A Phase 2/3 interventional study of herbal ointment and Placebo in Atopic Dermatitis, Atopic Dermatitis (AD) and Atopic Dermatitis (Eczema), sponsored by En Chu Kong Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-02-27.
Sponsored by En Chu Kong Hospital · Phase 2/3, Interventional, and Treatment
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.
1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.
This study's planned enrollment of 66 is below the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →En Chu Kong Hospital is the lead sponsor of 10 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 form.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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.
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%
Time frame: 4 weeks
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.
Time frame: 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.
Time frame: 4 weeks
Visual Analogue Scale (VAS) for pruritus severity rates
from 0 (no itching) to 10 (very severe itching)
Time frame: 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)
Time frame: 4 weeks
Proportion of subjects with a change in Investigator's Global Assessment (IGA, range 0-5 from baseline to week 4. )
1. Proportion of subjects with an IGA score of 0 (clear) or 1 (almost clear) at week 6. 2. Proportion of subjects with ≥ 2 point improvement in IGA at week 4.
Time frame: 4 weeks
TCMBCQ (Time Frame: Change from Baseline TCMBCQ at 4weeks)
Traditional Chinese Medicine Body Constitution Questionnaire
Time frame: 4 weeks
Plan to share: Yes — primary and secondary outcome of this study
Supporting information: Informed consent form, Clinical study report
Time frame: information sharing after paper published
Access criteria: all in public, without any kind of review
No publications or documents are linked to this record.
Start is estimated for Mar 2025; primary completion for Mar 2027, 24 months later.
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En Chu Kong Hospital