Study to Evaluate the Safety and Efficacy of ASC40 in Subjects With Moderate to Severe Acne Vulgaris

Acne Vulgaris Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05104125
• Other study ID #: ASC40-202
• Status: Completed
• Phase: Phase 2
• Start date: January 12, 2022
• Est. completion date: April 10, 2023

Study information

• Verified date: May 2023
• Source: Ascletis Pharmaceuticals Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: April 10, 2023
• Est. primary completion date: April 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• ASC40 25mg
25mg of ASC40 orally once daily for 12 weeks.
• ASC40 50mg
50mg of ASC40 orally once daily for 12 weeks.
• ASC40 75mg
75mg of ASC40 orally once daily for 12 weeks.
• Placebo
Placebo orally once daily for 12 weeks.

Locations

Country	Name	City	State
China	Huashan Hospital Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ascletis Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage change of total lesion count compared with baseline and week 12.		Baseline to week 12
Primary	Ratio of subjects, whose IGA grades was decreased by =2 grades compared with baseline at week 12.		Baseline to week 12
Secondary	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
Secondary	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		Baseline to week 2, 4, 8 and 12