Therapeutic Effects of Topical Herbal Medicine -Rhubarb Ointment on Rosacea

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

Detailed Description
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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.

Official Title
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Therapeutic Effects of Topical Herbal Medicine on Rosacea

Conditions
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Rosacea, Chinese Herbal Medicine

Intervention / Treatment
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* Drug: dian dao san


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing to sign inform consent Aged above 20 years old with rosacea No treatment for rosacea within 2 weeks Exclusion Criteria: With malignant lesion in the rosacea lesion Rosacea lesion with high risk of infection Allergy to Chinese herbal medicine patch or ointment Pregnancy

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group A (dian dao san group)<br>Herbal medicine (dian dao san) will be applied to the lesions of rosacea twice a day. Subject will receive persistent treatment for 6 weeks. | Drug: dian dao san<br>* dian dao san and placebo will be used in the rosacea lesions twice a day for 6 weeks<br>|
| Placebo Comparator: group B( topical medicine without therapeutic effects)<br>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. | Drug: dian dao san<br>* dian dao san and placebo will be used in the rosacea lesions twice a day for 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction of flushing, erythema, telangiectasia, papules, and pustules | 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). | 6 weeks | 
| absence of adverse skin reaction to topical medicine | scored with Dyshidrotic Eczema Area and Severity Index (DASI index). The total score of the DASI results from the sum of severity grade score points of each of the four items (V = vesicles, E = erythema, S = desquamation, I = itch) multiplied by the affected area (A) score points: DASI = (pV + pE + pS + pI) × pA. The maximum possible score is 60. By the DASI, the dyshidrotic eczema is graded as: mild (0-15), moderate (16-30) and severe (31-60). | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement of life quality | Dermatology Quality of Life Index, DQoL is the questionnaire which designed to measure the health-related quality of life of adult patients suffering from a skin disease ranging from 0(no effect at all on patient's life) to 30(extremely large effect on patient's life). | 6 weeks |