AcneNCT07044024
An Observational Clinical Study to Evaluate the Efficacy of the CeraVe Skin Care Line
An observational study of Acne, run by ChinaNorm.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Acne
- What is being tested?
- CeraVe
- Type of treatment
- Pill or oral medicine
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- 27 Jun 2025to 31 Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- Child, Adult, Older adult
Study population: Male or Female Study Participants Aged 13 Years or Older with Mild to Severe Acne on the Face
Who may be able to join
- 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
- 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;
- 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.
Who cannot join
- 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;
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- 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.
About this study
Official title: An Observational Clinical Study to Evaluate the Efficacy of the CeraVe Skin Care Line in Improving Mild to Severe Acne on the Face
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.
- Conditions
- Acne
- Being tested
- CeraVe
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CeraVeCombination product
Also called Topical acne medications, Oral medications for acne
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Combination Product: CeraVe | |
| 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. Receives: Combination Product: CeraVe | |
| 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. Receives: Combination Product: CeraVe | |
| 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. Receives: Combination Product: CeraVe |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: Baseline visit, week 4 visit, week 8 visit
Secondary outcomes (2)
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.
Measured: 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
Measured: Week 4 visit, week 8 visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start27 Jun 2025 (estimated)
- Primary completion14 Sep 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcneStudies of the same condition, open and under way.
- More trials run by ChinaNormThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ChinaNorm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07044024
- Sponsor's protocol ID
- C25005055
- Status last verified
- Jun 2025
- First submitted
- 15 Jun 2025
- Last updated
- 29 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Clinical Study to Evaluate the Efficacy of the CeraVe Skin Care Line in Improving Mild to Severe Acne on the Face
- ClinicalTrials.gov ID
- NCT07044024
- Acronym / sponsor ID
- C25005055
- Conditions
- Acne
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- ChinaNormIndustry (pharma, biotech, devices)
- Study start
- 27 Jun 2025 (estimated)
- Primary completion
- 14 Sep 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 29 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients with GEA Class 1 | – | Combination Product: CeraVePatients with GEA Classification 1 will be assigned to use CeraVe Blemish Control Cleanser in combination with CeraVe Blemish Control Gel. |
| Patients with GEA Class 2 | – | Combination Product: CeraVePatients with GEA Classification 2 will be assigned to use CeraVe Blemish Control Cleanser in combination with CeraVe Facial Moisturising Lotion and topical medicine. |
| Patients with GEA Class 3 | – | Combination Product: CeraVePatients with GEA Classification 3 will be assigned to use CeraVe Foaming Facial Cleanser in combination with CeraVe Facial Moisturising Lotion and topical medicine. |
| Patients with GEA Class 4 or above | – | Combination Product: CeraVePatients 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. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Male or Female Study Participants Aged 13 Years or Older with Mild to Severe Acne on the Face
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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.);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CeraVeAlso: Topical acne medications, Oral medications for acnePatients 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. | Combination product | Patients with GEA Class 1, Patients with GEA Class 2, Patients with GEA Class 3, Patients with GEA Class 4 or above |
Primary outcome
Changes in patients' GEA grading before and after use of the trial product kit
Time frame: Baseline visit, week 4 visit, week 8 visit
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
The physician evaluates the subject's skin condition by filling out a scale
Time frame: Baseline visit, week 4 visit, week 8 visit
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.
Self-assessment questionnaires on quality of life completed by subjects
Time frame: Baseline visit, week 4 visit, week 8 visit
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.
2 secondary outcomes
The physician assesses the subject's tolerance and satisfaction of the investigational product by completing a scale.
Time frame: Week 4 visit, week 8 visit
Questionnaire for patients to assess their own tolerance and satisfaction with the study product
Time frame: Week 4 visit, week 8 visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acne, run by ChinaNorm.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in patients' GEA grading before and after use of the trial product kit (time frame: Baseline visit, week 4 visit, week 8 visit). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.