Gelonghui September 27?300357.SZ announced that recently, "Dermatitis Diagnostic Patch 01" developed by Zhejiang Shiwu Biotechnology Co., Ltd. has completed "a clinical study to explore the tolerance of Dermatitis Diagnostic Patch 01 in Chinese healthy volunteers" and obtained a summary report of Phase I clinical trials.
The results of safety evaluation showed that the adverse events in the four dose groups were mild (grade 1) and moderate (grade 2), and there were no adverse events or serious adverse events leading to withdrawal. The average irritation score of potassium dichromate diaphragm was higher than that of nickel sulfate diaphragm, cobalt chloride diaphragm, negative diaphragm 1, non-diaphragm and control drugs, but the average stimulation score of each dose group was less than 3 points (that is, the need for clinical concern in the FDA guidelines). After safety evaluation, it was considered that it had little effect on the whole body. The results of exploratory evaluation showed that the concentrations of three metal ions in volunteers in dose group 3 were lower than the quantitative detection limit (10ng/ml) before and after administration, indicating that there was no significant change in metal ions after administration.
To sum up, in this study, four different doses of dermatitis diagnostic patch 01 patch were used to test healthy volunteers with good safety. The researchers believe that the four doses of products can be used in follow-up clinical studies.