Therapeutic Effects of Topical Herbal Medicine on Rosacea
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Reduction of Flushing, Erythema, Telangiectasia, Papules, and Pustules
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: dian dao san (Drug)
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.
Intervention: dian dao san (Drug)
Outcomes
Primary Outcomes
Reduction of Flushing, Erythema, Telangiectasia, Papules, and Pustules
Time Frame: 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 Outcomes
- Dermatology Quality of Life Index, DQoL(6 weeks)