Not Yet RecruitingPhase 2

Safety, Efficacy and Pharmacokinetic Characteristics of KR230109 Cream in Facial Acne Vulgaris

180 participantsStarted 2026-01-10

Plain-language summary

This study will evaluate the safety, efficacy and pharmacokinetics of KR230109 cream compared with placebo in Patients (18-40 Years) with Acne vulgaris

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. Those known to be allergic to KR230109 or drugs with the same mechanism of action such as tazarotene, adapalene, or any of their components;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The percentage change from baseline in the count of non-inflammatory facial lesions

Timeframe: week 12

The percentage change from baseline in the count of inflammatory facial lesions

Timeframe: week 12

Trial details

NCT IDNCT07345390

SponsorJiangxi Kvvit Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-10-30

Contact for this trial

jianzhong zhang, Master

+86 18001315877 rmpkzc@163.com

View on ClinicalTrials.gov More Acne Vulgaris trials