Project Overview
Drug Name: CKBA Cream
Registration Classification: Chemical Drug Class 1
Indication: Rosacea
Applicant: Jiangsu Bochuangyuan Biopharmaceutical Technology Co., Ltd.
Main Trial Institution: West China Hospital, Sichuan University
Clinical Trial Information
Rosacea is a chronic recurrent inflammatory disease primarily affecting the facial vascular, nerve, and follicular sebaceous gland units. Epidemiological studies indicate a prevalence of 3.36% to 3.48% in the Chinese population. As a disfiguring skin disease, negative emotions such as anxiety and depression are common among rosacea patients, who have an urgent desire for treatment. The pathogenesis and triggers of rosacea are not yet fully understood, making treatment a complex process that often requires long-term maintenance therapy to control symptoms. Recent FDA-approved medications for rosacea, such as ivermectin cream and minocycline hydrochloride sustained-release capsules, are repurposed old drugs, and clinical observations show limited efficacy, poor tolerance, and high recurrence rates, indicating unmet treatment needs.