NCT07345390尚未招募2 期
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
Jiangxi Kvvit Pharmaceutical Co., Ltd.0 个研究点目标入组 180 人开始时间: 2026年1月10日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 180
- 主要终点
- The percentage change from baseline in the count of non-inflammatory facial lesions
研究概览
简要总结
This study will evaluate the safety, efficacy and pharmacokinetics of KR230109 cream compared with placebo in Patients (18-40 Years) with Acne vulgaris
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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;
- •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.
结局指标
主要结局
The percentage change from baseline in the count of non-inflammatory facial lesions
时间窗: 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
时间窗: week 12
The percentage change from baseline in the count of inflammatory facial lesions at Week 12 compared with placebo in each treatment group.
次要结局
- The average percentage change from baseline in the counts of inflammatory and non-inflammatory skin lesions(week 2,4,8)
- The absolute change from baseline in the counts of inflammatory and non-inflammatory skin lesions(week 2,4,8,12)
- The average percentage change and absolute change from baseline in the total skin lesion count(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(week 2,4,8,12)
- Safety endpoints(from day 1 to week 12)
- Steady-state PK parameters of KR230109: Cmax,ss.(week 4)
- Steady-state PK parameters of KR230109: AUC0-24h,ss, etc.(weeks 4)
研究者
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