An interventional study of ARM 1 and ARM 2 in Facial Rosacea, sponsored by ChinaNorm. Recruiting at 1 site in China. Open to female participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-09.
Sponsored by ChinaNorm · Not applicable, Interventional, and Other
This study aimed to evaluate the efficacy, tolerability, and safety of Eucerin Skin Relief Multi-Repair Cream containing the active ingredient SenSiCel™ in improving facial rosacea. A single-center, randomized, negative-controlled clinical intervention design was adopted. A total of 76 Chinese women aged 20-50 years with Fitzpatrick skin types III-IV and mild-to-moderate rosacea (IGA score 2-3, CEA score 2-3, ≤3 inflammatory papules/pustules) were enrolled. Subjects were randomized in a 1:1 ratio into the test group (using the investigational cream) and the control group (using non-soothing daily facial cream), with an 8-week intervention period and four visits scheduled at baseline, Week 2, Week 4, and Week 8. The primary endpoint was the change from baseline in the Investigator's Global Assessment (IGA) score at Week 8. Secondary endpoints included changes in persistent erythema score, inflammatory lesion count, skin hydration, transepidermal water loss, hemoglobin index, red area proportion, and results of subject self-assessment questionnaires (Likert scale, DLQI). Tolerability and safety were also evaluated via dermatologist assessments and subject feedback. Data were analyzed using descriptive statistics, paired t-test/Wilcoxon signed-rank test, and independent t-test/Wilcoxon rank-sum test. This study provides clinical evidence for a safe and gentle adjuvant skincare regimen for patients with rosacea and offers a reference for efficacy validation of skincare products containing active ingredients.
（1）Present with persistent mild erythema on the midface (cheeks, nose, chin and forehead), graded as mild to moderate with a score of 2-3 according to the Clinician's Erythema Assessment (CEA, 0-4 scale) for facial persistent erythema; （2）Graded as mild to moderate with a score of 2-3 based on the papule and pustule assessment scale, inflammatory lesion count and Investigator's Global Assessment (IGA, 0-4 scale); （3）5Have no more than 3 mild inflammatory papules/pustules on the face; Present with none or only very mild facial telangiectasia; （4）Have not changed daily skin care products in the past three months, and do not use soothing skin care products, medical devices or medical dressings. 4.No additional or replacement skin care products are permitted throughout the study period except the test product.
5.The participants voluntarily join the study, fully understand the trial content and are willing to sign the informed consent form and portrait use authorization.
6.During the entire study period, participants shall comply with the study protocol, use the products provided by the study, and refrain from using other similar products. They are also required to keep study diaries and attend regular follow-up visits as stipulated.
Exclusion Criteria:
Investigational test cream, designed to evaluate its soothing effect on skin.
Other: ARM 1
Subjects' own non-soothing daily facial cream, used as a negative control. No study-specific active intervention is provided in this arm.
Other: ARM 2
Morning/Evening: Study participants shall cleanse their entire face with water or facial cleanser. After the skin is dry, apply an appropriate amount of the investigational product cream (1-2 pumps per use) to the entire face and gently massage until absorbed.
Morning/Evening: Study participants shall cleanse their entire face with water or facial cleanser. After the skin is dry, apply an appropriate amount of the participants' usual non-soothing facial cream (per their regular daily usage) to the entire face and gently massage until absorbed.
Dermatologist-Assessed Rosacea Severity
Investigator's Global Assessment (IGA) is a clinical tool that can be used to evaluate the severity of rosacea. The severity of rosacea is assessed and determined using the IGA grading scale, with scores recorded at T0 (baseline), T2w (2 weeks), T4w (4 weeks), and T8w (8 weeks).
Time frame: Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
Dermatologist assessment of persistent erythema
The Persistent Erythema CEA Scale (0-4 points) is used to assess persistent erythema. Scoring will be performed at T0 (baseline), T2w (2 weeks), T4w (4 weeks) and T8w (8 weeks).
Time frame: Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
Dermatologist assessment of Counting Inflammatory Lesions
Dermatologists will count facial papules and pustules of study participants at T0 (baseline), T2w (2 weeks), T4w (4 weeks) and T8w (8 weeks).
Time frame: Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
Clinical assessment of facial TRoSA telangiectasia counts in subjects by dermatologists
Assessment of subjects' telangiectasia is conducted using the TRoSA Telangiectasia Scale (0-4 points). Scoring is performed at T0 (baseline), T2w (2 weeks), T4w (4 weeks) and T8w (8 weeks).
Time frame: Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
Dermatologist assessment of product tolerability
Dermatologists use the safety assessment scale (0-3 points) to evaluate symptoms including edema, papules, desquamation, stinging, pruritus and burning. Assessments are performed at T0 (baseline), T2w (2 weeks), T4w (4 weeks) and T8w (8 weeks).
Time frame: Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
Self-assessment Questionnaire
Study participants are required to complete the skin sensation self-assessment questionnaire (Likert scale) and the Dermatology Life Quality Index (DLQI) at T0 (baseline), T2w (2 weeks), T4w (4 weeks) and T8w (8 weeks).
Time frame: Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
Change in Skin Hydration Measured by Corneometer
Time frame: Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
Change in Transepidermal Water Loss (TEWL) measured by Tewameter® TM HEX (Courage + Khazaka, Germany)
Time frame: Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
Change in Hemoglobin Index measured by Mexameter® MX 18 (Courage + Khazaka, Germany)
Time frame: Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
Skin changes captured via VISIA-CR imaging (Canfield Scientific, Inc., USA)
Time frame: Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
Plan to share: No
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