Efficacy and Safety of Runzaozhiyang Lotion for Chronic Hand Eczema: Protocol for a Randomized Controlled Trial
Bibliographic record
Abstract
Background: Chronic hand eczema (CHE) is a prevalent inflammatory skin disease in clinical practice. Guidelines recommend the use of topical medications, including corticosteroids and calcineurin inhibitors; however, prolonged use of these drugs may result in adverse effects, such as skin atrophy, drug tolerance, and rebound phenomena. Moreover, these medications exhibit limited efficacy in managing chronic hypertrophic hand eczema. Traditional Chinese medicine (TCM) has a long history of treating patients. The Runzaozhiyang lotion (RZZYL) is often used in the Department of Dermatology of Guang'anmen Hospital, China Academy of Chinese Medical Sciences, for these patients, with marked efficacy on symptoms, keratinization, hypertrophy, and pruritus improvements. Nonetheless, there is still no high-quality evidence from evidence-based medicine to prove the effectiveness and safety of CHE treatment. Objective: This study aimed to examine the efficacy and safety of a classic Chinese herbal prescription, RZZYL, for CHE and to provide a different treatment option for patients with hand eczema who are resistant to conventional Western pharmaceutical treatments. Methods: This study is a clinical trial characterized as randomized, double-blind, double-dummy, and positive drug-controlled. A total of 122 patients diagnosed with CHE have been randomized and allocated in a 1:1 ratio into 2 distinct groups, with one receiving the intervention and the other serving as the control. Participants in the intervention group will receive RZZYL granules along with a placebo cream of mometasone furoate, whereas the control group will get mometasone furoate cream in combination with a placebo for RZZYL granule. Both groups will be treated with either the active drug or a placebo for 4 weeks. The primary outcome metrics are 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). The outcomes will be assessed at the start of the study and again at 2 and 4 weeks after the treatment period. Results: The study will be conducted according to the guidelines and regulations approved by the participating institutions. Recruitment is expected to commence in March 2025 and conclude in March 2026. Data collection is anticipated to be completed by June 2026, with the study expected to conclude in August 2026. Conclusions: This protocol addresses the limitations of previous research and aims to explore the efficacy and safety of RZZYL in treating CHE through a higher-quality clinical study. It seeks to provide additional treatment options for patients with CHE who are resistant to or have poor responses to current therapies.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.028 | 0.021 |
| Meta-epidemiology (narrow) | 0.007 | 0.003 |
| Meta-epidemiology (broad) | 0.014 | 0.006 |
| Bibliometrics | 0.003 | 0.003 |
| Science and technology studies | 0.003 | 0.004 |
| Scholarly communication | 0.004 | 0.004 |
| Open science | 0.004 | 0.002 |
| Research integrity | 0.007 | 0.007 |
| Insufficient payload (model declined to judge) | 0.064 | 0.009 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".