Therapeutic Effects of Topical Herbal Medicine -Rhubarb Ointment on Rosacea

Therapeutic Effects of Topical Herbal Medicine on Rosacea

The aim of this study is to investigate the effects of topical herbal medicine in the patients with rosacea.

Study Overview

• Status: Completed
• Conditions: Rosacea; Chinese Herbal Medicine
• Intervention / Treatment: Drug: dian dao san

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 2

Contacts and Locations

Study Locations

• Taiwan
  • Keelung, Taiwan
    • Keelung Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: dian dao san; dian dao san and placebo will be used in the rosacea lesions twice a day for 6 weeks
Placebo Comparator: 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.	Drug: dian dao san; dian dao san and placebo will be used in the rosacea lesions twice a day for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	6 weeks

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: YUAN-CHIEH YEH, Doctor, Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2021
• Primary Completion (Actual): May 23, 2024
• Study Completion (Actual): August 4, 2024

Study Registration Dates

• First Submitted: September 7, 2021
• First Submitted That Met QC Criteria: September 7, 2021
• First Posted (Actual): September 16, 2021

Study Record Updates

• Last Update Posted (Actual): April 1, 2025
• Last Update Submitted That Met QC Criteria: March 13, 2025
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Rosacea
• Other Study ID Numbers: 202101000A3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No