Trial Outcomes & Findings for Therapeutic Effects of Topical Herbal Medicine -Rhubarb Ointment on Rosacea (NCT NCT05045469)
NCT ID: NCT05045469
Last Updated: 2025-04-01
Results Overview
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).
COMPLETED
PHASE2
24 participants
6 weeks
2025-04-01
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Therapeutic Effects of Topical Herbal Medicine -Rhubarb Ointment on Rosacea
Baseline characteristics by cohort
| Measure |
Group A (Dian Dao San Group)
n=12 Participants
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
|
Group B( Topical Medicine Without Therapeutic Effects)
n=12 Participants
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
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
41.08 years
STANDARD_DEVIATION 14.94 • n=5 Participants
|
52.08 years
STANDARD_DEVIATION 10.93 • n=7 Participants
|
46.58 years
STANDARD_DEVIATION 12.94 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksquantified 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).
Outcome measures
| Measure |
Group A (Dian Dao San Group)
n=12 Participants
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
|
Group B( Topical Medicine Without Therapeutic Effects)
n=12 Participants
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
|
|---|---|---|
|
Reduction of Flushing, Erythema, Telangiectasia, Papules, and Pustules
|
1 score on a scale
Standard Deviation 0.43
|
1.92 score on a scale
Standard Deviation 0.67
|
SECONDARY outcome
Timeframe: 6 weeksDQoL 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.
Outcome measures
| Measure |
Group A (Dian Dao San Group)
n=12 Participants
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
|
Group B( Topical Medicine Without Therapeutic Effects)
n=12 Participants
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
|
|---|---|---|
|
Dermatology Quality of Life Index, DQoL
|
2.83 score on a scale
Standard Deviation 2.25
|
6.25 score on a scale
Standard Deviation 4.49
|
Adverse Events
Group A (Dian Dao San Group)
Group B( Topical Medicine Without Therapeutic Effects)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place