A Study to Evaluate the Safety and Efficacy of ASC40 (Denifanstat) Tablets in the Treatment of Patients With Moderate to Severe Acne Vulgaris
NCT ID: NCT06192264
Last Updated: 2025-06-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
480 participants
INTERVENTIONAL
2024-01-23
2025-05-19
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
There will be a total of 6 visits for screening and follow-up. The tests required by the program included routine blood tests, blood biochemistry, lipid profile, pregnancy test and urine routine, etc..
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Evaluate Safety of ASC40 Tablets in Patients With Moderate to Severe Acne Vulgaris
NCT06248008
Study to Evaluate the Safety and Efficacy of ASC40 in Subjects With Moderate to Severe Acne Vulgaris
NCT05104125
Efficacy and Safety of CD5024 1% in Acne Vulgaris
NCT03034460
A Efficacy and Safety of Duac™Compared With Clindamycin Phosphate Gel in the Treatment of Mild to Moderate Acne Vulgaris
NCT01915732
Placebo Controlled Efficacy and Safety Study of CD2475/101 40 mg Tablets vs. Placebo and Doxycycline 100 mg Capsules Once Daily in the Treatment of Inflammatory Lesions of Acne Vulgaris
NCT01320033
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ASC40 dose 1
ASC40 dose 1 84 days of treatment
ASC40
ASC 40 tablets orally once daily
ASC40 Placebo
ASC40 Placebo 84 days of treatment
ASC40
ASC 40 tablets orally once daily
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ASC40
ASC 40 tablets orally once daily
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 Criteria
* 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
18 Years
40 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ascletis Pharmaceuticals Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, China
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China
The Second Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China
Beijing Tsinghua Changgeng Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
The Fifth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Shenzhen Hospital, The University of Hong Kong
Shenzhen, Guangdong, China
The Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, China
Guilin Medical College Affiliated Hospital
Guilin, Guangxi, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangzhou, China
Shenzhen People's Hospital
Shenzhen, Guangzhou, China
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Nanyang First People's Hospital
Nanyang, Henan, China
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Wuhan Central Hospital
Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Changzhou First People's Hospital
Changzhou, Jiangsu, China
Lianyungang First People's Hospital
Lianyungang, Jiangsu, China
The First Affiliated Hospital of Gannan Medical College
Ganzhou, Jiangxi, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital of Xi'an Medical College
Xi’an, Shanxi, China
The Second Affiliated Hospital of Xi'an Jiaotong University School of Medicine
Xi’an, Shanxi, China
Chengdu Second People's Hospital
Chengdu, Sichuan, China
Suining Central Hospital
Suining, Sichuan, China
Tianjin Medical University General Hospital
Tianjing, Tianjing, China
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
Hangzhou Third People's Hospital
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Ningbo Second Hospital
Ningbo, Zhejiang, China
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Yiwu, Zhejiang, China
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ASC40-303
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.