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An Observational Clinical Study to Evaluate the Efficacy of the CeraVe Skin Care Line

NCT ID: NCT07044024

Last Updated: 2025-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-27

Study Completion Date

2025-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acne

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with GEA Class 1

Patients with GEA Classification 1 will be assigned to use CeraVe Blemish Control Cleanser in combination with CeraVe Blemish Control Gel.

CeraVe

Intervention Type COMBINATION_PRODUCT

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.

Patients with GEA Class 2

Patients with GEA Classification 2 will be assigned to use CeraVe Blemish Control Cleanser in combination with CeraVe Facial Moisturising Lotion and topical medicine.

CeraVe

Intervention Type COMBINATION_PRODUCT

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.

Patients with GEA Class 3

Patients with GEA Classification 3 will be assigned to use CeraVe Foaming Facial Cleanser in combination with CeraVe Facial Moisturising Lotion and topical medicine.

CeraVe

Intervention Type COMBINATION_PRODUCT

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.

Patients with GEA Class 4 or above

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 combination with commonly used sunscreen products in combination with oral medications.

CeraVe

Intervention Type COMBINATION_PRODUCT

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.

Interventions

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CeraVe

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.

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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Topical acne medications Oral medications for acne

Eligibility Criteria

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Inclusion Criteria

* Chinese males and females, age eligible greater than or equal to 13 years old;
* Be in good health and free from any other chronic disease or disease under treatment;
* Be judged by a dermatologist at the Baseline visit:

Mild, moderate, or severe acne according to the Global Evaluation Acne Grading Scale (GEA)11,12 (Mild - Grade 1 or Grade 2) Acne Grading Scale (GEA) - Scale 1 or 2, Moderate - Scale 3, Severe - Scale 4 or above);

* Initiation of acne treatment within the last 3 months with medications that include, but are not limited to, the following

1. Topical medications: benzoyl peroxide (BPO), retinoic acid, adapalene, isotretinoin, azelaic acid, 0.1% adapalene/BPO. b) Topical medications: benzoyl peroxide (BPO), retinoic acid, adapalene, isotretinoin, azelaic acid, adapalene 0.3% adapalene/BPO, retinoic acid/clindamycin, BPO/clindamycin;
2. Oral medications: antibiotics, spironolactone, isotretinoin, etc; If Global Evaluation Acne Grading Scale (GEA) classification is ≥2, continuous use of the above medications for at least 2 weeks prior to the baseline visit is required.

If the Global Evaluation Acne Grading Scale (GEA) is ≥2, acne treatment with the above medications should be continued for at least 2 weeks before the baseline visit; If oral medication is used, acne treatment should be continued for at least 4 weeks prior to the baseline visit.

Exclusion Criteria

* Adult female study participants who intend to plan a pregnancy, or who are pregnant, breastfeeding, within 6 months of delivery, or who are unwilling to take the necessary precautions to avoid pregnancy;
* Study participants who are currently enrolled in another clinical study or have been enrolled in another clinical study within 3 months;
* Study participants who have undergone physical, chemical, or cosmetic surgery within 3 months prior to enrollment;
* Systemic diseases with severe organ damage, cardiovascular diseases, liver or kidney dysfunction, malignant tumors, chronic diseases with unstable control, acute infectious diseases, major surgeries or traumas, psychological and psychiatric disorders, or other diseases that require topical or systemic use of medications or treatments that have an effect on acne;
* The study site is associated with other skin disorders (atopic dermatitis, rosacea, rosacea, eczema, etc.) or the presence of other skin conditions that interfere with evaluation (birthmarks, scarring, etc.);
* Participants in the study have a history of allergic contact dermatitis caused by cleansers (facial cleansers)/moisturizers;
* History of allergy or severe allergy to the products (Sensitive Skin products) and related ingredients provided in the study;
* Study participants who are unable to follow compliance requirements, or who are known to be unable to attend visits on time, or who are unwilling to comply with the study protocol arrangements for the duration of the study;
* Any clinical presentation or other illness in the required observation area that, in the opinion of the investigator, may affect the study product assessment or results.
* Study participants had received medical aesthetic treatments (including but not limited to photofacial type treatments, fruit acid resurfacing, etc.) within 3 months prior to enrollment.
Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ChinaNorm

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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C25005055

Identifier Type: -

Identifier Source: org_study_id