Efficacy and Safety of Haidebao Body Lotion in Patients With Mild Atopic Dermatitis: Protocol for a Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial
Bibliographic record
Abstract
BACKGROUND: Atopic dermatitis (AD) is a chronic, relapsing skin condition that significantly impacts patients' quality of life. In clinical practice, AD is commonly managed through the use of emollients and topical corticosteroids. Haidebao Body Lotion (HBL) incorporated with calcium-based antimicrobial peptide compounds (CAPCS) has demonstrated clinical benefits for patients with mild AD, but there is a lack of high-quality clinical trial evidence. OBJECTIVE: In this study, we will implement a multicenter, double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of HBL incorporated with CAPCS as an adjunctive therapy in ameliorating mild AD. METHODS: This multicenter, double blind, randomized, placebo-controlled trial will recruit 200 eligible participants from 10 hospitals in China from October 2023 to October 2025. In this study, AD will be confirmed in accordance with Williams diagnostic criteria, and patients with mild AD, aged 18-55 years, who provide signed informed consent will be enrolled. However, patients who are pregnant, have serious underlying diseases, have communication barriers, and violate medication regulations will be excluded. The 200 patients will be randomly assigned (1:1) to a treatment group (HBL with CAPCS; n=100, 50%) and a control group (HBL without CAPCS, placebo; n=100, 50%), and each participant will receive 3 sessions of treatments per day for 4 weeks. The primary outcome is the proportion of patients who achieve at least 60% improvement in the Eczema Area and Severity Index (EASI) score from baseline to week 2. The secondary outcomes include the Numeric Rating Scale (NRS), EASI50, EASI60, and Dermatology Life Quality Index (DLQI) scores at weeks 2 and 4, as well as adherence and adverse events. The full analysis set (FAS) and the per protocol set (PPS) will be analyzed using SAS 9.3 software, and missing data will be processed using the multiple imputation method. In this study, P<.05 is considered statistically significant. RESULTS: Participant recruitment began in January 2024. As of May 2025, we enrolled 180 patients, with 160 (88.9%) completing the 2-week follow-up. Data collection and management are still ongoing, and data analysis has not yet been performed. CONCLUSIONS: This study will evaluate the clinical efficacy and safety of HBL incorporated with CAPCS in the treatment of patients with mild AD. If treatment efficacy is proven, HBL incorporated with CAPCS could be clinically used as an adjunctive therapy in ameliorating mild AD. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/71255.
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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 | 0.025 | 0.019 |
| Meta-epidemiology (narrow) | 0.007 | 0.003 |
| Meta-epidemiology (broad) | 0.011 | 0.005 |
| Bibliometrics | 0.002 | 0.002 |
| Science and technology studies | 0.004 | 0.004 |
| Scholarly communication | 0.003 | 0.004 |
| Open science | 0.004 | 0.002 |
| Research integrity | 0.007 | 0.007 |
| Insufficient payload (model declined to judge) | 0.042 | 0.008 |
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".