Facial RosaceaNCT07637032
Clinical Study of a Facial Cream for Rosacea
A study testing ARM 1 and ARM 2 in people with Facial Rosacea, run by ChinaNorm at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Facial Rosacea
- What is being tested?
- ARM 1 and ARM 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 28 Apr 2026to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai China-norm Quality Technical Service Co., Ltd., Shanghai, Shanghai 200072, Shanghai,
Shanghai
Yanwen Jiang, +86 13501700841, jiangyanwen@china-norm.com
About this study
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.
- Conditions
- Facial Rosacea
- Being tested
- ARM 1, ARM 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARM 1Other
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 2Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Investigational test cream, designed to evaluate its soothing effect on skin. Receives: Other: ARM 1 |
| Arm 2 | Experimental | Subjects' own non-soothing daily facial cream, used as a negative control. No study-specific active intervention is provided in this arm. Receives: Other: ARM 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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).
Measured: Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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).
Measured: 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
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).
Measured: Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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).
Measured: Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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).
Measured: Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
Secondary outcomes (4)
Change in Skin Hydration Measured by Corneometer
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start28 Apr 2026
- Primary completion9 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial RosaceaStudies of the same condition, open and under way.
- More trials run by ChinaNormThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ChinaNorm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07637032
- Sponsor's protocol ID
- C26036010
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of a Facial Cream for Rosacea
- ClinicalTrials.gov ID
- NCT07637032
- Acronym / sponsor ID
- C26036010
- Conditions
- Facial Rosacea
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- ChinaNormIndustry (pharma, biotech, devices)
- Study start
- 28 Apr 2026 (actual)
- Primary completion
- 9 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Other: ARM 1Investigational test cream, designed to evaluate its soothing effect on skin. |
| Arm 2 | Experimental | Other: ARM 2Subjects' own non-soothing daily facial cream, used as a negative control. No study-specific active intervention is provided in this arm. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARM 1Morning/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 1 |
| ARM 2Morning/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. | Other | Arm 2 |
Primary outcome
Dermatologist-Assessed Rosacea Severity
Time frame: Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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).
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
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).
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
Dermatologists will count facial papules and pustules of study participants at T0 (baseline), T2w (2 weeks), T4w (4 weeks) and T8w (8 weeks).
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
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).
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
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).
Self-assessment Questionnaire
Time frame: Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8
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).
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ARM 1 and ARM 2 in people with Facial Rosacea, run by ChinaNorm at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yanwen Jiang (13501700841, jiangyanwen@china-norm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dermatologist-Assessed Rosacea Severity (time frame: Compared with baseline, Time point at Week 2, Time point at Week 4, Time point at Week 8). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.