💬In plain words
What the trial is, and whether it could suit you
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,
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
1. Female Chinese subjects aged 20 to 50 years with Fitzpatrick skin type III-IV;
2. In good general health, with no chronic diseases or illnesses under treatment;
3. 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:
1. 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.
2. Participants currently enrolled in another clinical trial, or who have participated in any other clinical trial within the preceding 3 months.
3. Participants who have received physical, chemical or cosmetic procedures within 3 months prior to study enrollment.
4. 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).
5. 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.
6. Participants with other dermatoses (atopic dermatitis, seborrheic dermatitis, eczema, etc.) or evaluative confounding skin conditions (birthmarks, scars, etc.) at the study site.
7. Participants presenting with symptoms of phymatous rosacea or ocular rosacea at the study site.
8. Participants with a history of allergic contact dermatitis induced by cleansers or moisturizers.
9. Participants with a history of allergy to the investigational product or its ingredients, or a history of severe allergic reactions.
10. 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.
11. Any other conditions that, in the investigator's opinion, make the individual unsuitable for study participation.
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