[Translation] A multicenter, randomized, double-blind, placebo-controlled phase I/II clinical trial on the safety, tolerability and efficacy of topical Nocardia rubrum cell wall skeleton in the treatment of radiation-induced skin injuries
I期:
主要目的:评价不同剂量的外用红色诺卡氏菌细胞壁骨架在治疗放射性皮损伤研究参与者中的安全性和耐受性。
次要目的:评价不同剂量的外用红色诺卡氏菌细胞壁骨架在治疗放射性皮损伤研究参与者中的初步有效性。
II期:
主要目的:评价外用红色诺卡氏菌细胞壁骨架在治疗放射性皮损伤研究参与者中的有效性。
次要目的:评价外用红色诺卡氏菌细胞壁骨架在治疗放射性皮损伤研究参与者中的安全性。
[Translation] Phase I:
Primary objective: To evaluate the safety and tolerability of different doses of topical Nocardia rubrum cell wall skeleton in the treatment of radiation-induced skin injury study participants.
Secondary objective: To evaluate the preliminary effectiveness of different doses of topical Nocardia rubrum cell wall skeleton in the treatment of radiation-induced skin injury study participants.
Phase II:
Primary objective: To evaluate the effectiveness of topical Nocardia rubrum cell wall skeleton in the treatment of radiation-induced skin injury study participants.
Secondary objective: To evaluate the safety of topical Nocardia rubrum cell wall skeleton in the treatment of radiation-induced skin injury study participants.