Herbal Ointment in Treating Atopic Dermatitis Topically

Efficacy and Safety of Herbal Topical Ointment in Treating Atopic Dermatitis: A Randomized, Double-Blind, Placebo-Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Atopic Dermatitis; Atopic Dermatitis (Eczema); Atopic Dermatitis Eczema; Atopic Dermatitis (AD); TCM
• Intervention / Treatment: Drug: herbal ointment; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Ms. Chen; Phone Number: 886+(02)+27623456 #3118; Email: 11759@km.eck.org.tw

Study Locations

• Taiwan
  • New Taipei City, Taiwan, 237
    • Recruiting
    • En Chu Kong Hospital
    • Contact: Ms. Chen; Phone Number: 3118 886-02-26723456; Email: 11759@km.eck.org.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: herbal ointment; Form: ointment; Dose: each gram of ointment contains TCM; Dosing schedule: apply 0.5g of ointment per 10 x 10 dermatitis lesion twice daily	Drug: herbal ointment; Every 10 x 10 cm area of lesion requires 0.5 g of ointment, applied twice daily (morning and evening, separated by approximately 12±2 hours) for 4 weeks; Drug: Placebo; Every 10 x 10 cm area of lesion requires 0.5 g of ointment, applied twice daily (morning and evening, separated by approximately 12±2 hours) for 4 weeks.
Placebo Comparator: placebo ointment; Form: ointment; Dose: vehicle; Dosing schedule: apply 0.5g of ointment per 10 x 10 dermatitis lesion twice daily	Drug: herbal ointment; Every 10 x 10 cm area of lesion requires 0.5 g of ointment, applied twice daily (morning and evening, separated by approximately 12±2 hours) for 4 weeks; Drug: Placebo; Every 10 x 10 cm area of lesion requires 0.5 g of ointment, applied twice daily (morning and evening, separated by approximately 12±2 hours) for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage change in Eczema Area Severity Index (EASI) scores from baseline to week 4	The Eczema Area and Severity Index (EASI) is used to measure the disease severity of erythema, infiltration/papulation, excoriation, and lichenification each on a scale of 0 to 3 (none to severe) as well as the percentage of disease area on a scale of 0 to 6 for the head ⁄ neck, upper limb, trunk and lower limb body regions. Each body region score is calculated by multiplying the disease severity score by the disease area score and by the multiplier. The scores are summed to give the total EASI score, ranging from 0 to a maximum 72. The mean percentage change in EASI = (EASI baseline-EASI post-treat) / EASI baseline x 100%	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects who have achieved EASI-50, EASI-75, and EASI-90 after 4 weeks of treatment	It is defined as at least 50%, 75%, and 90% reduction in EASI score relative to the baseline.	4 weeks
The mean change in Dermatology Life Quality Index (DLQI)from baseline to week 4	The DLQI is a self-administered 10-item questionnaire, ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired.	4 weeks
Visual Analogue Scale (VAS) for pruritus severity rates	from 0 (no itching) to 10 (very severe itching)	4 weeks
The mean percentage change in Total Body Surface Area involved with AD (BSA, range 0%-100%) from baseline to week 4	BSA is total Body Surface Area involved, ranging from 0% (none) to 100% (total body surface involved)	4 weeks
Proportion of subjects with a change in Investigator's Global Assessment (IGA, range 0-5 from baseline to week 4. )	Proportion of subjects with an IGA score of 0 (clear) or 1 (almost clear) at week 6.; Proportion of subjects with ≥ 2 point improvement in IGA at week 4.	4 weeks
TCMBCQ (Time Frame: Change from Baseline TCMBCQ at 4weeks)	Traditional Chinese Medicine Body Constitution Questionnaire	4 weeks

Collaborators and Investigators

• Sponsor: En Chu Kong Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: February 23, 2025
• First Submitted That Met QC Criteria: February 23, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 23, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Genetic Diseases, Inborn; Dermatitis, Atopic; Dermatitis; Eczema; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous
• Other Study ID Numbers: ECKIRB1130403

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: primary and secondary outcome of this study
• IPD Sharing Time Frame: information sharing after paper published
• IPD Sharing Access Criteria: all in public, without any kind of review
• IPD Sharing Supporting Information Type: ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No