Acne VulgarisPhase 2NCT07345390
Safety, Efficacy and Pharmacokinetic Characteristics of KR230109 Cream in Facial Acne Vulgaris
A Phase 2 study testing KR230109 cream 0.025% and KR230109 cream 0.05% in people with Acne Vulgaris, run by Jiangxi Kvvit Pharmaceutical Co., Ltd..
Trial summary
This study will evaluate the safety, efficacy and pharmacokinetics of KR230109 cream compared with placebo in Patients (18-40 Years) with Acne vulgaris Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- KR230109 cream 0.025% and KR230109 cream 0.05%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2026to 30 Nov 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 40 years old (as of the time of signing the informed consent form), regardless of gender;
- Patients clinically diagnosed with mild to moderate facial acne vulgaris (refer to the "Chinese Acne Treatment Guidelines" 2019 revised edition), and with an overall facial IGA (Investigator Global Assessment) score of 2 to 3 by the study doctor;
- Baseline requirements: For patients with mild to moderate acne, the count of facial inflammatory lesions (papules and/or pustules) should be >=10 and <=40; the count of non-inflammatory lesions (open and/or closed comedones) should be >=20 and <=60; no facial nodules should exist;
- Participants must be willing to use only non-acne-treating skin care products during the trial and comply with the precautions required by the protocol;
- Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign the written informed consent form, and be able to complete the entire trial process as required;
- From the time of signing the informed consent form to 3 months after the last administration, female participants of childbearing age or male participants whose partners are of childbearing age must agree and be able to take effective contraceptive measures, such as avoiding sexual activity or using reliable contraceptive methods like condoms or intrauterine devices.
Who cannot join
- Those known to be allergic to KR230109 or drugs with the same mechanism of action such as tazarotene, adapalene, or any of their components;
- Those with a history of any serious clinical systemic diseases or surgeries, such as diseases of the circulatory system, nervous system, hematological system, immune system, or mental system;
- Those with concurrent other obvious skin diseases at the affected area that may affect the clinical evaluation of the researchers or require concurrent treatment, such as solar dermatitis, psoriasis, seborrheic dermatitis, rosacea, eczema, severe acne, and extremely severe acne (such as conglobate acne, fulminant acne, etc.);
- Those with secondary acne, such as occupational acne and acne caused by corticosteroids;
- Those with facial skin or hair conditions that may interfere with clinical assessment (such as significant beards, sideburns, or mustaches);
- Those who plan to use any adjunctive therapies or concomitant treatments for acne during the trial;
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- Those who have used acne-specific functional skin care products within one week before the start of treatment;
- Those who have used topical retinoids, antibiotics, corticosteroids, or other topical acne treatments on the face within two weeks before the trial;
- Those who have taken oral retinoids, antibiotics, corticosteroids (including intramuscular or intralesional injections, except for stable use of inhaled, intranasal, or intraocular corticosteroids for the treatment of underlying diseases and without impact on acne treatment), spironolactone, or other acne medications within four weeks before the trial;
- Those who have undergone physical or chemical acne treatments within four weeks before the trial;
- Those who have participated in other clinical trials and used trial drugs or medical devices within 90 days before screening or plan to participate in other clinical trials during the trial;
- Those whose vital signs, physical examinations, laboratory tests (blood routine, urine routine, blood biochemistry), electrocardiograms, etc., are abnormal and have clinical significance as assessed by the researchers and may affect the evaluation of this trial;
- Those who are positive for hepatitis B surface antigen, hepatitis C antibody, syphilis-specific antibody, or human immunodeficiency virus antibody;
- Pregnant or lactating women or those with positive blood or urine pregnancy tests;
- Those who need prolonged or excessive exposure to sunlight, such as sunbathing;
- Those with a history of alcohol abuse or drug abuse;
- Those who, in the opinion of the researchers, have poor compliance, or have conditions that may interfere with the study outcome, or those who, in the opinion of the researchers, have any other conditions that make them unsuitable for participation in this clinical trial.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Double-blind, Placebo-parallel-controlled Phase Ⅱ Clinical Trial to Evaluate the Safety, Efficacy and Pharmacokinetic Characteristics of KR230109 in Patients With Acne Vulgaris
This study will evaluate the safety, efficacy and pharmacokinetics of KR230109 cream compared with placebo in Patients (18-40 Years) with Acne vulgaris
- Conditions
- Acne Vulgaris
- Being tested
- KR230109 cream 0.025%, KR230109 cream 0.05%, Placebo
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KR230109 cream 0.025%Drug
KR230109 cream 0.025% is indicated for the topical treatment of acne vulgaris in patients
KR230109 cream 0.05%Drug
KR230109 cream 0.05% is indicated for the topical treatment of acne vulgaris in patients
PlaceboDrug
Also called Vehicle cream
Vehicle cream manufactured to mimic look and feel of KR230109 Cream but without the active ingredient.
