Atopic Dermatitis of FaceNCT07022288
A Clinical Study Evaluating the Application of La Roche-Posay's New B5 Multi-Effect Soothing and Repairing Cream on Individuals With Facial Atopic Dermatitis
A study testing LA ROCHE-POSAY CICAPLAST BALM, Standard cream in people with Atopic Dermatitis of Face, run by ChinaNorm at 1 site in China.
Trial summary
This study plans to recruit 76 subjects in accordance with the above inclusion and exclusion criteria, with at least 60 subjects completing the study. The study period is 8 weeks, and the subjects need to visit the research center 4 times. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Atopic Dermatitis of Face
- What is being tested?
- LA ROCHE-POSAY CICAPLAST BALM, Standard cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2025to 31 Oct 2025
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Chinese males and females aged 18 to 65 years old (including 18 and 65 years old); 2) In good health, without any other chronic diseases or diseases under treatment; 3) Have received atopic dermatitis drug treatments, including but not limited to:
- Topical glucocorticoids (TSC), such as 0.05% fluticasone propionate cream, 0.1% mometasone furoate cream, 0.1% hydrocortisone butyrate cream, 0.1% triamcinolone acetonide cream, 0.25% hydrocortisone cream, 0.05% desonide cream/ointment, etc.;
- Topical calcineurin inhibitors (TCI), such as 1% pimecrolimus cream, 0.03%/0.1% tacrolimus ointment, etc.;
- Oral antihistamines, such as cetirizine hydrochloride tablets, loratadine tablets, ebastine tablets, azelastine hydrochloride tablets, etc.;
- Other topical medications, such as zinc oxide oil (paste), black bean distillate oil ointment, topical phosphodiesterase 4 (PDE-4) inhibitor ointment, physiological sodium chloride solution, and other wet dressing medications, etc.; 4) At the baseline visit (Baseline), as determined by a dermatologist:
- Meeting Yao's diagnostic criteria,
- Atopic dermatitis severity is mild (Investigator Global Assessment, IGA ≤ 2 points);
- The condition is in a stable phase and no longer requires topical drug treatment 5) At the baseline visit (Baseline), trans-epidermal water loss (TEWL) measurement value > 15g/m²/h 6) Voluntarily participate in the trial, understand and be willing to sign the informed consent form; 7) Willing to follow the study protocol to use the products provided by the study throughout the study period, not use other similar products, keep diaries, and attend regular follow-ups and other trial requirements.
Who cannot join
- 1) Study participants who plan to become pregnant, are pregnant, are breastfeeding, are within 6 months after childbirth, or are unwilling to take necessary precautions to avoid pregnancy; 2) Study participants with atopic dermatitis in an acute exacerbation phase; 3) Study participants currently participating in other clinical trials or who have participated in other clinical trials within the past 3 months; 4) Study participants who used functional moisturizers containing skin microecology-regulating ingredients within 1 week before enrollment; 5) Study participants who received physical, chemical, or cosmetic surgical treatments within 3 months before enrollment; 6) Study participants with systemic diseases (severe organ damage), malignant tumors, poorly controlled chronic diseases, acute infectious diseases, major surgeries or trauma, psychological or mental disorders, or who require local or systemic use of drugs/treatments affecting atopic dermatitis due to other diseases; 7) Study participants who experience explosive exacerbation of atopic dermatitis lesions after using the treatment regimen; 8) Study participants with other skin diseases (acne, rosacea, eczema, infections, tumors, etc.) at the study site or other skin conditions interfering with evaluation (birthmarks, scars, etc.); 9) Study participants with a habit of scratching or squeezing atopic dermatitis lesions; 10) Study participants with a history of allergy to the products and related ingredients provided in the study; 11) Study participants with poor compliance, known inability to attend visits on time, or unwillingness to follow the study protocol during the study period; 12) Other circumstances where the investigator deems it inappropriate for the participant to join the study.
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 Municipality, 200072
Danwei Chen, 15623206068, chendanwei@china-norm.com
About this study
Official title: A Clinical Study Evaluating the Application of La Roche-Posay's New B5 Multi-Effect Soothing and Repairing Cream on Individuals With Facial Atopic Dermatitis.
This study plans to recruit 76 subjects in accordance with the above inclusion and exclusion criteria, with at least 60 subjects completing the study. The study period is 8 weeks, and the subjects need to visit the research center 4 times. After the subjects are enrolled, they will be randomly divided into two groups, including the experimental product group and the control product group.
