Back to resultsModified Huang-Lian-Jie-Du Decoction (MHLJDD) for Atopic Dermatitis in Children
Primary Purpose
Atopic Dermatitis
Status
Recruiting
Phase
Phase 1
Locations
Hong Kong
Study Type
Interventional
Intervention
Modified Huang-Lian-Jie-Du Decoction (MHLJDD)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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; 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.
Sites / Locations
- School of Chinese MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Active treatment (Modified Huang-Lian-Jie-Du Decoction (MHLJDD))
Placebo
Arm Description
Chinese medicine
Placebo
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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
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.
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.
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.
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.
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.
Time of flare
The time to reach flare (defined as major exacerbation disease increase > 50% of baseline EASI)
The number of subjects reaches flare
The number of subjects reaches flare (defined as major exacerbation disease increase > 50% of baseline EASI)
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.
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.
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.
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.
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.
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.
Adverse event
Adverse event will be assessed in the study period
Full Information
NCT ID
NCT05613062
First Posted
September 29, 2022
Last Updated
July 6, 2023
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT05613062
Brief Title
Modified Huang-Lian-Jie-Du Decoction (MHLJDD) for Atopic Dermatitis in Children
Official Title
A Randomized Placebo-Controlled Pilot Study of an Herbal Formula Modified Huang-Lian-Jie-Du Decoction (MHLJDD) for Atopic Dermatitis in Children
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 11, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active treatment (Modified Huang-Lian-Jie-Du Decoction (MHLJDD))
Arm Type
Experimental
Arm Description
Chinese medicine
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Modified Huang-Lian-Jie-Du Decoction (MHLJDD)
Other Intervention Name(s)
Chinese medicine
Intervention Description
Chinese medicine granules for 12 weeks twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo granules for 12 weeks twice daily
Primary Outcome Measure Information:
Title
EASI score
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
EASI score
Description
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
Time Frame
6 weeks
Title
EASI score
Description
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
Time Frame
16 weeks
Title
CDLQI score
Description
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.
Time Frame
12 weeks
Title
CDLQI score
Description
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.
Time Frame
16 weeks
Title
POEM score
Description
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.
Time Frame
12 weeks
Title
POEM score
Description
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.
Time Frame
16 weeks
Title
Microbiome
Description
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.
Time Frame
12 weeks
Title
Time of flare
Description
The time to reach flare (defined as major exacerbation disease increase > 50% of baseline EASI)
Time Frame
16 weeks
Title
The number of subjects reaches flare
Description
The number of subjects reaches flare (defined as major exacerbation disease increase > 50% of baseline EASI)
Time Frame
16 weeks
Title
Trans-epidermal water loss (TEWL)
Description
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.
Time Frame
6 weeks
Title
Trans-epidermal water loss (TEWL)
Description
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.
Time Frame
12 weeks
Title
Trans-epidermal water loss (TEWL)
Description
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.
Time Frame
16 weeks
Title
Skin hydration (SH)
Description
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.
Time Frame
6 weeks
Title
Skin hydration (SH)
Description
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.
Time Frame
12 weeks
Title
Skin hydration (SH)
Description
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.
Time Frame
16 weeks
Title
Adverse event
Description
Adverse event will be assessed in the study period
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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;
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cho Wing Lo
Phone
35053476
Email
louislo@cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhixiu Lin
Organizational Affiliation
Integrative Medical Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Chinese Medicine
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhixiu LIN
Phone
28733252
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Modified Huang-Lian-Jie-Du Decoction (MHLJDD) for Atopic Dermatitis in Children
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