Atopic DermatitisPhase 1/2NCT05613062
Modified Huang-Lian-Jie-Du Decoction (MHLJDD) for Atopic Dermatitis in Children
A Phase 1/2 study testing Modified Huang-Lian-Jie-Du Decoction (MHLJDD) in people with Atopic Dermatitis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
The study aims to evaluate the clinical efficacy of Chinese medicine (CM) for the treatment of subacute and chronic Atopic Dermatitis (AD) patients when compared to the placebo control by examining the clinical symptoms. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Modified Huang-Lian-Jie-Du Decoction (MHLJDD)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteHong Kong
- Study dates
- 11 Apr 2023to 27 Aug 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age of 4 to 17 (Chinese only);
- With EASI ≥ 10;
- Subacute and chronic atopic dermatitis presenting with dry, scaly, erythematous papules and plaques; and
- Provide a written informed consent form (signed by one of their parents)
Who cannot join
- History of allergy to Chinese medicines;
- AD with Yang deficiency in syndrome differentiation, such as pale looking, always feeling cold, fatigue, chronic diarrhea with loose stool, urinary disorders such as urinary difficulty, excessive urination or incontinence
- Known overt bacterial infections in the skin;
- Known pregnancy;
- Known severe medical conditions, such as cardiovascular, liver or renal dysfunction or Diabetes Mellitus;
- Having used oral corticosteroids, oral antibiotics, other immunosuppressive or any preparation of oral herbal medicines for the treatment of AD in the past month;
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- Having been diagnosed with scabies, allergic contact dermatitis, seborrheic dermatitis or psoriasis;
- Has taken anti-coagulant or anti-platelet drugs in the past month;
- Has taken any probiotics, prebiotics in the last month; and
- Known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Placebo-Controlled Pilot Study of an Herbal Formula Modified Huang-Lian-Jie-Du Decoction (MHLJDD) for Atopic Dermatitis in Children
The study aims to evaluate the clinical efficacy of Chinese medicine (CM) for the treatment of subacute and chronic Atopic Dermatitis (AD) patients when compared to the placebo control by examining the clinical symptoms.
Read the detailed description
This is a parallel, randomized, placebo-controlled, double-blind pilot study. The subjects will come for a screening visit at week 0 (baseline), then at week 6±3 days, week 12±3 days and week 16±4 days for Chinese medicine practitioner (CMP) investigators' assessments (Fig 1). Eczema Area and Severity Index (EASI), Children's dermatology life quality index (CDLQI), and Patient-Oriented Eczema Measure (POEM) will be assessed and filled up at different time points. Eligible subjects will be randomly allocated to the treatment group receiving oral CM granules or the placebo control group receiving oral placebo granules for 12 weeks, and then be followed up 4 weeks after the treatment.
- Conditions
- Atopic Dermatitis
- Being tested
- Modified Huang-Lian-Jie-Du Decoction (MHLJDD), Placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Huang-Lian-Jie-Du Decoction (MHLJDD)Drug
Also called Chinese medicine
Chinese medicine granules for 12 weeks twice daily
PlaceboDrug
Placebo granules for 12 weeks twice daily
| Study group | Role | What they receive |
|---|---|---|
| Active treatment (Modified Huang-Lian-Jie-Du Decoction (MHLJDD)) | Experimental | Chinese medicine Receives: Drug: Modified Huang-Lian-Jie-Du Decoction (MHLJDD) |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
EASI score
The change of EASI score for atopic dermatitis at week 12 Min value: 0, max value: 72, higher scores mean worse outcome. To assess the severity of atopic dermatitis.
Measured: 12 weeks
Secondary outcomes (16)
EASI score
The change of EASI score for atopic dermatitis at week 6 Min value: 0, max value: 72, higher scores mean worse outcome. To assess the severity of atopic dermatitis
Measured: 6 weeks
EASI score
The change of EASI score for atopic dermatitis at week16 Min value: 0, max value: 72, higher scores mean worse outcome. To assess the severity of atopic dermatitis
Measured: 16 weeks
CDLQI score
The change of CDLQI score at week 12 Min value: 0, max value: 30, higher scores mean worse outcome. To assess the quality of life of subjects.
Measured: 12 weeks
CDLQI score
The change of CDLQI score at week 16 Min value: 0, max value: 30, higher scores mean worse outcome. To assess the quality of life of subjects.
Measured: 16 weeks
POEM score
The change of POEM score at week 12 Min value: 0, max value: 28, higher scores mean worse outcome. To assess the subjective symptoms of subjects.
Measured: 12 weeks
POEM score
The change of POEM score at week 16 Min value: 0, max value: 28, higher scores mean worse outcome. To assess the subjective symptoms of subjects.
Measured: 16 weeks
Microbiome
The change of microbiome at week 12. The oral and gut microbiota are the collection of microbial agents such as bacteria, viruses and fungi that inhabit in the mouth cavity and gut. Bacterial microbiome sequencing is performed using 16S ribosomal RNA pyrosequencing.
Measured: 12 weeks
Time of flare
The time to reach flare (defined as major exacerbation disease increase > 50% of baseline EASI)
Measured: 16 weeks
The number of subjects reaches flare
The number of subjects reaches flare (defined as major exacerbation disease increase > 50% of baseline EASI)
Measured: 16 weeks
Trans-epidermal water loss (TEWL)
Trans-epidermal water loss (TEWL) at week 6 The Trans-epidermal water loss (TWEL) is measured in g/m2h, which range from 0 to 300. An increasing TEWL value indicates greater skin dryness.
