Actively Recruiting
Efficacy and Safety of Herbal Topical Ointment in Treating Atopic Dermatitis: A Randomized, Double-Blind, Placebo-Controlled Trial
Led by En Chu Kong Hospital · Updated on 2025-02-27
66
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new topical herbal ointment derived from traditional Chinese medicine for treating atopic dermatitis (AD), a chronic inflammatory skin condition also known as eczema. The study aims to compare this herbal ointment's clinical effects with a placebo ointment in patients with AD, addressing common side effects seen with current treatments like corticosteroids. This randomized, double-blind, placebo-controlled trial is sponsored by En Chu Kong Hospital and will enroll 66 subjects aged 18 to 65 diagnosed with AD. Participants will be randomly assigned to receive either the herbal ointment or a placebo ointment. Both ointments are applied twice daily at a dose of 0.5 grams per 10 x 10 cm area of skin affected by dermatitis for 4 weeks. The ointments are delivered topically to the affected skin lesions. The study includes two project years: the first focuses on enrolling subjects and beginning treatment, while the second year completes treatment, collects data, and performs statistical analysis. During the study, participants will be assessed for changes in eczema severity using the Eczema Area Severity Index (EASI) over 4 weeks, along with other measures such as quality of life, itch severity, body surface area affected, and global assessment scores. Researchers will monitor treatment responses and record any adverse events. The total participation time includes a 4-week treatment phase with evaluations before and after treatment to assess safety and efficacy.
CONDITIONS
Brief Title
Herbal Ointment in Treating Atopic Dermatitis Topically
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between 18 and 65 years old, female or male
- Diagnosed with atopic dermatitis fulfilling the Hanifin & Rajka criteria
- Atopic dermatitis involving less than 10% of body surface area
- Investigator's Global Assessment (IGA) score of 2, 3, or 4 (mild to severe disease)
- Female patients of child-bearing age with a negative pregnancy test at screening
- Female patients of child-bearing age agree to use approved birth control and not to lactate during the study
- Willing to use stable doses of an additive-free, basic bland emollient for at least 7 days before baseline
- Agree to comply with the study protocol and sign informed consent
You will not qualify if you...
- History of hypersensitivity to herbal ointment or its components
- Undergoing phototherapy or systemic therapy within 30 days before the study
- Use of topical or oral therapy for dermatitis within 7 days before starting the study medication
- Having significant concurrent diseases such as serious blood abnormalities, uncontrolled metabolic conditions, psychiatric disease, cancer, or AIDS
- Abnormal liver or kidney function (AST/ALT >3 times normal, creatinine >2.0 mg/dl)
- Women who are pregnant, lactating, or planning to become pregnant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 4 weeks
Participants apply 0.5 g of herbal or placebo ointment per 10 x 10 cm lesion twice daily for 4 weeks.
Twice daily application for 4 weeks
Trial Site Locations
Total: 1 location
1
En Chu Kong hospital
New Taipei City, Taiwan, 237
Actively Recruiting
Research Team
M
Ms. Chen
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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