Clinical trial NCT05613062: 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
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 20
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: EASI score
timeFrame: 12 weeks
Secondary outcomes:
measure: EASI score
timeFrame: 6 weeks
measure: EASI score
timeFrame: 16 weeks
measure: CDLQI score
timeFrame: 12 weeks
measure: CDLQI score
timeFrame: 16 weeks
measure: POEM score
timeFrame: 12 weeks
measure: POEM score
timeFrame: 16 weeks
measure: Microbiome
timeFrame: 12 weeks
measure: Time of flare
timeFrame: 16 weeks
measure: The number of subjects reaches flare
timeFrame: 16 weeks
measure: Trans-epidermal water loss (TEWL)
timeFrame: 6 weeks
measure: Trans-epidermal water loss (TEWL)
timeFrame: 12 weeks
measure: Trans-epidermal water loss (TEWL)
timeFrame: 16 weeks
measure: Skin hydration (SH)
timeFrame: 6 weeks
measure: Skin hydration (SH)
timeFrame: 12 weeks
measure: Skin hydration (SH)
timeFrame: 16 weeks
measure: Adverse event
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: School of Chinese Medicine
Study officials:
affiliation: Integrative Medical Centre
name: Zhixiu Lin
role: PRINCIPAL_INVESTIGATOR
References: