A Phase 2 interventional study of dian dao san in Rosacea and Chinese Herbal Medicine, sponsored by Chang Gung Memorial Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2025-04-01.
Sponsored by Chang Gung Memorial Hospital · Phase 2, Interventional, and Treatment
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.
Exclusion Criteria:
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
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
dian dao san and placebo will be used in the rosacea lesions twice a day for 6 weeks
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
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
| Milestone | Group A (Dian Dao San Group) | Group B( Topical Medicine Without Therapeutic Effects) |
|---|---|---|
| Started | 12 | 12 |
| Completed | 12 | 12 |
| Not completed | 0 | 0 |
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).
| score on a scale | Group A (Dian Dao San Group) | Group B( Topical Medicine Without Therapeutic Effects) |
|---|---|---|
| Reduction of Flushing, Erythema, Telangiectasia, Papules, and Pustules | 1 ± 0.43 | 1.92 ± 0.67 |
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.
| score on a scale | Group A (Dian Dao San Group) | Group B( Topical Medicine Without Therapeutic Effects) |
|---|---|---|
| Dermatology Quality of Life Index, DQoL | 2.83 ± 2.25 | 6.25 ± 4.49 |
Collected over 6 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group A (Dian Dao San Group) | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Group B( Topical Medicine Without Therapeutic Effects) | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Age, Categorical(Participants) | Group A (Dian Dao San Group) | Group B( Topical Medicine Without Therapeutic Effects) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 12 | 11 | 23 |
| >=65 years | 0 | 1 | 1 |
| Age, Continuous(years) | Group A (Dian Dao San Group) | Group B( Topical Medicine Without Therapeutic Effects) | Total |
|---|---|---|---|
| Mean | 41.08 ± 14.94 | 52.08 ± 10.93 | 46.58 ± 12.94 |
| Sex: Female, Male(Participants) | Group A (Dian Dao San Group) | Group B( Topical Medicine Without Therapeutic Effects) | Total |
|---|---|---|---|
| Female | 10 | 8 | 18 |
| Male | 2 | 4 | 6 |
| Race/Ethnicity, Customized(Participants) | Group A (Dian Dao San Group) | Group B( Topical Medicine Without Therapeutic Effects) | Total |
|---|---|---|---|
| Count of participants | 12 | 12 | 24 |
| Region of Enrollment(participants) | Group A (Dian Dao San Group) | Group B( Topical Medicine Without Therapeutic Effects) | Total |
|---|---|---|---|
| Taiwan | 12 | 12 | 24 |
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Chang Gung Memorial Hospital