Back to resultsStudy to Evaluate the Safety and Efficacy of ASC40 in Subjects With Moderate to Severe Acne Vulgaris
Primary Purpose
Acne Vulgaris
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
ASC40 25mg
ASC40 50mg
ASC40 75mg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris focused on measuring Acne vulgaris, ASC40
Eligibility Criteria
Key Inclusion Criteria:
- 18-40 years old (including 18 and 40 years old);
- Investigator's Global Assessment of subject at baseline period was at 3-4.
- Facial skin lesions of subject need counting as follows: 30 ~ 75 inflammatory lesions (the total number of papules, pustules and nodules is 30 ~ 75, including no more than 2 nodules), 30 ~ 100 non-inflammatory lesions (the total number of open and closed comedones is 30 ~ 100);
Key Exclusion Criteria:
- Known to be allergic or hypersensitive to ASC40 tablets;
- Facial nodules of subject is more than 2 facial nodules
- The subject with cystic acne
- Subject with secondary acne such as occupational acne (e.g., chloroacne) and acne caused by corticosteroids (e.g., chloroacne or acne caused by drugs);
- Serum AST, ALT≥3ULN and Cr exceeded the upper limit of normal range
Sites / Locations
- Huashan Hospital Fudan University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Experimental group 1
Experimental group 2
Experimental group 3
Placebo group
Arm Description
ASC40 25mg for 12 weeks
ASC40 50mg for 12 weeks
ASC40 75mg for 12 weeks
Placebo for 12 weeks
Outcomes
Primary Outcome Measures
Percentage change of total lesion count compared with baseline and week 12.
Ratio of subjects, whose IGA grades was decreased by ≥2 grades compared with baseline at week 12.
Secondary Outcome Measures
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.
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
Full Information
NCT ID
NCT05104125
First Posted
October 26, 2021
Last Updated
May 24, 2023
Sponsor
Ascletis Pharmaceuticals Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05104125
Brief Title
Study to Evaluate the Safety and Efficacy of ASC40 in Subjects With Moderate to Severe Acne Vulgaris
Official Title
A Phase II Randomized, Double-blind, Placebo-controlled, Multi-center, Multi-dose Study to Evaluate Safety and Efficacy of ASC40 Tablets in Subjects With Moderate to Severe Acne Vulgaris.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 12, 2022 (Actual)
Primary Completion Date
April 10, 2023 (Actual)
Study Completion Date
April 10, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ascletis Pharmaceuticals Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
Acne vulgaris, ASC40
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental group 1
Arm Type
Experimental
Arm Description
ASC40 25mg for 12 weeks
Arm Title
Experimental group 2
Arm Type
Experimental
Arm Description
ASC40 50mg for 12 weeks
Arm Title
Experimental group 3
Arm Type
Experimental
Arm Description
ASC40 75mg for 12 weeks
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Placebo for 12 weeks
Intervention Type
Drug
Intervention Name(s)
ASC40 25mg
Intervention Description
25mg of ASC40 orally once daily for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
ASC40 50mg
Intervention Description
50mg of ASC40 orally once daily for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
ASC40 75mg
Intervention Description
75mg of ASC40 orally once daily for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo orally once daily for 12 weeks.
Primary Outcome Measure Information:
Title
Percentage change of total lesion count compared with baseline and week 12.
Time Frame
Baseline to week 12
Title
Ratio of subjects, whose IGA grades was decreased by ≥2 grades compared with baseline at week 12.
Time Frame
Baseline to week 12
Secondary Outcome Measure Information:
Title
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.
Time Frame
Baseline to week 2, 4, 8 and 12
Title
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
Time Frame
Baseline to week 2, 4, 8 and 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
18-40 years old (including 18 and 40 years old);
Investigator's Global Assessment of subject at baseline period was at 3-4.
Facial skin lesions of subject need counting as follows: 30 ~ 75 inflammatory lesions (the total number of papules, pustules and nodules is 30 ~ 75, including no more than 2 nodules), 30 ~ 100 non-inflammatory lesions (the total number of open and closed comedones is 30 ~ 100);
Key Exclusion Criteria:
Known to be allergic or hypersensitive to ASC40 tablets;
Facial nodules of subject is more than 2 facial nodules
The subject with cystic acne
Subject with secondary acne such as occupational acne (e.g., chloroacne) and acne caused by corticosteroids (e.g., chloroacne or acne caused by drugs);
Serum AST, ALT≥3ULN and Cr exceeded the upper limit of normal range
Facility Information:
Facility Name
Huashan Hospital Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
12. IPD Sharing Statement
Learn more about this trial
Study to Evaluate the Safety and Efficacy of ASC40 in Subjects With Moderate to Severe Acne Vulgaris
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