Chinese Journal of Dermatology ›› 2022, Vol. 55 ›› Issue (10): 864-868.doi: 10.35541/cjd.20210729

• Original Articles • Previous Articles     Next Articles

Compound oleum lithospermi in improving clinical symptoms of mild to moderate diaper dermatitis: a multicenter, open-labeled, randomized controlled clinical study

Tian Jing1, Wei Fenglei2, Chen Ping3, Shu Hong4, Guo Yanping5, Ji Aihua6, Qian Qiufang7, Lu Yonghong8, Chen Jinping9, Li Yunling10, Yang Ting11, Wang Liuhui12, Chen Ji13, Song Li14, Yang Su15, Wang Xiangdong16, Qian Hua17, Han Xiuping18, Li Ping19, Ma Lin1   

  1. 1National Center for Children′s Health, Beijing Children′s Hospital, Capital Medical University, Beijing 100045, China; 2Dalian Women and Children′s Medical Group, Dalian 116012, Liaoning, China; 3Xuzhou Children′s Hospital, Xuzhou 221006, China; 4Kunming Children′s Hospital, Kunming 650103, China; 5The Sixth Affiliated Hospital of Harbin Medical University （Harbin Children′s Hospital）, Harbin 150010, China; 6Children′s Hospital Affiliated to Shandong University, Jinan 250022, China; 7Shanghai Children′s Hospital, Shanghai 200062, China; 8Chengdu Second People′s Hospital, Chengdu 610021, China; 9Guangzhou Women and Children′s Medical Center, Guangzhou 510120, China; 10The Children′s Hospital of Zhejiang University School of Medicine, Hangzhou 310005, China; 11Wuxi Children′s Hospital, Wuxi 214023, Jiangsu, China; 12The Children′s Hospital of Fudan University, Shanghai 201102, China; 13Shanghai Jiaotong University School of Medicine, Shanghai Children′s Medical Center, Shanghai 200127, China; 14Children′s Hospital Affiliated of Zhengzhou University, Zhengzhou 450053, China; 15Children′s Hospital of Nanjing Medical University, Nanjing 210008, China; 16Wuhan Hospital of Traditional Chinese and Western Medicine, Wuhan 430022, China; 17Children′s Hospital of Soochow University, Suzhou 215003, Jiangsu, China; 18Shengjing Hospital of China Medical University, Shenyang 110004, China; 19Shenzhen Children′s Hospital, Shenzhen 518038, China
    Tian Jing, Wei Fenglei, Chen Ping and Shu Hong contributed equally to this article
  • Received:2021-10-08 Revised:2022-06-08 Online:2022-10-15 Published:2022-10-08
  • Contact: Li Ping; Ma Lin E-mail:liping20081110@126.com; bch_maleen@aliyun.com
  • Supported by:
    National Natural Science Foundation of China （81673042）; Special Fund of the Pediatric Medical Coordinated Development Center of Beijing Municipal Administration of Hospitals （XTZD20180502）

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Abstract: 【Abstract】 Objective To evaluate clinical efficacy and safety of topical compound oleum lithospermi in the treatment of mild to moderate diaper dermatitis. Methods A multicenter, randomized, positive-drug parallel-controlled clinical trial was conducted in 19 hospitals from July 2019 to August 2020. Children aged 0 - 12 months with mild to moderate diaper dermatitis were enrolled and randomly divided into 2 groups using a random number table: test group topically treated with compound oleum lithospermi, and control group topically treated with zinc oxide cream. The treatment was carried out 6 - 8 times a day for 7 days. Visits were scheduled on days 0 and 7, and total response rate and clinical healing time were evaluated. Changes in the dermatitis family impact （DFI） score were compared between the test group and control group, and adverse events were recorded. Statistical analysis was carried out by using independent-sample t test for normally distributed continuous data, Wilcoxon rank sum test for non-normally distributed continuous data, and chi-square test or Fisher′s exact test for unordered categorical data; survival curves were drawn, and log-rank test was used for comparisons between two groups. Results A total of 343 children with diaper dermatitis were enrolled in this study. Among them, 31 children violated the protocol, so 312 were included in the per protocol set, including 157 in the test group and 155 in the control group, and all completed the visits on days 0 and 7. The total response rate was significantly higher in the test group （87.26%, 137/157） than in the control group （78.71%, 122/155; χ2 = 4.04, P = 0.044）. The clinical healing time was significantly shorter in the test group （5.33 days） than in the control group （6.13 days; χ2 = 4.67, P = 0.025）. After 7-day treatment, the DFI score significantly decreased in both the 2 groups compared with that before the treatment, but there was no significant difference in the DFI score between the 2 groups （test group: 4.02 ± 6.96, control group: 3.58 ± 5.90, Z = -0.39, P = 0.686）. The incidence of adverse events was 2.92% （5/171） and 5.45% （9/165） in the test group and control group respectively, and there was no significant difference between the 2 groups （χ2 = 0.03, P = 0.865）. Conclusion Compound oleum lithospermi can markedly reduce the clinical severity of diaper dermatitis, improve the total response rate, shorten the clinical treatment period, and improve the quality of life of children′s families with a favorable safety profile.

Key words: Treatment outcome, Compound oleum lithospermi, Diaper dermatitis, Randomized controlled clinical study