ClinicalTrials.gg
RecruitingNCT07637032Updated Jun 9, 2026

Clinical Study of a Facial Cream for Rosacea

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

From the registry’s dates

  • Primary completion was expected by Jul 2026, 4 months ago, but the record still lists the study as recruiting.
  • Started Apr 2026; still recruiting 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Facial Rosacea

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03

In context

Rosacea

233 studies on the registry are indexed under Rosacea; 23 are open to participants now.

This study's planned enrollment of 76 is above the median of 61 across 200 interventional studies indexed under Rosacea.

Browse Rosacea studies →

Lead sponsor

ChinaNorm is the lead sponsor of 30 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

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 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 (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 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.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
76 participants (estimated)

Study arms

  • Experimental
    Arm 1

    Investigational test cream, designed to evaluate its soothing effect on skin.

    Other: ARM 1

  • Experimental
    Arm 2

    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

Interventions

  • OtherARM 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.

  • OtherARM 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.

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2026 (actual). Primary completion is estimated for Jul 2026, 2 months after the start.

Of 42 interventional studies with no phase under Rosacea, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 29. This study's planned 2 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 4, 2026
First posted
Jun 9, 2026
StartActual
Apr 28, 2026
Primary completionEst.
Jul 9, 2026
CompletionEst.
Jul 31, 2026
Last update
Jun 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07637032
Lead sponsor
ChinaNorm
Responsible party
Sponsor
First posted
Jun 9, 2026
Start date
Apr 28, 2026
Primary completion
Jul 9, 2026 (estimated)
Completion
Jul 31, 2026 (estimated)
Last update
Jun 9, 2026

Study contacts

Yanwen Jiang
Contact
jiangyanwen@china-norm.com
13501700841

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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