Acne VulgarisPhase 2NCT05104125
Study to Evaluate the Safety and Efficacy of ASC40 in Subjects With Moderate to Severe Acne Vulgaris
A Phase 2 study testing ASC40 25mg, ASC40 50mg and ASC40 75mg in people with Acne Vulgaris, run by Ascletis Pharmaceuticals Co., Ltd. at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- ASC40 25mg, ASC40 50mg and ASC40 75mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 12 Jan 2022to 10 Apr 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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);
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, 200000
About this study
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.
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.
- Conditions
- Acne Vulgaris
- Being tested
- ASC40 25mg, ASC40 50mg, ASC40 75mg, Placebo
- Keywords
- Acne vulgaris, ASC40
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASC40 25mgDrug
25mg of ASC40 orally once daily for 12 weeks.
ASC40 50mgDrug
50mg of ASC40 orally once daily for 12 weeks.
ASC40 75mgDrug
75mg of ASC40 orally once daily for 12 weeks.
PlaceboDrug
Placebo orally once daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group 1 | Experimental | ASC40 25mg for 12 weeks Receives: Drug: ASC40 25mg |
| Experimental group 2 | Experimental | ASC40 50mg for 12 weeks Receives: Drug: ASC40 50mg |
| Experimental group 3 | Experimental | ASC40 75mg for 12 weeks Receives: Drug: ASC40 75mg |
| Placebo group | Placebo comparator | Placebo for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change of total lesion count compared with baseline and week 12.
Measured: Baseline to week 12
Ratio of subjects, whose IGA grades was decreased by ≥2 grades compared with baseline at week 12.
Measured: Baseline to week 12
Secondary outcomes (2)
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.
Measured: 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
Measured: Baseline to week 2, 4, 8 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start12 Jan 2022
- Primary completion10 Apr 2023
- Study completion10 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ascletis Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05104125
- Sponsor's protocol ID
- ASC40-202
- Status last verified
- May 2023
- First submitted
- 26 Oct 2021
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41186280
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05104125
- Acronym / sponsor ID
- ASC40-202
- Conditions
- Acne Vulgaris
- Keywords
- Acne vulgaris, ASC40
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Ascletis Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Jan 2022 (actual)
- Primary completion
- 10 Apr 2023 (actual)
- Study completion
- 10 Apr 2023 (actual)
- First posted
- 2 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experimental group 1 | Experimental | Drug: ASC40 25mgASC40 25mg for 12 weeks |
| Experimental group 2 | Experimental | Drug: ASC40 50mgASC40 50mg for 12 weeks |
| Experimental group 3 | Experimental | Drug: ASC40 75mgASC40 75mg for 12 weeks |
| Placebo group | Placebo comparator | Drug: PlaceboPlacebo for 12 weeks |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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 (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASC40 25mg25mg of ASC40 orally once daily for 12 weeks. | Drug | Experimental group 1 |
| ASC40 50mg50mg of ASC40 orally once daily for 12 weeks. | Drug | Experimental group 2 |
| ASC40 75mg75mg of ASC40 orally once daily for 12 weeks. | Drug | Experimental group 3 |
| PlaceboPlacebo orally once daily for 12 weeks. | Drug | Placebo group |
Primary outcome
Percentage change of total lesion count compared with baseline and week 12.
Time frame: Baseline to week 12
Ratio of subjects, whose IGA grades was decreased by ≥2 grades compared with baseline at week 12.
Time frame: Baseline to week 12
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Derived from this study: PubMed 41186280Chen 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.
Related trials for Acne Vulgaris
Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ASC40 25mg, ASC40 50mg and ASC40 75mg in people with Acne Vulgaris, run by Ascletis Pharmaceuticals Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change of total lesion count compared with baseline and week 12. (time frame: Baseline to week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05104125, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.