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Completed

NCT Number: NCT05613062

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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

School of Chinese Medicine

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Modified Huang-Lian-Jie-Du Decoction (MHLJDD)

Drug

Chinese medicine granules for 12 weeks twice daily

Other names: Chinese medicine

Placebo

Drug

Placebo granules for 12 weeks twice daily

Primary outcomes

  1. 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.

Secondary outcomes

  1. EASI score

    Time frame: 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

  2. EASI score

    Time frame: 16 weeks

    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

  3. CDLQI score

    Time frame: 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.

  4. CDLQI score

    Time frame: 16 weeks

    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.

  5. POEM score

    Time frame: 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.

  6. POEM score

    Time frame: 16 weeks

    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.

  7. Microbiome

    Time frame: 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.

  8. Time of flare

    Time frame: 16 weeks

    The time to reach flare (defined as major exacerbation disease increase > 50% of baseline EASI)

  9. The number of subjects reaches flare

    Time frame: 16 weeks

    The number of subjects reaches flare (defined as major exacerbation disease increase > 50% of baseline EASI)

  10. Trans-epidermal water loss (TEWL)

    Time frame: 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.

  11. Trans-epidermal water loss (TEWL)

    Time frame: 12 weeks

    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.

  12. Trans-epidermal water loss (TEWL)

    Time frame: 16 weeks

    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.

  13. Skin hydration (SH)

    Time frame: 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.

  14. Skin hydration (SH)

    Time frame: 12 weeks

    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.

  15. Skin hydration (SH)

    Time frame: 16 weeks

    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.

  16. Adverse event

    Time frame: 16 weeks

    Adverse event will be assessed in the study period

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

A Randomized Placebo-Controlled Pilot Study of an Herbal Formula Modified Huang-Lian-Jie-Du Decoction (MHLJDD) for Atopic Dermatitis in Children

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 14, 2022
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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