Clinical Study of a Facial Cream for Rosacea

Overview

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.

Interventions

• Other ARM 1
  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.
• 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 participants' usual non-soothing facial cream (per their regular daily usage) to the entire face and gently massage until absorbed.

Primary outcome measures

• Dermatologist-Assessed Rosacea Severity [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 [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 [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 [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 [Time frame: Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8]
• Self-assessment Questionnaire [Time frame: Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8]

Secondary outcome measures (4)

• 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]

Eligibility criteria

Inclusion criteria

• Female Chinese subjects aged 20 to 50 years with Fitzpatrick skin type III-IV;
• In good general health, with no chronic diseases or illnesses under treatment;
• Assessed by a dermatologist at the baseline visit:

（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

• Female participants who are planning to become pregnant, are pregnant or breastfeeding, are within 6 months post-delivery, or refuse to take adequate contraceptive precautions.
• Participants currently enrolled in another clinical trial, or who have participated in any other clinical trial within the preceding 3 months.
• Participants who have received physical, chemical or cosmetic procedures within 3 months prior to study enrollment.
• Participants who have used any medications for rosacea within 4 weeks prior to enrollment, including topical preparations (metronidazole, azelaic acid, erythromycin ointment, etc.), oral agents (minocycline, doxycycline, oral isotretinoin, etc.) or corticosteroids (e.g., hydrocortisone).
• Participants with systemic diseases complicated by severe organ damage, cardiovascular diseases, hepatic or renal dysfunction, malignant tumors, poorly controlled chronic diseases, acute infectious diseases, major surgery or trauma, psychiatric disorders; or those requiring topical or systemic medications/treatments that may affect atopic dermatitis for other medical conditions.
• Participants with other dermatoses (atopic dermatitis, seborrheic dermatitis, eczema, etc.) or evaluative confounding skin conditions (birthmarks, scars, etc.) at the study site.
• Participants presenting with symptoms of phymatous rosacea or ocular rosacea at the study site.
• Participants with a history of allergic contact dermatitis induced by cleansers or moisturizers.
• Participants with a history of allergy to the investigational product or its ingredients, or a history of severe allergic reactions.
• Participants who fail to meet compliance requirements, are unable to attend scheduled visits on time, or are unwilling to abide by the study protocol throughout the trial.
• Any other conditions that, in the investigator's opinion, make the individual unsuitable for study participation.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

China · 1 center

• Shanghai China-norm Quality Technical Service Co., Ltd., Shanghai, Shanghai 200072, Shangh — Shanghai

Identifiers

NCT: NCT07637032 · C26036010

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