Moderate to Severe Acne Vulgaris
Conditions
Interventions
Placebo group:ASC40 tablets placebo
Test group:ASC40 (dinifastat) tablets 50 mg dose
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-40 years (inclusive of threshold), gender is not limited. 2. Subjects have an Investigator's Global Assessment (IGA) score of 3 or 4 (i.e., moderate or severe). 3. The count of facial skin lesions in the subjects should meet the following criteria: 30 = inflammatory skin lesions <= 75, 30 <= non-inflammatory skin lesions <= 100; and the total count of nodules should be <= 2. 4. Men of childbearing age and women of childbearing age are willing to take effective contraceptive measures from the time of signing the informed consent form until three months after the last administration of the investigational drug. Women of childbearing age include premenopausal women and those within two years after menopause. The pregnancy test result of women of childbearing age within <=7 days before the first administration of the trial drug must be negative. 5. 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
Exclusion criteria: 1. Known hypersensitivity to the ingredients of ASC40 (Denifanstat) tablets or to any of the excipients. 2. Presence of cystic acne at screening. 3. Patients with secondary acne such as occupational acne (e.g., chloracne) and corticosteroid-induced secondary acne (e.g., chloracne or druginduced acne); 4. 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.. 5. Thicker facial hair, which has been assessed by researchers to impede accurate assessment of acne vulgaris grades or lesion counts; 6. Pre-existing or current inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease, pseudomembranous colitis, chronic diarrhea, or a history of antibiotic-related colitis, bloody diarrhea, etc.); 7. Previously diagnosed as polycystic ovary syndrome (PCOS); 8. There is a previous history of palm-soles redness, swelling and pain syndrome; 9. In the past, the skin was dry due to diseases such as ichthyosis and atopic dermatitis; 10. There is a previous history of hair loss treatment or a family history of hair loss; 11. Severe dry eye syndrome or other serious eye diseases, assessed as unsuitable for inclusion in the group; Or disagree not to wear contact lenses from baseline to the last administration; 12. There is a history of any serious clinical systemic diseases/surgical history, such as digestive system, circulatory system, nervous system, blood system, immune system, mental system diseases, etc; 13. Serum AST and ALT levels are >=3 times the upper limit of the normal range (ULN), and creatinine (Cr) exceeds the upper limit of the normal range; 14. Two weeks before the start of the treatment, the subjects used functional skin care products for acne (such as Yuze - Acne Care and Soothing Spray, Zilai Xi - Aloe Vera Acne Repair Gel, HFP Acne Whitening and Cleansing Set or HFP-HomeFacial Oligopeptide Serum, Manting - Qingman Revitalizing Acne and Oil Control Cleansing Cream, Lao Shen Yi - Acne Essence) Zhixuantang - Herbal Acne-Prone Skin Repair, Laroche Posay/ La Roche-Posay - Acne-Clearing Lotion Set); 15. Have used any of the following topical anti-acne treatments (topical anti-acne treatments, including but not limited to over-the-counter acne cleansers or treatments) : (1) Used within 2 weeks prior to the start of the treatment: Benzoyl peroxide, antibiotics (such as erythromycin, lincomycin, clindamycin, etc.), azelaic acid, sulfonamide products, corticosteroids and salicylic acid; (2) Used within 4 weeks before the start of treatment: retinoids, including tazarotin, adapalin, and retinoic acid; (3) Within 4 weeks before the start of treatment: Phototherapy, dermabrasion or chemical peeling has been carried out. 16. Any of the following systemic anti-acne treatments has been used: (1) Corticosteroid treatment (including intramuscular injection) was used within 4 weeks before the start of the treatment. Stable use of intranasal or ocular corticosteroids (defined as maintaining the dosage and frequency unchanged for at least 4 weeks before initiating treatment, except for inhaled steroid drugs that treat underlying diseases and have no effect on acne treatment); (2) Antibiotics (doxycycline, minocycline, erythromycin, roxithromycin, azithromycin) have been used within 4 weeks before the start of treatment (except for continuous use not exceeding 5 days), o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Investigator-assessed (IGA) percentage of treatment success;Percentage change from baseline in total lesion count;;Percentage change from baseline in inflammatory lesion count.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage change from baseline in noninflammatory skin lesion counts;Absolute change from baseline in total skin lesion count;Absolute change from baseline in inflammatory lesion count; | — |
Countries
China
Contacts
Public ContactLeihong Xiang
Huashan Hospital, Fudan University
Outcome results
None listed