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Nakagami H, Sugimoto K, Ishikawa T, et al. Physician-initiated clinical study of limb ulcers treated with a functional peptide, SR-0379: from discovery to a randomized, double-blind, placebo-controlled trial. NPJ Aging Mech Dis. 2018;4:2doi: 10.1038/s41514-018-0021-7.
Nakagami, H., Sugimoto, K., Ishikawa, T., Fujimoto, T., Yamaoka, T., Hayashi, M., Kiyohara, E., Ando, H., Terabe, Y., Takami, Y., Yamamoto, K., Takeya, Y., Takemoto, M., Koshizaka, M., Ebihara, T., Nakamura, A., Nishikawa, M., Yao, X. J., Hanaoka, H., Katayama, I., Yokote, K., & Rakugi, H. (2018). Physician-initiated clinical study of limb ulcers treated with a functional peptide, SR-0379: from discovery to a randomized, double-blind, placebo-controlled trial. NPJ aging and mechanisms of disease, 42. https://doi.org/10.1038/s41514-018-0021-7
Nakagami, Hironori, et al. "Physician-initiated clinical study of limb ulcers treated with a functional peptide, SR-0379: from discovery to a randomized, double-blind, placebo-controlled trial." NPJ aging and mechanisms of disease vol. 4 (2018): 2. doi: https://doi.org/10.1038/s41514-018-0021-7
Nakagami H, Sugimoto K, Ishikawa T, Fujimoto T, Yamaoka T, Hayashi M, Kiyohara E, Ando H, Terabe Y, Takami Y, Yamamoto K, Takeya Y, Takemoto M, Koshizaka M, Ebihara T, Nakamura A, Nishikawa M, Yao XJ, Hanaoka H, Katayama I, Yokote K, Rakugi H. Physician-initiated clinical study of limb ulcers treated with a functional peptide, SR-0379: from discovery to a randomized, double-blind, placebo-controlled trial. NPJ Aging Mech Dis. 2018 Feb 13;4:2. doi: 10.1038/s41514-018-0021-7. eCollection 2018. PMID: 29449960; PMCID: PMC5809414.
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NPJ Aging Mech Dis. 2018 Feb 13;4:2. doi: 10.1038/s41514-018-0021-7. eCollection 2018.

Physician-initiated clinical study of limb ulcers treated with a functional peptide, SR-0379: from discovery to a randomized, double-blind, placebo-controlled trial.

NPJ aging and mechanisms of disease

Hironori Nakagami, Ken Sugimoto, Takahiro Ishikawa, Taku Fujimoto, Toshifumi Yamaoka, Misa Hayashi, Eiji Kiyohara, Hiroshi Ando, Yuta Terabe, Yoichi Takami, Koichi Yamamoto, Yasushi Takeya, Minoru Takemoto, Masaya Koshizaka, Tamotsu Ebihara, Ayumi Nakamura, Mitsunori Nishikawa, Xiang Jing Yao, Hideki Hanaoka, Ichiro Katayama, Koutaro Yokote, Hiromi Rakugi

Affiliations

  1. 1Department of Health Development and Medicine, Osaka University Graduate School of Medicine, Suita, Japan.
  2. 2Department of Geriatric and General Medicine, Osaka University Graduate School of Medicine, Suita, Japan.
  3. 3Department of Clinical Cell Biology and Medicine, Chiba University Graduate School of Medicine, Chiba, Japan.
  4. 4Department of Dermatology, Osaka University Graduate School of Medicine, Suita, Japan.
  5. Department of Cardiology, Kasukabe Chuo General Hospital, Saitama, Japan.
  6. Plastic and Reconstructive Surgery, Tokyo Nishi Tokushukai Hospital, Nishi-tokyo, Japan.
  7. 7Department of Diabetes, Metabolism and Endocrinology, School of Medicine, International University of Health and Welfare, Otawara, Japan.
  8. 8Department of Dermatology, Keio University School of Medicine, Tokyo, Japan.
  9. 9Department of Pharmacy, Osaka University Hospital, Suita, Japan.
  10. 10Department of Medical Innovation, Osaka University Hospital, Suita, Japan.
  11. 11Clinical Research Center, Chiba University Hospital, Chiba, Japan.

PMID: 29449960 PMCID: PMC5809414 DOI: 10.1038/s41514-018-0021-7

Abstract

SR-0379 is a functional peptide that has wound healing effect with anti-microbial action, making it an ideal drug to prevent infection. To evaluate the safety, efficacy, and pharmacokinetics of SR-0379 for the treatment of leg ulcers, a physician-initiated, phase I/IIa, first-in-patient clinical study was designed. A multi-center, double-blind, randomized clinical study was conducted from October 2015 to September 2016. The inclusion criteria for leg ulcers were (1) diabetes or critical limb ischemia and (2) wound size <6 cm in diameter. Twelve patients were randomized into four groups and administered 0.02%, 0.1%, or 0.5% SR-0379 or placebo treatment on skin ulcers once per day for 28 days. Efficiency was evaluated by determining the rate of wound size reduction as a primary endpoint at 4 weeks after the first treatment compared with the pre-treatment wound size. As a secondary endpoint, the DESIGN-R score index, time to wound closure, and the 50% wound size reduction ratio were also evaluated. The safety of SR-0379 was evaluated during the study period. In the evaluation of efficiency, the skin ulcer reduction rates at the last evaluation were 44.73% for the 0.02% SR-0379 group, 68.25% for the 0.1% group, and 71.61% for the 0.5% group, compared with 9.95% for the placebo group. Six adverse events were reported in four patients, of which one occurred in the placebo group, and causal relationships to study drugs were denied for all six events. Treatment with SR-0379 for chronic leg ulcers was safe, well tolerated, and effective.

Conflict of interest statement

Department of Health Development and Medicine (Hironori Nakagami) is endowed department supported by Anges MG, Daicel, and Mitsubishi-Tanabe Pharmaceuticals. This study is partially supported by Funpe

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