Modified Huang-Lian-Jie-Du Decoction (MHLJDD) for Atopic Dermatitis in Children

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.

Study Overview

• Status: Recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Modified Huang-Lian-Jie-Du Decoction (MHLJDD); Drug: Placebo

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Cho Wing Lo; Phone Number: 35053476; Email: louislo@cuhk.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • School of Chinese Medicine
    • Contact: Zhixiu LIN; Phone Number: 28733252

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo granules for 12 weeks twice daily
Experimental: Active treatment (Modified Huang-Lian-Jie-Du Decoction (MHLJDD)); Chinese medicine	Drug: Modified Huang-Lian-Jie-Du Decoction (MHLJDD); Chinese medicine granules for 12 weeks twice daily; Other Names: Chinese medicine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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.	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.	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.	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.	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.	12 weeks
Time of flare	The time to reach flare (defined as major exacerbation disease increase > 50% of baseline EASI)	16 weeks
The number of subjects reaches flare	The number of subjects reaches flare (defined as major exacerbation disease increase > 50% of baseline EASI)	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.	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.	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.	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.	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.	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.	16 weeks
Adverse event	Adverse event will be assessed in the study period	16 weeks

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Zhixiu Lin, Integrative Medical Centre

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: September 29, 2022
• First Submitted That Met QC Criteria: November 10, 2022
• First Posted (Actual): November 14, 2022

Study Record Updates

• Last Update Posted (Actual): July 7, 2023
• Last Update Submitted That Met QC Criteria: July 6, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Oren gedoku to
• Other Study ID Numbers: AD HLJDD study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No