Hironori Nakagami1, Ken Sugimoto2, Takahiro Ishikawa3, Masaya Koshizaka3, Taku Fujimoto2, Eiji Kiyohara4, Misa Hayashi4, Yukinobu Nakagawa4, Hiroshi Ando5, Yuta Terabe6, Yoichi Takami2, Koichi Yamamoto2, Yasushi Takeya2, Minoru Takemoto3,7, Tamotsu Ebihara8, Ayumi Nakamura9,10, Mitsunori Nishikawa9, Xiang Jing Yao10, Hideki Hanaoka11, Koutaro Yokote3, Hiromi Rakugi2. 1. Department of Health Development and Medicine, Osaka University Graduate School of Medicine, Suita, Osaka, Japan. 2. Department of Geriatric and General Medicine, Osaka University Graduate School of Medicine, Suita, Osaka, Japan. 3. Department of Endocrinology, Hematology and Gerontology, Chiba University Graduate School of Medicine, Chiba, Japan. 4. Department of Dermatology, Osaka University Graduate School of Medicine, Suita, Osaka, Japan. 5. Department of Cardiology, Kasukabe Chuo General Hospital, Kasukabe, Japan. 6. Plastic and Reconstructive Surgery, Tokyo Nishi Tokushukai Hospital, Akishima, Japan. 7. Department of University, School of Medicine, International University of Health and Welfare, Department of Diabetes, Metabolism and Endocrinology, Narita, Japan. 8. Department of Dermatology, Saiseikai Central Hospital, Tokyo, Japan. 9. Department of Pharmacy, Osaka University Hospital, Suita, Japan. 10. Department of Medical Innovation, Osaka University Hospital, Suita, Japan. 11. Clinical Research Center, Chiba University Hospital, Chiba, Japan.
Abstract
AIM: An investigator-initiated clinical study was carried out to evaluate the therapeutic potency of SR-0379 for the treatment of leg ulcers in patients with Werner syndrome. METHODS: A multicenter, open-label study was carried out from September 2017 to February 2018. The inclusion criteria for leg ulcers were: (i) leg ulcers in patients with Werner syndrome, diabetes or critical limb ischemia/venous stasis; and (ii) a wound size of >1 cm and <6 cm in diameter. Four individuals with Werner syndrome and diabetic ulcers, respectively, were enrolled. SR-0379 (0.1%) was sprayed on skin ulcers once per day for 4 weeks. Efficacy was evaluated by determining the rate of wound size reduction as a primary end-point at 4 weeks after the first treatment compared with the pretreatment wound size. As secondary end-points, the DESIGN-R score index, the 50% wound size reduction ratio, time to wound closure and quantification of wound bacteria were also evaluated. The safety of SR-0379 was evaluated during the study period. RESULTS: The reduction rate of ulcer size treated with 0.1% SR-0379 was 22.90% (mean) in the Werner syndrome ulcers group (n = 4) and 35.70% (mean) in the diabetic ulcers group (n = 4), respectively. The DESIGN-R score decreased by 4.0 points in the Werner syndrome ulcers group and 4.3 points in the diabetic ulcers group. Two mild adverse events were reported in two patients, and causal relationships were denied in any events. CONCLUSION: Treatment with SR-0379 was safe, well-tolerated, and effective for leg ulcers of both Werner syndrome and diabetes patients. Geriatr Gerontol Int 2019; 19: 1118-1123.
AIM: An investigator-initiated clinical study was carried out to evaluate the therapeutic potency of SR-0379 for the treatment of leg ulcers in patients with Werner syndrome. METHODS: A multicenter, open-label study was carried out from September 2017 to February 2018. The inclusion criteria for leg ulcers were: (i) leg ulcers in patients with Werner syndrome, diabetes or critical limb ischemia/venous stasis; and (ii) a wound size of >1 cm and <6 cm in diameter. Four individuals with Werner syndrome and diabetic ulcers, respectively, were enrolled. SR-0379 (0.1%) was sprayed on skin ulcers once per day for 4 weeks. Efficacy was evaluated by determining the rate of wound size reduction as a primary end-point at 4 weeks after the first treatment compared with the pretreatment wound size. As secondary end-points, the DESIGN-R score index, the 50% wound size reduction ratio, time to wound closure and quantification of wound bacteria were also evaluated. The safety of SR-0379 was evaluated during the study period. RESULTS: The reduction rate of ulcer size treated with 0.1% SR-0379 was 22.90% (mean) in the Werner syndrome ulcers group (n = 4) and 35.70% (mean) in the diabetic ulcers group (n = 4), respectively. The DESIGN-R score decreased by 4.0 points in the Werner syndrome ulcers group and 4.3 points in the diabetic ulcers group. Two mild adverse events were reported in two patients, and causal relationships were denied in any events. CONCLUSION: Treatment with SR-0379 was safe, well-tolerated, and effective for leg ulcers of both Werner syndrome and diabetespatients. Geriatr Gerontol Int 2019; 19: 1118-1123.