| Study group | Role | What they receive |
|---|---|---|
| KR230109 cream 0.025% | Experimental | Participants applied KR230109 cream once daily for 12 consecutive weeks. Receives: Drug: KR230109 cream 0.025% |
| KR230109 cream 0.05% | Experimental | Participants applied KR230109 cream once daily for 12 consecutive weeks. Receives: Drug: KR230109 cream 0.05% |
| placebo | Placebo comparator | Participants applied placebo once daily for 12 consecutive weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage change from baseline in the count of non-inflammatory facial lesions
The percentage change from baseline in the count of non-inflammatory facial lesions at Week 12 compared with placebo in each treatment group.
Measured: week 12
The percentage change from baseline in the count of inflammatory facial lesions
The percentage change from baseline in the count of inflammatory facial lesions at Week 12 compared with placebo in each treatment group.
Measured: week 12
Secondary outcomes (7)
The average percentage change from baseline in the counts of inflammatory and non-inflammatory skin lesions
The average percentage change from baseline in the counts of inflammatory and non-inflammatory skin lesions at weeks 2, 4, 8 of treatment compared with placebo for each treatment group.
Measured: week 2,4,8
The absolute change from baseline in the counts of inflammatory and non-inflammatory skin lesions
The absolute change from baseline in the counts of inflammatory and non-inflammatory skin lesions at weeks 2, 4, 8, 12 of treatment compared with placebo for each treatment group.
Measured: week 2,4,8,12
The average percentage change and absolute change from baseline in the total skin lesion count
The average percentage change and absolute change from baseline in the total skin lesion count at weeks 2, 4, 8, 12 of treatment compared with placebo for each treatment group.
Measured: week 2,4,8,12
The proportion of participants in each treatment group with at least a 2-point reduction in IGA score from baseline and an IGA score of 0 or 1
The proportion of participants in each treatment group with at least a 2-point reduction in IGA score from baseline and an IGA score of 0 or 1 at weeks 2, 4, 8, 12 of treatment compared with placebo.
Measured: week 2,4,8,12
Safety endpoints
Adverse events (AEs), local skin reactions (LSRs), physical examinations, vital signs, electrocardiograms (ECGs), and abnormal clinical laboratory tests (blood routine, blood biochemistry, urine routine).
Measured: from day 1 to week 12
Steady-state PK parameters of KR230109: Cmax,ss.
Steady-state PK parameters of KR230109: Cmax,ss.
Measured: week 4
Steady-state PK parameters of KR230109: AUC0-24h,ss, etc.
Steady-state PK parameters of KR230109: AUC0-24h,ss, etc.
