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The aim of this study is to investigate the effects of topical herbal medicine in the patients with rosacea.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dian dao san | Drug | dian dao san and placebo will be used in the rosacea lesions twice a day for 6 weeks |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Dermatology Quality of Life Index, DQoL | DQoL is a questionnaire-based scale designed to measure the impact of dermatological conditions on a patient's quality of life. It assesses various aspects, including symptoms, psychological well-being, social activities, and treatment-related effects. Scale Range:The DQoL consists of 10 questions, each scored on a scale from 0 to 3: 0 = Not at all, 1 = A little,2 = A lot,3 = Very much The total score ranges from 0 to 30, where higher scores indicate a greater negative impact of the skin condition on quality of life. Interpretation of Scale Scores: Total Score 0-1: No or minimal impact; 2-5: Mild impact; 6-10: Moderate impact; 11-20: Significant impact; 21-30: Severe impact Higher DQoL scores indicate worse quality of life due to the skin condition, while lower scores suggest minimal impact. Computation of Scores:DQoL total score is calculated as the sum of the 10 item scores. Unit of Measure: "Scores on a scale" should be used as the Unit of Measure if no other units apply. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| YUAN-CHIEH YEH, Doctor | Chang Gung Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keelung Chang Gung Memorial Hospital | Keelung | Taiwan |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A (Dian Dao San Group) | Herbal medicine (dian dao san) will be applied to the lesions of rosacea twice a day. Subject will receive persistent treatment for 6 weeks. dian dao san: dian dao san and placebo will be used in the rosacea lesions twice a day for 6 weeks |
| FG001 | Group B( Topical Medicine Without Therapeutic Effects) | 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. dian dao san: dian dao san and placebo will be used in the rosacea lesions twice a day for 6 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A (Dian Dao San Group) | Herbal medicine (dian dao san) will be applied to the lesions of rosacea twice a day. Subject will receive persistent treatment for 6 weeks. dian dao san: dian dao san and placebo will be used in the rosacea lesions twice a day for 6 weeks |
| BG001 | Group B( Topical Medicine Without Therapeutic Effects) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
|
6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A (Dian Dao San Group) | Herbal medicine (dian dao san) will be applied to the lesions of rosacea twice a day. Subject will receive persistent treatment for 6 weeks. dian dao san: dian dao san and placebo will be used in the rosacea lesions twice a day for 6 weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. HuanHsuan Hsu | CGMH | 0978839349 | 10356017a@cgmh.org.tw |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 12, 2025 | Mar 13, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| 6 weeks |
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. dian dao san: dian dao san and placebo will be used in the rosacea lesions twice a day for 6 weeks |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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| Secondary | Dermatology Quality of Life Index, DQoL | DQoL is a questionnaire-based scale designed to measure the impact of dermatological conditions on a patient's quality of life. It assesses various aspects, including symptoms, psychological well-being, social activities, and treatment-related effects. Scale Range:The DQoL consists of 10 questions, each scored on a scale from 0 to 3: 0 = Not at all, 1 = A little,2 = A lot,3 = Very much The total score ranges from 0 to 30, where higher scores indicate a greater negative impact of the skin condition on quality of life. Interpretation of Scale Scores: Total Score 0-1: No or minimal impact; 2-5: Mild impact; 6-10: Moderate impact; 11-20: Significant impact; 21-30: Severe impact Higher DQoL scores indicate worse quality of life due to the skin condition, while lower scores suggest minimal impact. Computation of Scores:DQoL total score is calculated as the sum of the 10 item scores. Unit of Measure: "Scores on a scale" should be used as the Unit of Measure if no other units apply. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Group B( Topical Medicine Without Therapeutic Effects) | 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. dian dao san: dian dao san and placebo will be used in the rosacea lesions twice a day for 6 weeks | 0 | 12 | 0 | 12 | 0 | 12 |
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