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

ConditionAcne
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age13+
SponsorChinaNorm

About this trial

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.

Eligibility criteria

Qualifiers

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;

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • CeraVe

Treatment groups

240 Participants
are divided into 4 treatment groups

Locations

This trial has no locations

Sponsors and collaborators