Therapeutic Effects of Topical Herbal Medicine -Rhubarb Ointment on Rosacea

Phase 2

Completed

• Conditions: Chinese Herbal Medicine; Rosacea
• Interventions: Drug: dian dao san

• Registration Number: NCT05045469
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Study Timeline

• Study Start: 2021-08-04
• Study First Submitted: 2021-09-07
• Study First Submitted QC: 2021-09-07
• Study First Posted: 2021-09-16
• Status Verified: 2024-01
• Primary Completion: 2024-05-23
• Study Completion: 2024-08-04
• Results First Submitted: 2025-02-16
• Results First Submitted QC: 2025-03-13
• Last Update Submitted: 2025-03-13
• Results First Posted: 2025-04-01
• Last Update Posted: 2025-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group B( topical medicine without therapeutic effects)	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.
group A (dian dao san group)	dian dao san	Herbal medicine (dian dao san) will be applied to the lesions of rosacea twice a day. Subject will receive persistent treatment for 6 weeks.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Keelung Chang Gung Memorial Hospital; 🇨🇳 Keelung, Taiwan