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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05045469
Other study ID # 202101000A3
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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