Status:
COMPLETED
A Study to Evaluate the Safety and Efficacy of ASC40 (Denifanstat) Tablets in the Treatment of Patients With Moderate to Severe Acne Vulgaris
Lead Sponsor:
Ascletis Pharmaceuticals Co., Ltd.
Conditions:
Acne
Eligibility:
All Genders
18-40 years
Phase:
PHASE3
Brief Summary
This is a multicenter, randomized, double-blind, placebo-controlled Phase III study to evaluate the efficacy and safety of ASC40 (Denifanstat) tablets compared to placebo in the treatment of patients ...
Eligibility Criteria
Inclusion
- Age 18-40 years (inclusive of threshold), gender is not limited.
- Subjects have an Investigator's Global Assessment (IGA) score of 3 or 4 (i.e., moderate or severe).
- Men of childbearing potential and women of childbearing potential willing to use effective contraception from the time of signing the informed consent until 3 months after the last dose of the investigational drug; women of childbearing potential include premenopausal women and women within 2 years of menopause. Women of childbearing potential must have a negative pregnancy test result within ≤ 7 days prior to the first dose of the investigational drug.
- Subjects are willing and able to complete the study, are able to understand and comply with the study requirements, adhere to the study required restrictions and related tutorials, use the investigational drug as prescribed, and are followed up according to the study plan.
Exclusion
- Known hypersensitivity to the ingredients of ASC40 (Denifanstat) tablets or to any of the excipients.
- Presence of cystic acne at screening.
- Patients with secondary acne such as occupational acne (e.g., chloracne) and corticosteroid-induced secondary acne (e.g., chloracne or drug-induced acne)
- Patients with other significant coexisting skin conditions that may affect the evaluation of facial acne efficacy or require co-treatment, such as solardermatitis, psoriasis, seborrheic dermatitis, rosacea, folliculitis, eczema, etc..
- Thicker facial hair, which has been assessed by researchers to impede accurate assessment of acne vulgaris grades or lesion counts
Key Trial Info
Start Date :
January 23 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 19 2025
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT06192264
Start Date
January 23 2024
End Date
May 19 2025
Last Update
June 19 2025
Active Locations (41)
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1
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, China
2
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
3
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China
4
The Second Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China