Can BSZY Cream Reduce Symptoms of Facial Atopic Dermatitis?

Image Credit: © Beauty Agent Studio - stock.adobe.com

Affecting a significant proportion of both children and adults, atopic dermatitis (AD), particularly atopic facial dermatitis, presents treatment challenges due to its location and recurrent nature. Current therapies, including topical corticosteroids (TCSs) and topical calcineurin inhibitors (TCIs), primarily focus on symptom management but often have limitations due to adverse effects.^1,2 BiShengZhiYan (BSZY) cream, a novel non-hormonal topical agent, has shown promise in improving skin barrier function. A recent study (NCT05792826) is examining the clinical trial design investigating the efficacy and safety of BSZY cream in treating mild to moderate atopic facial dermatitis.³

Introduction

AD is prevalent among both children (10 to 20%) and adults (5 to 10%), with most cases classified as mild to moderate. The pathogenesis remains unclear, and available treatments focus on symptom control rather than disease modification.⁴ TCSs, though effective, may compromise the skin barrier and cause adverse reactions such as atrophy, telangiectasia, and rosacea.² Consequently, researchers noted there is an urgent need for alternative treatments that restore skin barrier integrity while minimizing adverse effects.

Study Rationale and Objectives

BSZY cream, containing MossCellTec, PL-Ceramide, and PL-PhytoSLC, has demonstrated skin barrier repair properties in preliminary studies. The randomized, double-blind, controlled trial aims to evaluate the efficacy and safety of BSZY cream in comparison to an emulsion-based placebo for treating mild to moderate atopic facial dermatitis.

Methods

Study Design

This single-center trial, approved by the ethics committee of Shanghai University of Traditional Chinese Medicine’s Yueyang Hospital, commenced in June 2023 and is scheduled to conclude in March 2025. A total of 130 participants with AD were enrolled and randomized into BSZY or placebo groups.

Inclusion and Exclusion Criteria

Participants must meet the Chinese Atopic Dermatitis Treatment Guidelines diagnostic criteria, be at least 18 years old, and have facial AD manifestations. Exclusion criteria include severe AD (SCORAD>50), pregnancy, autoimmune disorders, recent immunosuppressive therapy, and other confounding dermatological conditions.

Interventions

Participants receive BSZY cream or placebo twice daily for 4 weeks. They are instructed to avoid prolonged sun exposure and refrain from using additional skincare products during the study period.

Outcome Measures

Primary outcomes include changes in Scoring Atopic Dermatitis (SCORAD) index. Secondary outcomes involve clinical dermatologist evaluations and patient-reported assessments of erythema, papules, edema, and desquamation. Safety indicators include documentation of adverse events.

Statistical Analysis

Sample size estimation is based on previous studies, with an expected dropout rate of 20%. The intention-to-treat approach will be applied, using paired t-tests or Wilcoxon rank-sum tests for analysis. A p-value <0.05 will denote statistical significance.

Discussion

Managing atopic facial dermatitis remains challenging due to the adverse effects of conventional treatments. BSZY cream, designed to enhance skin barrier function without hormonal components, may provide an alternative. Moisturizers are essential in AD management, but clinical studies evaluating their efficacy specifically for atopic facial dermatitis are limited. This trial addresses that gap by assessing BSZY cream’s potential therapeutic benefits beyond simple moisturization.

Strengths and Limitations

This study’s robust methodology, including randomization and double-blind design, ensures high-quality evidence. However, its limitations include a single-center setting and a short follow-up period. Researchers suggested future research should explore long-term effects and broader patient populations.

Conclusion

This trial will provide valuable data on BSZY cream’s role in managing mild to moderate atopic facial dermatitis. The findings could inform future dermatological treatment strategies and support the development of non-hormonal skin barrier therapies.

References

1. Reed B, Blaiss MS. The burden of atopic dermatitis. Allergy Asthma Proc. 2018;39(6):406-410. doi:10.2500/aap.2018.39.4175
2. Kulthanan K, Tuchinda P, Nitiyarom R, et al. Clinical practice guidelines for the diagnosis and management of atopic dermatitis. Asian Pac J Allergy Immunol. 2021;39(3):145-155. doi:10.12932/AP-010221-1050
3. Wang P, Wei X, Cheng L, et al. Efficacy and safety of BSZY cream for mild-to-moderate atopic facial dermatitis: protocol of a randomised, double-blind, controlled trial. BMJ Open. 2025;15(3):e087149. Published 2025 Mar 22. doi:10.1136/bmjopen-2024-087149
4. Sayaseng KY, Vernon P. Pathophysiology and management of mild to moderate pediatric atopic dermatitis. J Pediatr Health Care. 2018;32(2):S2-S12. doi:10.1016/j.pedhc.2017.10.002