李氏大藥廠(00950.HK)阿達帕林-克林黴素複方凝膠III期臨牀研究已成功完成招募1617名患者
格隆匯11月22日丨李氏大藥廠(00950.HK)公佈,於2019年11月22日,公司間接非全資附屬公司China Ophthalmology Focus Limited於中國進行的阿達帕林-克林黴素複方凝膠III期臨牀研究已成功完成招募患者。
此阿達帕林-克林黴素複方凝膠測試是一項在中國進行旳三期、多中心、隨機、單盲、平行分組、陽性對照臨牀研究。這項研究的目的是比較阿達帕林-克林黴素複方凝膠在治療中度至嚴重尋常性痤瘡相對單獨使用阿達帕林凝膠及單獨使用克林黴素凝膠的療效及安全性。阿達帕林及克林黴素一直有報道指出在治療痤瘡方面,兩者一起使用會有更好效果。這新配方混合兩種產品結合成單一凝膠,每天只需要使用一次,因此更為方便使用。
本次III期臨牀試驗的設計是在2017年成功完成II期研究後與中國藥品審評中心協商後的結果。本次研究涉及28個臨牀試驗中心,在中國招募合共1617名患者,其中包括95名年齡在12至18歲之間的青少年。
這是迄今為止在中國進行的最大規模皮膚病學研究,招募患者人數高達1617名,公司認為,混合阿達帕林(一種視黃酸受體(RAR)促進劑)與克林黴素(一種抗生素)的複方凝膠在治療中度至嚴重痤瘡方面比傳統療法更有效。
據悉,阿達帕林-克林黴素複方凝膠是COPFL開發中的專利產品,用於治療中度至嚴重尋常性痤瘡。阿達帕林是一種視黃酸受體(RAR)促進劑,可促進皮膚生長,而克林黴素是一種可阻止細菌蛋白質合成的抗生素。混合使用具有不同作用機制的阿達帕林與克林黴素,在治療痤瘡上比單獨使用其中一種成份更為有效。
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