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 range18 Years – 40 Years

SexALL

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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;
✕. 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;
✕. 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;

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