Moderate to severe acne vulgaris
Conditions
Interventions
ASC40 (dinifastat) tablets 50 mg dose group:ASC40 (Denufosfamide) tablets 50 mg once daily
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Participants who have successfully completed a 12-week Phase III study of ASC40-303; 2.Have fully understood this research and voluntarily signed the informed consent; 3.The fertile male and female subjects of reproductive age agreed to use effective contraception from the time they signed the informed consent until 3 months after the final administration of the experimental drug; 4.Subjects are willing and able to complete the study, understand and comply with the study requirements, comply with the study requirements restrictions and related education, use the investigational drug as prescribed by the physician, and follow up according to the study schedule.
Exclusion criteria
Exclusion criteria: 1.Discontinue participation in the ASC40-303 Phase III study for any reason. 2.Are receiving/planning to receive any systemic acne medications, systemic retinoids, systemic corticosteroids, or any androgen/antiandrogen therapy (e.g., testosterone, spironolactone); 3.Pregnant, nursing, or planning a pregnancy during the study period; 4.Have major complications (including clinically significant abnormalities in clinical laboratory tests), mental disorders, or other factors deemed unsuitable for study participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number and percentage of subjects with treatment-phase adverse events (TEAE);Number and percentage of subjects with a serious adverse event (SAE).;Number and percentage of subjects who discontinued due to adverse events.; | — |
Secondary
| Measure | Time frame |
|---|---|
| At the end of the visit, the number of people whose IGA rating had decreased by at least 2 points fr;Percentage change in total skin count at the end of the visit compared to the baseline period of the;Percentage change in total skin count at the end of the visit compared to the baseline period of the;At the end of the visit, the number of subjects with an IGA score of 3 or more dropped to an IGA sco; | — |
Countries
China
Contacts
Public ContactLeihong Xiang
Huashan Hospital, Fudan University
Outcome results
None listed