A single‐center, randomized, controlled study on the efficacy of niacinamide‐containing body emollients combined with cleansing gel in the treatment of mild atopic dermatitis

OBJECTIVE: To observe the effect of niacinamide‐containing body emollients combined with a cleansing gel on the clinical symptoms of mild atopic dermatitis (AD) in adults. METHODS: From July 2022 to January 2023, adults with mild AD were enrolled at Huashan Hospital Affiliated to Fudan University using single‐center, randomized and placebo‐controlled methods. They were divided into three groups: the control group, treatment group 1 (T1) receiving niacinamide‐containing body emollients alone, and treatment group 2 (T2) receiving emollients plus niacinamide‐containing cleansing gel. All patients were orally administered 10 mg of ebastine tablets daily. AD severity (SCORAD score), peak pruritus numeric rating scale (PP‐NRS), patient‐oriented measure of eczema (POEM), dermatological quality of life index (DLQI) score, transepidermal water loss (TEWL), and stratum corneum water content (SCWC) were measured by the same dermatologist at days 0, 7, 14, and 28. RESULTS: A total of 122 patients were enrolled, including 38 in the control group, 42 in the T1 group and 42 in the T2 group. There were no obvious adverse reactions at the end of the study and the clinical scores and stratum corneum barrier of all the groups improved significantly relative to baseline. The SCORAD, PP‐NRS, DLQI, TEWL and SCWC scores in T1 group (12.43 ± 3, 3.3 ± 0.9, 7.1 ± 2.33, 17.1 ± 9.12, 67.2 ± 21.46, seperately) and T2 group (11.17 ± 3.26, 3 ± 1.3, 6.5 ± 2.11, 16.3 ± 9.12, 69.4 ± 24.52, seperately) were significantly improved than the control group(15.1 ± 3.64, 4.3 ± 1.7, 9.5 ± 2.46, 21.2 ± 9.47, 52.7 ± 22.43, seperately) at the endpoint of the study, while compared the POEM scores, only T2 group showed the difference with control group (5.2 ± 1.4 vs. 6 ± 1.6). The epidermal barrier parameters of TEWL and SCWC in the T2 group (17.57 ± 5.24, 66.46 ± 21.38, seperately) were significantly better than that of the T1 (19.96 ± 4.45, 56.45 ± 20.48, seperately) and control group(21.89 ± 7.03, 51.56 ± 16.58, seperately) on the 14th day of follow‐up. CONCLUSION: The use of niacinamide‐containing body emollients can significantly improve the clinical symptoms, quality of life, and skin barrier function in patients with mild AD. The addition of niacinamide‐containing cleansing gel can also affect the clinical efficacy at certain time points.