Analysis of common issues in phase Ⅰ clinical trials of topical semisolid dermatological preparations of traditional Chinese medicine
LI Shi-yu
YE Yu-jie
ZHU Zhu
MA Han-wen
YUAN Wei-an
HE Min
Abstract：Topical semisolid preparations represent the most prevalent dosage form of innovative dermatological preparations of traditional Chinese medicine(TCM).Due to their unique physicochemical properties,these formulations face multiple challenges during Phase Ⅰ clinical trials.Drawing from our research team's recent clinical trial experience,this paper systematically analyzed the common issues encountered throughout the clinical development process,ranging from protocol design to implementation practices,aiming to provide valuable references for advancing the development and clinical evaluation of innovative TCM semisolid preparations for topical dermatological application.
Keywords：traditional Chinese medicinesemisolid preparationstopical usephase Ⅰ clinical trials
Publication Date：2025-11-30
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：5( 2429-2433 )