Therapeutic Effects of Topical Herbal Medicine -Rhubarb Ointment on Rosacea

Rosacea Clinical Trial

Official title:

Therapeutic Effects of Topical Herbal Medicine on Rosacea

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05045469
• Other study ID #: 202101000A3
• Status: Recruiting
• Phase: Phase 2
• Start date: August 4, 2021
• Est. completion date: August 4, 2023

Study information

• Verified date: September 2021
• Source: Chang Gung Memorial Hospital
• Contact: YUAN-CHIEH YEH, Doctor
• Phone: 24313131
• Email: b9005030[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: August 4, 2023
• Est. primary completion date: August 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chinese Herbal Medicine
• Rosacea

Intervention

Drug:
• dian dao san
dian dao san and placebo will be used in the rosacea lesions twice a day for 6 weeks

Locations

Country	Name	City	State
Taiwan	Keelung Chang Gung Memorial Hospital	Keelung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	6 weeks
Primary	absence of adverse skin reaction to topical medicine	scored with Dyshidrotic Eczema Area and Severity Index (DASI index). The total score of the DASI results from the sum of severity grade score points of each of the four items (V = vesicles, E = erythema, S = desquamation, I = itch) multiplied by the affected area (A) score points: DASI = (pV + pE + pS + pI) × pA.; The maximum possible score is 60. By the DASI, the dyshidrotic eczema is graded as: mild (0-15), moderate (16-30) and severe (31-60).	6 weeks
Secondary	improvement of life quality	Dermatology Quality of Life Index, DQoL is the questionnaire which designed to measure the health-related quality of life of adult patients suffering from a skin disease ranging from 0(no effect at all on patient's life) to 30(extremely large effect on patient's life).	6 weeks