Measured: 6 weeks
Trans-epidermal water loss (TEWL)
Trans-epidermal water loss (TEWL) at week 12 The Trans-epidermal water loss (TWEL) is measured in g/m2h, which range from 0 to 300. An increasing TEWL value indicates greater skin dryness.
Measured: 12 weeks
Trans-epidermal water loss (TEWL)
The change of trans-epidermal water loss (TEWL) at week 16 The TWEL is measured in g/m2h, which range from 0 to 300. An increasing TEWL value indicates greater skin dryness.
Measured: 16 weeks
Skin hydration (SH)
The change of skin hydration (SH) at week 6 The SH is measured in arbitrary units (a.u.), which range from 0 to 300 a.u.
Measured: 6 weeks
Skin hydration (SH)
The change of skin hydration (SH) at week 12 The SH is measured in arbitrary units (a.u.), which range from 0 to 300 a.u.
Measured: 12 weeks
Skin hydration (SH)
The change of skin hydration (SH) at week 16 Skin hydration will be measured topically using the measuring device at a standard site below the antecubital fossa of each patient's right arm. The SH is measured in arbitrary units (a.u.), which range from 0 to 300 a.u.
Measured: 16 weeks
Adverse event
Adverse event will be assessed in the study period
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start11 Apr 2023
- Primary completion27 Aug 2024
- Study completion27 Aug 2024
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.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Lin Zhixiu, Chinese University of Hong Kong
- Investigators
- Zhixiu Lin, Principal investigator, Integrative Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05613062
- Sponsor's protocol ID
- AD HLJDD study
- Status last verified
- Jul 2026
- First submitted
- 29 Sep 2022
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Placebo-Controlled Pilot Study of an Herbal Formula Modified Huang-Lian-Jie-Du Decoction (MHLJDD) for Atopic Dermatitis in Children
- ClinicalTrials.gov ID
- NCT05613062
- Acronym / sponsor ID
- AD HLJDD study
- Conditions
- Atopic Dermatitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 11 Apr 2023 (actual)
- Primary completion
- 27 Aug 2024 (actual)
- Study completion
- 27 Aug 2024 (actual)
- First posted
- 14 Nov 2022 (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.
The study aims to evaluate the clinical efficacy of Chinese medicine (CM) for the treatment of subacute and chronic Atopic Dermatitis (AD) patients when compared to the placebo control by examining the clinical symptoms.
Detailed description
This is a parallel, randomized, placebo-controlled, double-blind pilot study. The subjects will come for a screening visit at week 0 (baseline), then at week 6±3 days, week 12±3 days and week 16±4 days for Chinese medicine practitioner (CMP) investigators' assessments (Fig 1). Eczema Area and Severity Index (EASI), Children's dermatology life quality index (CDLQI), and Patient-Oriented Eczema Measure (POEM) will be assessed and filled up at different time points. Eligible subjects will be randomly allocated to the treatment group receiving oral CM granules or the placebo control group receiving oral placebo granules for 12 weeks, and then be followed up 4 weeks after the treatment.
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 |
|---|---|---|
| Active treatment (Modified Huang-Lian-Jie-Du Decoction (MHLJDD)) | Experimental | Drug: Modified Huang-Lian-Jie-Du Decoction (MHLJDD)Chinese medicine |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age of 4 to 17 (Chinese only);
- With EASI ≥ 10;
- Subacute and chronic atopic dermatitis presenting with dry, scaly, erythematous papules and plaques; and
- Provide a written informed consent form (signed by one of their parents)
Key exclusion criteria (10 listed)
- History of allergy to Chinese medicines;
- AD with Yang deficiency in syndrome differentiation, such as pale looking, always feeling cold, fatigue, chronic diarrhea with loose stool, urinary disorders such as urinary difficulty, excessive urination or incontinence
- Known overt bacterial infections in the skin;
- Known pregnancy;
- Known severe medical conditions, such as cardiovascular, liver or renal dysfunction or Diabetes Mellitus;
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 |
|---|---|---|
| Modified Huang-Lian-Jie-Du Decoction (MHLJDD)Also: Chinese medicineChinese medicine granules for 12 weeks twice daily | Drug | Active treatment (Modified Huang-Lian-Jie-Du Decoction (MHLJDD)) |
| PlaceboPlacebo granules for 12 weeks twice daily | Drug | Placebo |
Primary outcome
EASI score
Time frame: 12 weeks
The change of EASI score for atopic dermatitis at week 12 Min value: 0, max value: 72, higher scores mean worse outcome. To assess the severity of atopic dermatitis.
16 secondary outcomes
EASI score
Time frame: 6 weeks
EASI score
Time frame: 16 weeks
CDLQI score
Time frame: 12 weeks
CDLQI score
Time frame: 16 weeks
POEM score
Time frame: 12 weeks
POEM score
Time frame: 16 weeks
Microbiome
Time frame: 12 weeks
Time of flare
Time frame: 16 weeks
The number of subjects reaches flare
Time frame: 16 weeks
Trans-epidermal water loss (TEWL)
Time frame: 6 weeks
Trans-epidermal water loss (TEWL)
Time frame: 12 weeks
Trans-epidermal water loss (TEWL)
Time frame: 16 weeks
Skin hydration (SH)
Time frame: 6 weeks
Skin hydration (SH)
Time frame: 12 weeks
Skin hydration (SH)
Time frame: 16 weeks
Adverse event
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Zhixiu Lin principal investigator
Integrative Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Modified Huang-Lian-Jie-Du Decoction (MHLJDD) in people with Atopic Dermatitis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 4 inclusion and 10 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: finished, as of the sponsor's last update on 27 Jul 2026. 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 Hong Kong. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EASI score (time frame: 12 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 Jul 2026.