The physiological indicators of the skin were measured by objective instruments and compared with those of ordinary moisturizers without skin microecological regulation components to evaluate the repair promotion effect and improvement of La Roche-Posay's new B5 Multi-Effect Soothing and Repairing Cream on the affected areas of patients with mild atopic dermatitis on the
- Conditions
- Atopic Dermatitis of Face
- Being tested
- LA ROCHE-POSAY CICAPLAST BALM, Standard cream
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LA ROCHE-POSAY CICAPLAST BALM, Standard creamOther
After enrollment, the investigator will generate random serial numbers for grouping through simple randomization.
LA ROCHE-POSAY CICAPLAST BALM：8 weeks application It is a leave-on product. It should be applied to the face twice a day during the research period.
Standard cream:8 weeks application It is a leave-on product. It should be applied to the face twice a day during the research period.
| Study group | Role | What they receive |
|---|---|---|
| LA ROCHE-POSAY CICAPLAST BALM | Experimental | Products Application and Usage Instruction
Mode of application: 0 Day~8 weeks
Frequency:
the study participants should apply LA ROCHE-POSAY CICAPLAST BALM to the entire face twice daily (morning and evening), with each application ranging from 0.5 to 0.75 grams. Receives: Other: LA ROCHE-POSAY CICAPLAST BALM, Standard cream |
| standard cream | Active comparator | Products Application and Usage Instruction
Mode of application: 0 Day~8 weeks
Frequency:
the study participants should apply standard cream to the entire face twice daily (morning and evening), with each application ranging from 0.5 to 0.75 grams. Receives: Other: LA ROCHE-POSAY CICAPLAST BALM, Standard cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sebum secretion on the skin surface
Sebum secretion on the skin surface will be measured by Sebumeter® SM 815 by trained technician.
Measured: Baseline, Time point at 2Week, Time point at 4Week, Time point at 8Week.
TEWL on the skin surface
TEWL on the skin surface will be measured by Vapometer by trained technician.
Measured: Baseline, Time point immediate,Time point at 2Week, Time point at 4Week, Time point at 8Week.
Skin hydration on the skin surface
Skin hydration on the skin surface will be measured by Corneometer® CM 825 by trained technician.
Measured: Baseline, Time point immediate,Time point at 2Week, Time point at 4Week, Time point at 8Week.
The pH value of the skin surface
The pH value of the skin surface will be measured by Skin-pH Meter PH 905 by trained technician.
Measured: Baseline, Time point immediate,Time point at 2Week, Time point at 4Week, Time point at 8Week.
Standardized facial image acquisition by VISIA
Trained professionals will use the standard light source and polarized light source in Visia 7 to photograph the frontal, left, and right sides of the study participants' faces for facial image acquisition.
Measured: Baseline,Time point at 2Week, Time point at 4Week, Time point at 8Week.
The safety and tolerability judgment by dermatologists based on the assessment of interviewed symptoms and observed signs
During the study, dermatologists will assess the facial condition of study participants. At each visit, each participant will be asked: "Are you experiencing any discomfort now?" If the participant answers "yes", the specific type of discomfort (e.g., tightness, stinging, burning, itching, or any other discomfort) should be recorded, along with the intensity and location of the discomfort. Additionally, dermatologists must carefully document the exact location (e.g., left cheek, right cheek, periocular area, etc.) of observed signs (such as erythema, edema, dryness, desquamation, acne, or any other symptoms) during the examination.
Measured: Baseline,Time point at 2Week, Time point at 4Week, Time point at 8Week.
Secondary outcomes (7)
The diagnostic criteria for atopic dermatitis evaluated according to Yao's diagnostic criteria
Yao's diagnostic evaluation criteria scoring standards are as follows:
- Itching;
- Typical morphology and location (flexural dermatitis), or atypical morphology and location accompanied by dry skin;
- Chronic or chronic relapsing course.
The diagnosis of atopic dermatitis can be made if all three of the above criteria are met.
Measured: Baseline, Time point immediate,Time point at 2Week, Time point at 4Week, Time point at 8Week.
The IGA (Investigator Global Assessment) scoring conducted by the investigator
The investigator performs the IGA (Investigator Global Assessment) scoring on the facial condition of study participants.(0 = clear,5 = very severe)
Measured: Baseline,Time point at 2Week, Time point at 4Week, Time point at 8Week
The facial Eczema Area and Severity Index (F-EASI) scoring conducted by the investigator
The Facial Eczema Area and Severity Index (F-EASI) scores erythema (E), edema/induration/papulation (I), excoriation (EX), and lichenification (L) across the entire face, combined with the affected area.
Measured: Baseline,Time point at 2Week, Time point at 4Week, Time point at 8Week
The clinical scoring for facial erythema
The clinical scoring for facial erythema (Erythema) is evaluated by dermatologists using a 0-4 grading scale（0 = none, 4 = severe）.
