Abstract: 【Abstract】 Objective To investigate the clinical efficacy and safety of a baby smoothing and special caring cream in reducing the recurrence of atopic dermatitis （AD） in infancy. Methods A randomized controlled trial was conducted. Children with moderate AD （with overall investigator's global assessment ［IGA］ scores of 3 - < 4） were enrolled from Shunyi Maternal and Children′s Hospital of Beijing Children′s Hospital from April 2021 to June 2024. During the induction period, all children were topically treated with 0.1% hydrocortisone butyrate cream twice daily on the lesional skin, as well as with a baby smoothing and special caring cream at least twice daily throughout the body; at the 2-week visit, patients with an IGA score of ≤ 1 point entered the maintenance phase, while those with an IGA score of > 1 point continued the treatment for another 2 weeks; at the 4-week visit, patients with an IGA score of ≤ 1 point entered the maintenance phase, while those still with an IGA score of > 1 point were withdrawn from the study, and received conventional treatment. Patients who entered the maintenance period were randomly divided into the test group and the control group in a 1∶1 ratio using a random number table. In the test group, the hydrocortisone butyrate cream was discontinued, while the baby smoothing and special caring cream was continued twice daily for 8 consecutive weeks; in the control group, both the hydrocortisone butyrate cream and the baby smoothing and special caring cream were discontinued. IGA and Scoring AD （SCORAD） scores were assessed by clinicians at weeks 4 and 8 in the maintenance phase, while the patient-oriented eczema measure （POEM） score was evaluated weekly by patients' parents. The Kaplan-Meier survival analysis and Breslow test were used to compare recurrence rates in the two groups （the primary efficacy outcome）, and a generalized estimating equation model was used to evaluate the changes in IGA, SCORAD, and POEM scores in the two groups （the secondary efficacy outcomes）. Adverse reactions were monitored throughout the study to evaluate safety. Results A total of 68 children with moderate AD aged from 3 months to 2 years were included. There were 38 females and 30 males, aged 11.72 ± 6.03 months. Fifty-two patients entered the maintenance phase; 2 were lost to follow-up, and 50 were included in the per-protocol set, with 28 in the test group and 22 in the control group. The recurrence rate during the maintenance phase was 7.14% （2/28） in the test group and 31.82% （7/22） in the control group, showing a significant difference between the two groups （χ2 = 5.08, P = 0.032）. At weeks 4 and 8 in the maintenance phase, the IGA scores were significantly lower in the test group than in the control group （Wald χ2 = 5.06, P = 0.024）, whereas the SCORAD scores showed no significant differences between the two groups （Wald χ2 = 2.92, P = 0.087）. During weeks 1–8 in the maintenance phase, the POEM scores showed no significant differences between the two groups or over time （both P > 0.05）, while the two groups showed different change trends in POEM scores over time （Wald χ2interaction = 55.37, Pinteraction < 0.001）. Throughout the entire study period, no adverse reactions were observed among all 68 subjects. Conclusion With a high safety profile, the baby smoothing and special caring cream could reduce the recurrence rate during the maintenance phase, showing promise as an adjuvant therapy for the maintenance treatment of AD in infancy, and is worthy of clinical application.

Key words: Dermatitis, atopic, Infancy, Skin barrier, Moisturizing emollient, Maintenance therapy, Recurrence