Clinical trial NCT06850311: Herbal Ointment in Treating Atopic Dermatitis Topically
Official title: Efficacy and Safety of Herbal Topical Ointment in Treating Atopic Dermatitis: A Randomized, Double-Blind, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Atopic Dermatitis
Atopic Dermatitis (AD)
Atopic Dermatitis (Eczema)
Atopic Dermatitis Eczema
TCM
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic
Lead sponsor: En Chu Kong Hospital
Sponsor class: OTHER
First posted: 2025-02-27
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Atopic dermatitis (AD), also known as atopic eczema, is a chronic inflammatory skin disorder. The current first-line recommended treatment for AD is the use of emollients, topical corticosteroids (TCS), and oral antihistamines if necessary. However, patients often have side effects like skin atrophy and telangiectasia. And there were plenty of herbal medicine which are beneficial to atopic dermatitis in ancient Chinese medicine books and records. Therefore, the purpose of this study is to develop a new topical application of traditional Chinese medicine and evaluate its clinical efficacy in AD patients. In human trial, 66 Subjects diagnosed as AD will be enrolled and treated with Sophora flavescens Aiton topical ointment. After treatment we will estimate the efficacy and record adverse events to conduct statistically analysis.

The 1st year project: (1) Expect to enroll 66 clinical subjects of AD. (2) Evaluate subjects 'symptom and proceed herbal ointment treatment. (3) Record treatment responses including adverse effect. (4) Conduct statistically analysis.

The 2nd year project: (1) Completing enrollment of 66 clinical subjects of AD. (2) Finish evaluation and treatment of all subjects. (3) Statistically analysis all collecting data (4) Discuss and analyze the outcome.


Eligibility criteria: Inclusion Criteria:

1. Between 18 and 65 years old, female or male.
2. Atopic dermatitis fulfilling the diagnostic criteria of Hanifin\&Rajka.
3. Atopic dermatitis involving \<10% of BSA. (Base on the BSA result of Screening)
4. An Investigator's Global Assessment (IGA) score of 2, 3 or 4 which corresponds to mild, moderate or severe disease. (Base on the IGA result of Screening)
5. Female patients of child-bearing age with negative pregnancy test at screening.
6. Female patients of child-bearing age that agree to continue using birth control measures approved by the investigator and agree not to lactate for the duration of the study.

Agree to only receive stable doses of an additive-free, basic bland emollient for at least 7 days before baseline (day0) Willing to comply with study protocol and agree to sign an informed consent form.

Exclusion Criteria:

1. Having a history of topical or systematical hypersensitivity to herbal or its excipient (e.g. vehicle) in ointment
2. Undergoing phototherapy (e.g. UVB, PUVA) or systemic therapy (e.g. Immunosuppressive agents) within 30 days.
3. Having used topical or oral therapy (e.g. topical corticosteroids, antibiotic, TCM) for dermatitis within 7 days before the first application of the study medication.
4. Having a significant concurrent disease, such as: significant abnormalities in hematology, severe uncontrolled metabolic syndrome (e.g., hypertension, diabetes mellitus, metabolic arthritis, hyperthyroidism), psychiatric disease, cancer or AIDS.
5. Having abnormal liver or renal function (AST/ALT \>3 x ULN, creatinine \>2.0 mg/dl).
6. Women who are lactating, pregnant or preparing to be pregnant.

Primary outcomes:
measure: Percentage change in Eczema Area Severity Index (EASI) scores from baseline to week 4
timeFrame: 4 weeks
Secondary outcomes:
measure: Proportion of subjects who have achieved EASI-50, EASI-75, and EASI-90 after 4 weeks of treatment
timeFrame: 4 weeks
measure: The mean change in Dermatology Life Quality Index (DLQI)from baseline to week 4
timeFrame: 4 weeks
measure: Visual Analogue Scale (VAS) for pruritus severity rates
timeFrame: 4 weeks
measure: The mean percentage change in Total Body Surface Area involved with AD (BSA, range 0%-100%) from baseline to week 4
timeFrame: 4 weeks
measure: Proportion of subjects with a change in Investigator's Global Assessment (IGA, range 0-5 from baseline to week 4. )
timeFrame: 4 weeks
measure: TCMBCQ (Time Frame: Change from Baseline TCMBCQ at 4weeks)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: En Chu Kong hospital
Study officials:
References: