Herbal Ointment in Treating Atopic Dermatitis Topically

NCT06850311 | Recruiting Phase 2

• 1 other identifier: ECKIRB1130403
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis; Atopic Dermatitis (AD); Atopic Dermatitis Eczema; TCM; Skin Diseases; Skin Diseases, Eczematous; Skin Diseases, Genetic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Proportion of subjects who have achieved EASI-50, EASI-75, and EASI-90 after 4 weeks of treatment

  4 weeks

• The mean change in Dermatology Life Quality Index (DLQI)from baseline to week 4

  4 weeks

• Visual Analogue Scale (VAS) for pruritus severity rates

  4 weeks

• The mean percentage change in Total Body Surface Area involved with AD (BSA, range 0%-100%) from baseline to week 4

  4 weeks

• Proportion of subjects with a change in Investigator's Global Assessment (IGA, range 0-5 from baseline to week 4. )

  4 weeks

Study Arms (2)

herbal ointment

EXPERIMENTAL

1. Form: ointment 2. Dose: each gram of ointment contains TCM 3. Dosing schedule: apply 0.5g of ointment per 10 x 10 dermatitis lesion twice daily

Drug: herbal ointment; Drug: Placebo

placebo ointment

PLACEBO COMPARATOR

1. Form: ointment 2. Dose: vehicle 3. Dosing schedule: apply 0.5g of ointment per 10 x 10 dermatitis lesion twice daily

Drug: herbal ointment; Drug: Placebo

Interventions

herbal ointment DRUG

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

herbal ointment; placebo ointment

Placebo DRUG

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.

herbal ointment; placebo ointment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between 18 and 65 years old, female or male.
• Atopic dermatitis fulfilling the diagnostic criteria of Hanifin\&Rajka.
• Atopic dermatitis involving \<10% of BSA. (Base on the BSA result of Screening)
• 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)
• Female patients of child-bearing age with negative pregnancy test at screening.
• 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.

You may not qualify if:

• Having a history of topical or systematical hypersensitivity to herbal or its excipient (e.g. vehicle) in ointment
• Undergoing phototherapy (e.g. UVB, PUVA) or systemic therapy (e.g. Immunosuppressive agents) within 30 days.
• 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.
• 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.
• Having abnormal liver or renal function (AST/ALT \>3 x ULN, creatinine \>2.0 mg/dl).
• Women who are lactating, pregnant or preparing to be pregnant.

Sponsors & Collaborators

• En Chu Kong Hospital: lead

Study Sites (1)

En Chu Kong hospital

New Taipei City, 237, Taiwan

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema; Skin Diseases; Skin Diseases, Eczematous; Skin Diseases, Genetic

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Ms. Chen

CONTACT

886+(02)+27623456 #3118; 11759@km.eck.org.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: attending physician of department of Traditional Chinese medicine

Study Record Dates

• First Submitted: February 23, 2025
• First Posted: February 27, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF, CSR
• Time Frame: information sharing after paper published
• Access Criteria: all in public, without any kind of review

Locations

TW (1)