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临床试验/NCT05045469
NCT05045469已完成2 期

Therapeutic Effects of Topical Herbal Medicine on Rosacea

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2021年8月4日最近更新:
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
入组人数
24
试验地点
1
主要终点
Reduction of Flushing, Erythema, Telangiectasia, Papules, and Pustules

研究概览

简要总结

The aim of this study is to investigate the effects of topical herbal medicine in the patients with rosacea.

详细描述

Rosacea is a chronic inflammatory disorder which affects the cheek, nose, chin, forehead and eyes. It is typically characterized by cutaneous signs such as flushing, erythema, telangiectasia, papules, and pustules in the face. The pathogenic mechanism of rosacea is unknown, and there is no cure for rosacea. The therapeutic approaches include oral medicine, topical medicine and surgical interventions depending on the different subtypes of rosacea. The recent study demonstrates that combination therapy may be more effectively improved the symptoms of rosacea. Dian dao san is a topical herbal compound for reducing the features as flushing, erythema, papules, and pustules for years. The investigators hypothesize that dian dao san can be more beneficial in treating the patients with rosacea and improving the quality of life.

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
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Willing to sign inform consent
  • Aged above 20 years old with rosacea
  • No treatment for rosacea within 2 weeks

排除标准

  • With malignant lesion in the rosacea lesion
  • Rosacea lesion with high risk of infection
  • Allergy to Chinese herbal medicine patch or ointment
  • Pregnancy

研究组 & 干预措施

group A (dian dao san group)

Active Comparator

Herbal medicine (dian dao san) will be applied to the lesions of rosacea twice a day. Subject will receive persistent treatment for 6 weeks.

干预措施: dian dao san (Drug)

group B( topical medicine without therapeutic effects)

Placebo Comparator

Placebo (topical medicine without therapeutic effects) will be applied to the lesions of rosacea twice a day. Subject will receive persistent treatment for 6 weeks.

干预措施: dian dao san (Drug)

结局指标

主要结局

Reduction of Flushing, Erythema, Telangiectasia, Papules, and Pustules

时间窗: 6 weeks

quantified by Investigator Global Assessment, IGA. IGA is used in the study for assessing the severity of rosacea ranging from 0 (clean) to 4 (most severe).

次要结局

  • Dermatology Quality of Life Index, DQoL(6 weeks)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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