Atopic DermatitisPhase 2/3NCT06850311
Herbal Ointment in Treating Atopic Dermatitis Topically
A Phase 2/3 study testing herbal ointment in people with Atopic Dermatitis and Atopic Dermatitis (AD), run by En Chu Kong Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Atopic Dermatitis, Atopic Dermatitis (AD), Atopic Dermatitis (Eczema)
- What is being tested?
- herbal ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2025to 1 Apr 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
En Chu Kong hospital
New Taipei City, 237
Ms. Chen, 886-02-26723456 ext. 3118, 11759@km.eck.org.tw
About this study
Official title: 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.
- Conditions
- Atopic Dermatitis, Atopic Dermatitis (AD), Atopic Dermatitis (Eczema), Atopic Dermatitis Eczema, TCM, Skin Diseases
- Being tested
- herbal ointment, Placebo
- Medical subject headings
- Dermatitis, Atopic, Eczema, Skin Diseases, Skin Diseases, Eczematous, Skin Diseases, Genetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
herbal ointmentDrug
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
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: herbal ointment; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: 4 weeks
Secondary outcomes (6)
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.
Measured: 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.
Measured: 4 weeks
Visual Analogue Scale (VAS) for pruritus severity rates
from 0 (no itching) to 10 (very severe itching)
Measured: 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)
Measured: 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.
Measured: 4 weeks
TCMBCQ (Time Frame: Change from Baseline TCMBCQ at 4weeks)
Traditional Chinese Medicine Body Constitution Questionnaire
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- En Chu Kong Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chi-Wen Huang, MD, En Chu Kong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06850311
- Sponsor's protocol ID
- ECKIRB1130403
- Status last verified
- Feb 2025
- First submitted
- 23 Feb 2025
- Last updated
- 27 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: primary and secondary outcome of this study
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Herbal Topical Ointment in Treating Atopic Dermatitis: A Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT06850311
- Acronym / sponsor ID
- ECKIRB1130403
- Conditions
- Atopic Dermatitis, Atopic Dermatitis (AD), Atopic Dermatitis (Eczema), Atopic Dermatitis Eczema, TCM, Skin Diseases
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- En Chu Kong HospitalUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 27 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| herbal ointment | Experimental | Drug: herbal ointment, Drug: Placebo1. 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 |
| placebo ointment | Placebo comparator | Drug: herbal ointment, Drug: Placebo1. Form: ointment 2. Dose: vehicle 3. Dosing schedule: apply 0.5g of ointment per 10 x 10 dermatitis lesion twice daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| herbal ointmentEvery 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 | herbal ointment, placebo ointment |
| PlaceboEvery 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 | herbal ointment, placebo ointment |
Primary outcome
Percentage change in Eczema Area Severity Index (EASI) scores from baseline to week 4
Time frame: 4 weeks
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%
6 secondary outcomes
Proportion of subjects who have achieved EASI-50, EASI-75, and EASI-90 after 4 weeks of treatment
Time frame: 4 weeks
The mean change in Dermatology Life Quality Index (DLQI)from baseline to week 4
Time frame: 4 weeks
Visual Analogue Scale (VAS) for pruritus severity rates
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
Time frame: 4 weeks
Proportion of subjects with a change in Investigator's Global Assessment (IGA, range 0-5 from baseline to week 4. )
Time frame: 4 weeks
TCMBCQ (Time Frame: Change from Baseline TCMBCQ at 4weeks)
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. primary and secondary outcome of this study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing herbal ointment in people with Atopic Dermatitis and Atopic Dermatitis (AD), run by En Chu Kong Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ms. Chen (886+(02)+27623456 #3118, 11759@km.eck.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in Eczema Area Severity Index (EASI) scores from baseline to week 4 (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.