[Translation] A randomized, double-blind, placebo-controlled, parallel-center, phase II clinical trial of ZYY-742 gel for the treatment of anti-EGFR-related papulopustular rash (lung meridian wind-heat syndrome).
1.探索ZYY-742凝胶治疗抗EGFR靶向药物相关丘疹脓疱型皮疹(肺经风热证),改善局部瘙痒、疼痛等症状的有效性、安全性以及疗效特色;
2.通过多剂量对照探索ZYY-742凝胶治疗抗EGFR靶向药物相关丘疹脓疱型皮疹(肺经风热证)的适用剂量;
3.为后续为开展Ⅲ期临床试验提以及申报中药新药1.1类新药注册(IND)积累循证医学证据。
[Translation] 1. To explore the efficacy, safety, and unique therapeutic characteristics of ZYY-742 gel in treating anti-EGFR-targeted drug-related papulopustular rashes (lung meridian wind-heat syndrome), improving symptoms such as local itching and pain;
2. To explore the appropriate dosage of ZYY-742 gel in treating anti-EGFR-targeted drug-related papulopustular rashes (lung meridian wind-heat syndrome) through multi-dose control;
3. To accumulate evidence-based medical evidence for subsequent Phase III clinical trials and for applying for Investigational New Drug (IND) registration (Class 1.1) for traditional Chinese medicine.