Clinical Study of a Facial Cream for Rosacea (NCT07637032) | Clinical Trial Compass
RecruitingNot Applicable
Clinical Study of a Facial Cream for Rosacea
China76 participantsStarted 2026-04-28
Plain-language summary
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.
Who can participate
Age range
20 Years – 50 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
.The participants voluntarily join the study, fully understand the trial content and are willing to sign the informed consent form and portrait use authorization.
.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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Dermatologist-Assessed Rosacea Severity
Timeframe: Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
2
Dermatologist assessment of persistent erythema
Timeframe: Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
3
Dermatologist assessment of Counting Inflammatory Lesions
Timeframe: Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
4
Clinical assessment of facial TRoSA telangiectasia counts in subjects by dermatologists
Timeframe: Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
5
Dermatologist assessment of product tolerability
Timeframe: Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
6
Self-assessment Questionnaire
Timeframe: Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
. 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.