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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05613062
• Other study ID #: AD HLJDD study
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: April 11, 2023
• Est. completion date: June 2024

Study information

• Verified date: July 2023
• Source: Chinese University of Hong Kong
• Contact: Cho Wing Lo
• Phone: 35053476
• Email: louislo[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Modified Huang-Lian-Jie-Du Decoction (MHLJDD)
Chinese medicine granules for 12 weeks twice daily
• Placebo
Placebo granules for 12 weeks twice daily

Locations

Country	Name	City	State
Hong Kong	School of Chinese Medicine	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Time of flare	The time to reach flare (defined as major exacerbation disease increase > 50% of baseline EASI)	16 weeks
Secondary	The number of subjects reaches flare	The number of subjects reaches flare (defined as major exacerbation disease increase > 50% of baseline EASI)	16 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Adverse event	Adverse event will be assessed in the study period	16 weeks