Measured: Baseline,Time point at 2Week, Time point at 4Week, Time point at 8Week
Study participants perform visual analog scale (VAS) scoring
Study participants perform visual analog scale (VAS) scoring for facial Itch, skin tightness, burning, stinging, and pain.
The Visual Analog Scale (VAS) is a straight line with extreme values of facial discomfort at both ends. The leftmost end of the scale is "no discomfort" (score = 0 mm), and the rightmost end is "extreme discomfort" (the most severe degree imaginable) (score = 100 mm).
Measured: Baseline, Time point immediate,Time point at 2Week, Time point at 4Week, Time point at 8Week.
The Dermatology Life Quality Index (DLQI) questionnaire completed by study participants
Study participants fill in the Dermatology Life Quality Index (DLQI) questionnaire based on their actual quality of life.Use a 0-3 scoring scale (0 = none, 3 = very severe).
Measured: Baseline, Time point at 2Week, Time point at 4Week, Time point at 8Week.
Skin microbiota detection
Trained operators will sample the marked typical affected areas of atopic dermatitis in study participants for biological sample collection. Microbial samples will be collected using swabs.
Alpha/beta diversity：Based on next-generation sequencing (NGS) technology, 16S rRNA sequencing will be used to detect changes in skin bacterial species of interest from baseline to time point at 8week, including variations in species richness and diversity (alpha/beta diversity).
Measured: Baseline, Time point at 4Week , Time point at 8Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start20 Apr 2025
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis of FaceStudies 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
- Supportive care
- 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
- Investigators
- Ping Xu, Master, Principal investigator, Shanghai China-norm Quality Technical Service Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07022288
- Sponsor's protocol ID
- C25005013
- Status last verified
- May 2025
- First submitted
- 21 May 2025
- Last updated
- 15 Jun 2025
- 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 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Evaluating the Application of La Roche-Posay's New B5 Multi-Effect Soothing and Repairing Cream on Individuals With Facial Atopic Dermatitis.
- ClinicalTrials.gov ID
- NCT07022288
- Acronym / sponsor ID
- C25005013
- Conditions
- Atopic Dermatitis of Face
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- ChinaNormIndustry (pharma, biotech, devices)
- Study start
- 20 Apr 2025 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 15 Jun 2025 (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 plans to recruit 76 subjects in accordance with the above inclusion and exclusion criteria, with at least 60 subjects completing the study. The study period is 8 weeks, and the subjects need to visit the research center 4 times. After the subjects are enrolled, they will be randomly divided into two groups, including the experimental product group and the control product group.
The physiological indicators of the skin were measured by objective instruments and compared with those of ordinary moisturizers without skin microecological regulation components to evaluate the repair promotion effect and improvement of La Roche-Posay's new B5 Multi-Effect Soothing and Repairing Cream on the affected areas of patients with mild atopic dermatitis on the
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LA ROCHE-POSAY CICAPLAST BALM | Experimental | Other: LA ROCHE-POSAY CICAPLAST BALM, Standard creamProducts Application and Usage Instruction Mode of application: 0 Day~8 weeks Frequency: the study participants should apply LA ROCHE-POSAY CICAPLAST BALM to the entire face twice daily (morning and evening), with each application ranging from 0.5 to 0.75 grams. |
| standard cream | Active comparator | Other: LA ROCHE-POSAY CICAPLAST BALM, Standard creamProducts Application and Usage Instruction Mode of application: 0 Day~8 weeks Frequency: the study participants should apply standard cream to the entire face twice daily (morning and evening), with each application ranging from 0.5 to 0.75 grams. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1) Chinese males and females aged 18 to 65 years old (including 18 and 65 years old); 2) In good health, without any other chronic diseases or diseases under treatment; 3) Have received atopic dermatitis drug treatments, including but not limited to:
Key exclusion criteria (1 listed)
- 1) Study participants who plan to become pregnant, are pregnant, are breastfeeding, are within 6 months after childbirth, or are unwilling to take necessary precautions to avoid pregnancy; 2) Study participants with atopic dermatitis in an acute exacerbation phase; 3) Study participants currently participating in other clinical trials or who have participated in other clinical trials within the past 3 months; 4) Study participants who used functional moisturizers containing skin microecology-regulating ingredients within 1 week before enrollment; 5) Study participants who received physical, chemical, or cosmetic surgical treatments within 3 months before enrollment; 6) Study participants with systemic diseases (severe organ damage), malignant tumors, poorly controlled chronic diseases, acute infectious diseases, major surgeries or trauma, psychological or mental disorders, or who require local or systemic use of drugs/treatments affecting atopic dermatitis due to other diseases; 7) Study participants who experience explosive exacerbation of atopic dermatitis lesions after using the treatment regimen; 8) Study participants with other skin diseases (acne, rosacea, eczema, infections, tumors, etc.) at the study site or other skin conditions interfering with evaluation (birthmarks, scars, etc.); 9) Study participants with a habit of scratching or squeezing atopic dermatitis lesions; 10) Study participants with a history of allergy to the products and related ingredients provided in the study; 11) Study participants with poor compliance, known inability to attend visits on time, or unwillingness to follow the study protocol during the study period; 12) Other circumstances where the investigator deems it inappropriate for the participant to join the study.
