Clinical Study of a Facial Cream for Rosacea

ConditionFacial Rosacea

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age20-50

SponsorChinaNorm

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

ARM 1
Other intervention
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.
ARM 2
Other intervention
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.

Treatment groups

76 Participants

are divided into 2 treatment groups

Group A: Arm 1Experimental treatment 1 intervention

Group B: Arm 2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

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