Efficacy and safety of propranolol cream in infantile hemangioma: A prospective pilot study

Journal of Pharmacological Sciences

卷:149

Eisaku Okada¹  Yasuharu Kashiwagura²  Shinya Uchida³  Satoru Iwashima⁴  Shinichiro Sano⁴  Eiko Nagata⁵  Kazuo Umemura⁶  Naoki Inui⁷  Hiroshi Watanabe⁷  Akio Hakamata⁸  Keiichi Odagiri⁸  Satoshi Hayano⁹  Shimako Tanaka⁹  Mitsuhiro Nishida¹⁰ 

[1] Corresponding author. Center for Clinical Research, Hamamatsu University Hospital, 1-20-1 Handayama, Higashi-ward, Hamamatsu, 431-3192, Japan. Fax: [phone];

[2] Department of Pediatrics, Hamamatsu University School of Medicine, Hamamatsu, Japan;

[3] Fujimi Children's Clinic, Iwata, Japan;

[4] Science, School of Pharmaceutical Sciences, University of Shizuoka, Shizuoka, Japan;

[5] Center for Clinical Research, Hamamatsu University Hospital, Hamamatsu, Japan;

[6] Department of Clinical Pharmacology and Therapeutics, Hamamatsu University School of Medicine, Hamamatsu, Japan;

[7] Department of Pediatrics, Chutoen General Medical Center, Kakegawa, Japan;

[8] Department of Pediatrics, Hamamatsu Medical Center, Hamamatsu, Japan;

[9] Department of Pharmacy Practice &

[10] Division of Community Health and Preventive Medicine, Hamamatsu University School of Medicine, Hamamatsu, Japan;

关键词: Propranolol;    Cream;    Infantile hemangioma;    Pilot study;    Infants;   

DOI  :  

来源: DOAJ

【 摘 要 】

Infantile hemangioma (IH) is a common tumor in infants that gradually resolves and is often untreated. However, for cosmetic reasons, parents often opt for treatment. Oral propranolol, the first-line therapy for IH, is sometimes associated with several side effects, including hypotension, bradycardia, and hypoglycemia. No clinical studies on topical propranolol have been conducted using standardized procedures. We evaluated the efficacy and safety of topical propranolol in patients with IH. This multicenter, prospective pilot study was conducted from June 2019 to October 2020 and involved eight Japanese infants aged 35–150 days with proliferating IH. Patients were treated with 5% propranolol cream twice daily. We examined the efficacy rate based on central evaluation (complete or near-complete healing of the target hemangioma) at weeks 24 and 12, respectively, compared to baseline values. The efficacy rate at week 24 was 68.8% (95% confidence interval: 44.1–85.9%). The surface area, maximum diameter, and color intensity of the target IH decreased over time. Adverse event and drug-related adverse event rates were 87.5% and 0%, respectively. Propranolol cream may be effective and safe in Japanese patients with IH and may be considered a first-choice treatment for small and superficial IHs in cosmetically problematic areas.

【 授权许可】

Unknown