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 |
|---|---|---|
| LA ROCHE-POSAY CICAPLAST BALM, Standard creamAfter enrollment, the investigator will generate random serial numbers for grouping through simple randomization. LA ROCHE-POSAY CICAPLAST BALM：8 weeks application It is a leave-on product. It should be applied to the face twice a day during the research period. Standard cream:8 weeks application It is a leave-on product. It should be applied to the face twice a day during the research period. | Other | LA ROCHE-POSAY CICAPLAST BALM, standard cream |
Primary outcome
Sebum secretion on the skin surface
Time frame: Baseline, Time point at 2Week, Time point at 4Week, Time point at 8Week.
Sebum secretion on the skin surface will be measured by Sebumeter® SM 815 by trained technician.
TEWL on the skin surface
Time frame: Baseline, Time point immediate,Time point at 2Week, Time point at 4Week, Time point at 8Week.
TEWL on the skin surface will be measured by Vapometer by trained technician.
Skin hydration on the skin surface
Time frame: Baseline, Time point immediate,Time point at 2Week, Time point at 4Week, Time point at 8Week.
Skin hydration on the skin surface will be measured by Corneometer® CM 825 by trained technician.
The pH value of the skin surface
Time frame: Baseline, Time point immediate,Time point at 2Week, Time point at 4Week, Time point at 8Week.
The pH value of the skin surface will be measured by Skin-pH Meter PH 905 by trained technician.
Standardized facial image acquisition by VISIA
Time frame: Baseline,Time point at 2Week, Time point at 4Week, Time point at 8Week.
Trained professionals will use the standard light source and polarized light source in Visia 7 to photograph the frontal, left, and right sides of the study participants' faces for facial image acquisition.
The safety and tolerability judgment by dermatologists based on the assessment of interviewed symptoms and observed signs
Time frame: Baseline,Time point at 2Week, Time point at 4Week, Time point at 8Week.
During the study, dermatologists will assess the facial condition of study participants. At each visit, each participant will be asked: "Are you experiencing any discomfort now?" If the participant answers "yes", the specific type of discomfort (e.g., tightness, stinging, burning, itching, or any other discomfort) should be recorded, along with the intensity and location of the discomfort. Additionally, dermatologists must carefully document the exact location (e.g., left cheek, right cheek, periocular area, etc.) of observed signs (such as erythema, edema, dryness, desquamation, acne, or any other symptoms) during the examination.
7 secondary outcomes
The diagnostic criteria for atopic dermatitis evaluated according to Yao's diagnostic criteria
Time frame: Baseline, Time point immediate,Time point at 2Week, Time point at 4Week, Time point at 8Week.
The IGA (Investigator Global Assessment) scoring conducted by the investigator
Time frame: Baseline,Time point at 2Week, Time point at 4Week, Time point at 8Week
The facial Eczema Area and Severity Index (F-EASI) scoring conducted by the investigator
Time frame: Baseline,Time point at 2Week, Time point at 4Week, Time point at 8Week
The clinical scoring for facial erythema
Time frame: Baseline,Time point at 2Week, Time point at 4Week, Time point at 8Week
Study participants perform visual analog scale (VAS) scoring
Time frame: Baseline, Time point immediate,Time point at 2Week, Time point at 4Week, Time point at 8Week.
The Dermatology Life Quality Index (DLQI) questionnaire completed by study participants
Time frame: Baseline, Time point at 2Week, Time point at 4Week, Time point at 8Week.
Skin microbiota detection
Time frame: Baseline, Time point at 4Week , Time point at 8Week
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 15 Jun 2025.
- 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.
Ping Xu, Master principal investigator
Shanghai China-norm Quality Technical Service Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LA ROCHE-POSAY CICAPLAST BALM, Standard cream in people with Atopic Dermatitis of Face, 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 8 inclusion and 1 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 15 Jun 2025. 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 Danwei Chen (15623206068, chendanwei@china-norm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sebum secretion on the skin surface (time frame: Baseline, Time point at 2Week, Time point at 4Week, Time point at 8Week.). 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 15 Jun 2025.