Atopic Dermatitis
Conditions
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.
Interventions
DRUGModified Huang-Lian-Jie-Du Decoction (MHLJDD)
Chinese medicine granules for 12 weeks twice daily
DRUGPlacebo
Placebo granules for 12 weeks twice daily
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EASI score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EASI score | 6 weeks | 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 |
| CDLQI score | 12 weeks | 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. |
| POEM score | 12 weeks | 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. |
| Microbiome | 12 weeks | 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 | 16 weeks | The time to reach flare (defined as major exacerbation disease increase \> 50% of baseline EASI) |
| The number of subjects reaches flare | 16 weeks | The number of subjects reaches flare (defined as major exacerbation disease increase \> 50% of baseline EASI) |
| Trans-epidermal water loss (TEWL) | 6 weeks | 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. |
| Skin hydration (SH) | 6 weeks | 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. |
| Adverse event | 16 weeks | Adverse event will be assessed in the study period |
Countries
Hong Kong
Contacts
PRINCIPAL_INVESTIGATORZhixiu Lin
Integrative Medical Centre
Outcome results
None listed