Herbal Ointment in Treating Atopic Dermatitis Topically

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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
• Препарат 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.

Первичные конечные точки

• Percentage change in Eczema Area Severity Index (EASI) scores from baseline to week 4 [Срок оценки: 4 weeks]

Вторичные конечные точки (6)

• Proportion of subjects who have achieved EASI-50, EASI-75, and EASI-90 after 4 weeks of treatment [Срок оценки: 4 weeks]
• The mean change in Dermatology Life Quality Index (DLQI)from baseline to week 4 [Срок оценки: 4 weeks]
• Visual Analogue Scale (VAS) for pruritus severity rates [Срок оценки: 4 weeks]
• The mean percentage change in Total Body Surface Area involved with AD (BSA, range 0%-100%) from baseline to week 4 [Срок оценки: 4 weeks]
• Proportion of subjects with a change in Investigator's Global Assessment (IGA, range 0-5 from baseline to week 4. ) [Срок оценки: 4 weeks]
• TCMBCQ (Time Frame: Change from Baseline TCMBCQ at 4weeks) [Срок оценки: 4 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Тайвань · 1 центр

• En Chu Kong hospital — New Taipei City

Идентификаторы

NCT: NCT06850311 · ECKIRB1130403

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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