Measured: weeks 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start10 Jan 2026 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangxi Kvvit Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07345390
- Sponsor's protocol ID
- KR230109-202503
- Status last verified
- Jan 2026
- First submitted
- 25 Dec 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Placebo-parallel-controlled Phase Ⅱ Clinical Trial to Evaluate the Safety, Efficacy and Pharmacokinetic Characteristics of KR230109 in Patients With Acne Vulgaris
- ClinicalTrials.gov ID
- NCT07345390
- Acronym / sponsor ID
- KR230109-202503
- Conditions
- Acne Vulgaris
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Jiangxi Kvvit Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Jan 2026 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 15 Jan 2026 (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 study will evaluate the safety, efficacy and pharmacokinetics of KR230109 cream compared with placebo in Patients (18-40 Years) with Acne vulgaris
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| KR230109 cream 0.025% | Experimental | Drug: KR230109 cream 0.025%Participants applied KR230109 cream once daily for 12 consecutive weeks. |
| KR230109 cream 0.05% | Experimental | Drug: KR230109 cream 0.05%Participants applied KR230109 cream once daily for 12 consecutive weeks. |
| placebo | Placebo comparator | Drug: PlaceboParticipants applied placebo once daily for 12 consecutive weeks. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age between 18 and 40 years old (as of the time of signing the informed consent form), regardless of gender;
- Patients clinically diagnosed with mild to moderate facial acne vulgaris (refer to the "Chinese Acne Treatment Guidelines" 2019 revised edition), and with an overall facial IGA (Investigator Global Assessment) score of 2 to 3 by the study doctor;
- Baseline requirements: For patients with mild to moderate acne, the count of facial inflammatory lesions (papules and/or pustules) should be >=10 and <=40; the count of non-inflammatory lesions (open and/or closed comedones) should be >=20 and <=60; no facial nodules should exist;
- Participants must be willing to use only non-acne-treating skin care products during the trial and comply with the precautions required by the protocol;
- Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign the written informed consent form, and be able to complete the entire trial process as required;
Key exclusion criteria (17 listed)
- Those known to be allergic to KR230109 or drugs with the same mechanism of action such as tazarotene, adapalene, or any of their components;
- Those with a history of any serious clinical systemic diseases or surgeries, such as diseases of the circulatory system, nervous system, hematological system, immune system, or mental system;
- Those with concurrent other obvious skin diseases at the affected area that may affect the clinical evaluation of the researchers or require concurrent treatment, such as solar dermatitis, psoriasis, seborrheic dermatitis, rosacea, eczema, severe acne, and extremely severe acne (such as conglobate acne, fulminant acne, etc.);
- Those with secondary acne, such as occupational acne and acne caused by corticosteroids;
- Those with facial skin or hair conditions that may interfere with clinical assessment (such as significant beards, sideburns, or mustaches);
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 |
|---|---|---|
| KR230109 cream 0.025%KR230109 cream 0.025% is indicated for the topical treatment of acne vulgaris in patients | Drug | KR230109 cream 0.025% |
| KR230109 cream 0.05%KR230109 cream 0.05% is indicated for the topical treatment of acne vulgaris in patients | Drug | KR230109 cream 0.05% |
| PlaceboAlso: Vehicle creamVehicle cream manufactured to mimic look and feel of KR230109 Cream but without the active ingredient. | Drug | placebo |
Primary outcome
The percentage change from baseline in the count of non-inflammatory facial lesions
Time frame: week 12
The percentage change from baseline in the count of non-inflammatory facial lesions at Week 12 compared with placebo in each treatment group.
The percentage change from baseline in the count of inflammatory facial lesions
Time frame: week 12
The percentage change from baseline in the count of inflammatory facial lesions at Week 12 compared with placebo in each treatment group.
7 secondary outcomes
The average percentage change from baseline in the counts of inflammatory and non-inflammatory skin lesions
Time frame: week 2,4,8
The absolute change from baseline in the counts of inflammatory and non-inflammatory skin lesions
Time frame: week 2,4,8,12
The average percentage change and absolute change from baseline in the total skin lesion count
Time frame: week 2,4,8,12
The proportion of participants in each treatment group with at least a 2-point reduction in IGA score from baseline and an IGA score of 0 or 1
Time frame: week 2,4,8,12
Safety endpoints
Time frame: from day 1 to week 12
Steady-state PK parameters of KR230109: Cmax,ss.
Time frame: week 4
Steady-state PK parameters of KR230109: AUC0-24h,ss, etc.
Time frame: weeks 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KR230109 cream 0.025% and KR230109 cream 0.05% in people with Acne Vulgaris, run by Jiangxi Kvvit Pharmaceutical Co., Ltd..
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 6 inclusion and 17 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: opening soon, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact jianzhong zhang, Master (+86 18001315877, rmpkzc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage change from baseline in the count of non-inflammatory facial lesions (time frame: 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?
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 15 Jan 2026.