JMIR Publications

ABSTRACT

Background:

Eczema is a prevalent dermatological disorder marked by inflammation of the superficial dermis and epidermis, induced by many internal and environmental causes. Chronic hand eczema (CHE) denotes eczema confined to the hands, characterized by episodes occurring at least twice a year, or each episode last for over three months. Epidemiological studies indicate that the prevalence of hand eczema (HE) in the general population is 4.0%, with a lifetime prevalence reaching 14.5%. The enduring adverse effects of traditional pharmacological therapies have impeded their extensive clinical utilization. Consequently, the topical application of traditional Chinese medicine in the management of CHE possesses significant clinical potential.

Objective:

To evaluate the efficacy and safety of Runzaozhiyang lotion (RZZYL), a classic Chinese herbal prescription, for CHE.

Methods:

This study is a clinical trial characterized as randomized, double-blind, double-dummy, and placebo-controlled. A total of 122 patients diagnosed with chronic hand eczema (CHE) have been randomized and allocated in a 1:1 ratio into two distinct groups: one receiving the intervention and the other serving as the control. Participants in the intervention group will receive RZZYL granule along with a placebo cream of Mometasone Furoate (MFC), whereas the control group will get MFC in combination with a placebo for RZZYL granule. Both groups will undergo treatment with either the active medication or a placebo for a period of four weeks. The primary outcome metrics include the Hand Eczema Severity Index (HECSI) and the Numerical Rating Scales (NRS). Secondary outcome metrics consist of the target lesion area score, the Patient-Oriented Eczema Measure (POEM), the Dermatology Life Quality Index (DLQI), and the Investigator Global Assessment (IGA).

Results:

Assessments of outcomes will take place at the beginning of the study and then again at two weeks and four weeks following the treatment period.

Conclusions:

The purpose of this study is to explore the efficacy and safety of RZZYL in the treatment of chronic hand eczema. Clinical Trial: International Traditional Medicine Clinical Trial Registry ITMCTR2025000287.