/2 MutationsMetastatic Castration-resistant Prostate CancerNCT05457257AstraZeneca43
Unknown
2 期
Efficacy and Tolerability of Ecopipam in Adults With Childhood Onset Fluency Disorder (Stuttering).Communication DisorderStuttering, AdultSpeech DisordersLanguage DisordersChildhood-onset Fluency DisorderNCT02909088Gerald Maguire, MD10
终止
不适用
A Study to Evaluate the Safety and Efficacy of Apremilast in the Treatment of Skin Disease in Patients With DermatomyositisDermatomyositisNCT01140503Stanford University5
终止
2 期
MMV390048 POC in Patients With P. Vivax and P. Falciparum MalariaMalariaNCT02880241Medicines for Malaria Venture8