This is an observational clinical study to evaluate the efficacy of the CeraVe Skin Care product line in improving mild to severe facial acne. Primary Objective: To evaluate the efficacy of CeraVe Skincare products in improving mild to severe facial acne through clinical observation by dermatologists of skin conditions before and after the use of the test product kit during the course of acne medication, as well as to collect concurrent feedback on the quality of life of this population and their experience with and satisfaction with the test product. Secondary objectives: 1. To collect feedback on the experience, satisfaction and quality of life improvement of CeraVe products through subjective evaluation of the subjects after using the products, in order to gain a deeper understanding of the comprehensive performance of the products in actual application; 2. To verify the tolerance of CeraVe products through clinical evaluation of the facial skin condition before and after the use of the products by dermatologists; 3. To evaluate the effectiveness of CeraVe products in improving acne. CeraVe is a dermatologist's clinical assessment of facial skin conditions before and after use to verify the tolerability and safety of CeraVe's skin care products. The study is designed to enroll approximately 240 male and female study participants aged 13 years or older with mild to severe facial acne, with a minimum sample size of 200 subjects based on a 15% dropout rate during the trial period and a protocol violation rate of no more than 5%. Participants entering the study will be classified as having mild, moderate, or severe acne according to the Global Evaluation Acne Grading Scale (GEA) (mild-grade 1 or grade 2, moderate-grade 3, severe-grade 4 or higher), with a sample size of mild acne:moderate acne:severe acne of approximately 1:1:1. The study was conducted over an 8-week period with 3 visits. They were conducted at the baseline visit (T0), week 4 follow-up (T4w) and week 8 follow-up (T8w). The window period was ±1 day for the week 4 (T4w) visit and ±2 days for the week 8 (T8w) visit. The primary evaluation parameters included: clinical assessment and product tolerance assessment by the dermatologist, patient self-assessment and questionnaires.
Study Type
OBSERVATIONAL
Enrollment
240
Patients with GEA classification 1 will be assigned to use CeraVe Blemish Control Cleanser in combination with CeraVe Blemish Control Gel. Patients in GEA Class 2 will be assigned to use CeraVe Blemish Control Cleanser in combination with CeraVe Facial Moisturising Lotion in combination with topical medications. Patients with GEA classification 3 will be assigned to use CeraVe Foaming Facial Cleanser in combination with CeraVe Facial Moisturising Lotion in combination with topical medications. Patients with a GEA classification of 4 and above will be assigned to use CeraVe Hydrating Facial Cleanser in combination with CeraVe Moisturising Cream in conjunction with a commonly used sunscreen product in combination with an oral medication.
Changes in patients' GEA grading before and after use of the trial product kit
The Global Evaluation Acne Grading Scale (GEA) is a clinical tool used to assess the severity of acne. The following are the specifics and criteria of the GEA grading scale. A score of 0 indicates clean skin with no lesions and possible hyperpigmentation or erythema. A score of 1 indicates almost clean skin, almost no lesions, occasionally visible, scattered open or closed pimples, almost no papules. 2 indicates mildly recognizable, almost no papules. A score of 2 represents mildly recognizable acne involving no more than half of the face, with a few open or closed pimples, a few papules and pustules. A score of 3 represents moderate acne involving more than half of the face, with many open or closed pimples, numerous papules and pustules, and possibly a nodule. A score of 4 represents severe acne involving the entire face, with many open or closed pimples, numerous papules and pustules, and occasional nodules. A score of 5 represents highly inflammatory acne covering the entire face
Time frame: Baseline visit, week 4 visit, week 8 visit
The physician evaluates the subject's skin condition by filling out a scale
The doctor evaluates the subject's skin condition by completing a scale, which is rated on a scale of 0-4 (0=no symptoms, 4=very severe) and includes: sebum secretion, enlarged pores, dryness, flakiness, erythema, itchiness, burning, stinging.
Time frame: Baseline visit, week 4 visit, week 8 visit
Self-assessment questionnaires on quality of life completed by subjects
A self-assessment questionnaire of quality of life was completed by the subjects, using a scale of 1-4, (1=not at all, 4=strongly agree), which included whether the subject was bothered by acne, whether acne had an impact on the subject's daily life, socialization, and so on.
Time frame: Baseline visit, week 4 visit, week 8 visit
The physician assesses the subject's tolerance and satisfaction of the investigational product by completing a scale.
The physician assesses the subject's tolerance of the investigational product by completing a scale, a 0-4 rating scale (0=not applicable, 4=strongly agree), which includes: whether the subject is a better candidate for the investigational product than for other products; and whether the investigational product is helpful to the patient and whether they were satisfied with the study product.
Time frame: Week 4 visit, week 8 visit
Questionnaire for patients to assess their own tolerance and satisfaction with the study product
Patient Assessment of Their Tolerance and Satisfaction with the Study Product Questionnaire, a 0-4 scale questionnaire, (0=not applicable, 4=strongly agree), which included: whether they preferred the study product over other products; whether the study product helped acne, and whether they were satisfied with the study product
Time frame: Week 4 visit, week 8 visit
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