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This is a phase2, randomized, double-blind, multi-center, multi-dose and placebo parallel controlled design. The subjects in the study group were given double-blind drugs, and they were taken (orally) after dinner every day according to the requirements of clinical trial scheme.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group 1 | Experimental | ASC40 25mg for 12 weeks |
|
| Experimental group 2 | Experimental | ASC40 50mg for 12 weeks |
|
| Experimental group 3 | Experimental | ASC40 75mg for 12 weeks |
|
| Placebo group | Placebo Comparator | Placebo for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASC40 25mg | Drug | 25mg of ASC40 orally once daily for 12 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change of total lesion count compared with baseline and week 12. | Baseline to week 12 | |
| Ratio of subjects, whose IGA grades was decreased by ≥2 grades compared with baseline at week 12. | Baseline to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| The changes status and changes of average percentage of inflammatory skin lesions count, non-inflammatory skin lesions count and total skin lesions count compared with baseline. | Baseline to week 2, 4, 8 and 12 | |
| Ratio of subjects, whose GA grades was 1 or 0, or GA grades was decreased y ≥2 grades compared with baseline and Improvements in classification |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital Fudan University | Shanghai | Shanghai Municipality | 200000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41186280 | Derived | Chen Q, Chen R, Wu L, Xu A, He L, Wang J, Lu Y, Xiao R, Liu L, Feng Y, Zhang C, Dai X, Gao Y, Yan Y, Wu JJ, Xiang L. Denifanstat for moderate-to-severe acne: A Phase 2, randomized, double-blind, placebo-controlled trial. J Eur Acad Dermatol Venereol. 2026 Jul;40(7):1238-1246. doi: 10.1111/jdv.70119. Epub 2025 Nov 4. |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ASC40 50mg |
| Drug |
50mg of ASC40 orally once daily for 12 weeks. |
|
| ASC40 75mg | Drug | 75mg of ASC40 orally once daily for 12 weeks. |
|
| Placebo | Drug | Placebo orally once daily for 12 weeks. |
|
| Baseline to week 2, 4, 8 and 12 |