Chinese Herbal Medicine, Rosacea
Conditions
Brief summary
The aim of this study is to investigate the effects of topical herbal medicine in the patients with rosacea.
Detailed description
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.
Interventions
DRUGdian dao san
dian dao san and placebo will be used in the rosacea lesions twice a day for 6 weeks
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of Flushing, Erythema, Telangiectasia, Papules, and Pustules | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dermatology Quality of Life Index, DQoL | 6 weeks | 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. |
Countries
Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 12 |
| 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 | 12 |
| Total | 24 |
Baseline characteristics
| Characteristic | Group A (Dian Dao San Group) | Group B( Topical Medicine Without Therapeutic Effects) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 11 Participants | 23 Participants |
| Age, Continuous | 41.08 years STANDARD_DEVIATION 14.94 | 52.08 years STANDARD_DEVIATION 10.93 | 46.58 years STANDARD_DEVIATION 12.94 |
| Race/Ethnicity, Customized | 12 Participants | 12 Participants | 24 Participants |
| Region of Enrollment Taiwan | 12 participants | 12 participants | 24 participants |
| Sex: Female, Male Female | 10 Participants | 8 Participants | 18 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
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).
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A (Dian Dao San Group) | Reduction of Flushing, Erythema, Telangiectasia, Papules, and Pustules | 1 score on a scale | Standard Deviation 0.43 |
| Group B( Topical Medicine Without Therapeutic Effects) | Reduction of Flushing, Erythema, Telangiectasia, Papules, and Pustules | 1.92 score on a scale | Standard Deviation 0.67 |
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A (Dian Dao San Group) | Dermatology Quality of Life Index, DQoL | 2.83 score on a scale | Standard Deviation 2.25 |
| Group B( Topical Medicine Without Therapeutic Effects) | Dermatology Quality of Life Index, DQoL | 6.25 score on a scale | Standard Deviation 4.49 |