This study will evaluate the safety, efficacy and pharmacokinetics of KR230109 cream compared with placebo in Patients (18-40 Years) with Acne vulgaris
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;
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;
Parallel
KR230109 cream 0.025%
DrugKR230109 cream 0.025% is indicated for the topical treatment of acne vulgaris in patients
KR230109 cream 0.05%
DrugKR230109 cream 0.05% is indicated for the topical treatment of acne vulgaris in patients
Placebo
DrugVehicle cream manufactured to mimic look and feel of KR230109 Cream but without the active ingredient.
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.
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.
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.
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.
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.
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.
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This trial is not recruiting at the moment. You can still explore other options:
