Skin Barrier FunctionNCT07896993
Mask Instant Clinical Study
A study testing Test soothing facial mask in people with Skin Barrier Function and Skin Soothing Effect, run by ChinaNorm at 1 site in China.
Trial summary
The goal of this clinical study is to evaluate the soothing effect of the test product within 2 hours after a single application by measuring changes in multiple indicators before and after product use. It will also assess the safety of the test product. Read more about this study
- Who is it for?
- Ages 25 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Barrier Function, Skin Soothing Effect
- What is being tested?
- Test soothing facial mask
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 12 Jun 2026to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Chinese female, 25-45 years old. 2. Self-declare mild sensitive skin. 3. Self-declare with skin concerns of redness and easy to flush. 4. Willing to be exposed to infrared light on the facial area to induce facial redness.
- 5. Presenting with corresponding severity for the attribute evaluated by Dermatologist included:
- ◼ Skin redness after infrared light induction (7-8 min): grade ≥4 (0-9 scale). 6. All accept not to use any cosmetics, skincare products, beauty equipment, and all topical medications on the face within 72 hours prior to the study and on the visit day before coming to the lab, except for a cleanser. 7. Did not participate in any clinical test or cosmetic product test on skin within 1 month.
- 8. No disagreement of dermatologist because of other reasons that exclude the participation of the volunteer. 9. In general, good health at the time of the study. 10. Willing and able to participate as evidenced by signing of informed consent and photo release form.
- 11. Must be willing to comply with all study protocol requirements.
Who cannot join
- 1. Pregnant or breast-feeding woman or woman planning pregnancy during the study.
- 2. Subject deprived of rights by a court or administrative order. 3. Major subject to a guardianship order. 4. Subject residing in a health or social care establishment. 5. Patient in an emergency setting. 6. Volunteer with a skin disease in the test areas as well as skin allergy (particularly e.g., acne, rosacea, eczema). 7. Volunteer presenting a stable or progressive serious disease (per investigator's assessment).
- 8. Immuno-compromised subject. 9. Subject with history of allergy to cosmetic or personal care products or ingredients.
- 10. Subject presenting excessive exposure to sunlight or UV radiation (investigator's assessment).
- 11. Subject with history of sunlight sensitivity or allergies. 12. Subjects regularly practicing aquatic or nautical sports. 13. Subjects regularly attending a sauna. 14. Subject with physical highly sensitive constitution. 15. Subject with cardiovascular or circulatory history. 16. Subject with a history of skin cancer or malignant melanoma. 17. Subject with history of medical beauty treatment and taking part in other studies in the last 6 months before study. 18.Use of antihistamines, antibiotics, corticosteroids, non-steroidal anti-inflammatory drugs (NSAIDs), or immunosuppressants within 6 months prior to the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai China-norm Quality Technical Service Co., Ltd., Shanghai, Shanghai 200072, Shanghai,
Shanghai, Shanghai Municipality
About this study
The goal of this clinical study is to evaluate the soothing effect of the test product within 2 hours after a single application by measuring changes in multiple indicators before and after product use. It will also assess the safety of the test product. The main questions it aims to answer are:
- Does the test product relieve skin irritation and reduce skin redness within 2 hours after single use?
- What adverse skin reactions do participants experience after using the test product?
Read more
Researchers will compare the treated half-face with the untreated contralateral half-face (split-face control) to verify the soothing efficacy of the test product.
Participants will:
- Receive skin redness induction on both cheeks, then apply the test product on one side of the face
- Undergo skin assessments at baseline before redness induction, post-induction, and at 10 seconds, 1 minute, 5 minutes, 10 minutes, 1 hour and 2 hours after product application
- Complete clinical evaluation, instrumental measurement, image analysis and self-assessment questionnaires at each time point
- Conditions
- Skin Barrier Function, Skin Soothing Effect
- Being tested
- Test soothing facial mask
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test soothing facial maskOther
Facial mask containing panthenol and madecassoside, applied on one hemiface for 15 minutes in single use after erythema induction.
| Study group | Role | What they receive |
|---|---|---|
| Arm A ：Test Facial Mask Side | Experimental | Test half-face treatment: after skin erythema induction, trained investigator applies half-piece test facial mask on randomly assigned hemiface, kept for 15 minutes then removed. Receives: Other: Test soothing facial mask |
| Arm B ：Control Side | No intervention | Control half-face treatment: after skin erythema induction, no mask or test product applied on the contralateral hemiface. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Erythema index measured by Mexameter MX18
Skin erythema index of the hemiface will be measured by Mexameter MX18. Three consecutive valid readings will be taken and averaged for each measurement.
Measured: BL (before infrared induction), T0 (immediately after induction), 10 minutes, 1 hour and 2 hours after induction
Secondary outcomes (4)
Dermatologist clinical assessment of skin redness
Dermatologists perform clinical assessment of skin redness using modified Griffiths 10-point scale (0-9, half-point increments allowed). Whenever possible, the same dermatologist assesses the same participant; the rater is not permitted to refer to previous scores for post-baseline evaluations.
Measured: BL (before infrared induction), T0 (immediately after induction), 10 minutes, 1 hour and 2 hours after induction
VISIA-CR facial photography
Standardized facial images (front, left, right) are captured under 4 lighting modes including standard light 1, standard light 2, cross polarized and parallel polarized light.
Measured: BL (before infrared induction), T0 (immediately after induction), 10 minutes, 1 hour and 2 hours after induction
TiVi700 measurement of skin microcirculation
TiVi700 captures skin microvascular red blood cell concentration (TiVi index) on bilateral cheek regions to assess cutaneous microcirculation status.
Measured: BL (before infrared induction), T0 (immediately after induction), 10 minutes, 1 hour and 2 hours after induction
Subject self-assessment questionnaire for skin sensory symptoms
Subjects self-grade stinging, itching, burning and tightness on a 0-4 intensity scale. Score 0 = none; Score 1 = very slight; Score 2 = slight; Score3 = moderate; Score4 = severe.
Measured: 10 minutes, 1 hour and 2 hours after infrared induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start12 Jun 2026
- Primary completion15 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Barrier FunctionStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- ChinaNorm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07896993
- Sponsor's protocol ID
- C26005061
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 27 Oct 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 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mask Instant Clinical Study
- ClinicalTrials.gov ID
- NCT07896993
- Acronym / sponsor ID
- C26005061
- Conditions
- Skin Barrier Function, Skin Soothing Effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- ChinaNormIndustry (pharma, biotech, devices)
- Study start
- 12 Jun 2026 (actual)
- Primary completion
- 15 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 27 Oct 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.
The goal of this clinical study is to evaluate the soothing effect of the test product within 2 hours after a single application by measuring changes in multiple indicators before and after product use. It will also assess the safety of the test product. The main questions it aims to answer are:
- Does the test product relieve skin irritation and reduce skin redness within 2 hours after single use?
- What adverse skin reactions do participants experience after using the test product?
Researchers will compare the treated half-face with the untreated contralateral half-face (split-face control) to verify the soothing efficacy of the test product.
Participants will:
- Receive skin redness induction on both cheeks, then apply the test product on one side of the face
- Undergo skin assessments at baseline before redness induction, post-induction, and at 10 seconds, 1 minute, 5 minutes, 10 minutes, 1 hour and 2 hours after product application
- Complete clinical evaluation, instrumental measurement, image analysis and self-assessment questionnaires at each time point
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A ：Test Facial Mask Side | Experimental | Other: Test soothing facial maskTest half-face treatment: after skin erythema induction, trained investigator applies half-piece test facial mask on randomly assigned hemiface, kept for 15 minutes then removed. |
| Arm B ：Control Side | No intervention | –Control half-face treatment: after skin erythema induction, no mask or test product applied on the contralateral hemiface. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 1. Chinese female, 25-45 years old. 2. Self-declare mild sensitive skin. 3. Self-declare with skin concerns of redness and easy to flush. 4. Willing to be exposed to infrared light on the facial area to induce facial redness.
- 5. Presenting with corresponding severity for the attribute evaluated by Dermatologist included:
- ◼ Skin redness after infrared light induction (7-8 min): grade ≥4 (0-9 scale). 6. All accept not to use any cosmetics, skincare products, beauty equipment, and all topical medications on the face within 72 hours prior to the study and on the visit day before coming to the lab, except for a cleanser. 7. Did not participate in any clinical test or cosmetic product test on skin within 1 month.
- 8. No disagreement of dermatologist because of other reasons that exclude the participation of the volunteer. 9. In general, good health at the time of the study. 10. Willing and able to participate as evidenced by signing of informed consent and photo release form.
- 11. Must be willing to comply with all study protocol requirements.
Key exclusion criteria (5 listed)
- 1. Pregnant or breast-feeding woman or woman planning pregnancy during the study.
- 2. Subject deprived of rights by a court or administrative order. 3. Major subject to a guardianship order. 4. Subject residing in a health or social care establishment. 5. Patient in an emergency setting. 6. Volunteer with a skin disease in the test areas as well as skin allergy (particularly e.g., acne, rosacea, eczema). 7. Volunteer presenting a stable or progressive serious disease (per investigator's assessment).
- 8. Immuno-compromised subject. 9. Subject with history of allergy to cosmetic or personal care products or ingredients.
- 10. Subject presenting excessive exposure to sunlight or UV radiation (investigator's assessment).
- 11. Subject with history of sunlight sensitivity or allergies. 12. Subjects regularly practicing aquatic or nautical sports. 13. Subjects regularly attending a sauna. 14. Subject with physical highly sensitive constitution. 15. Subject with cardiovascular or circulatory history. 16. Subject with a history of skin cancer or malignant melanoma. 17. Subject with history of medical beauty treatment and taking part in other studies in the last 6 months before study. 18.Use of antihistamines, antibiotics, corticosteroids, non-steroidal anti-inflammatory drugs (NSAIDs), or immunosuppressants within 6 months prior to 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 |
|---|---|---|
| Test soothing facial maskFacial mask containing panthenol and madecassoside, applied on one hemiface for 15 minutes in single use after erythema induction. | Other | Arm A ：Test Facial Mask Side |
Primary outcome
Erythema index measured by Mexameter MX18
Time frame: BL (before infrared induction), T0 (immediately after induction), 10 minutes, 1 hour and 2 hours after induction
Skin erythema index of the hemiface will be measured by Mexameter MX18. Three consecutive valid readings will be taken and averaged for each measurement.
4 secondary outcomes
Dermatologist clinical assessment of skin redness
Time frame: BL (before infrared induction), T0 (immediately after induction), 10 minutes, 1 hour and 2 hours after induction
VISIA-CR facial photography
Time frame: BL (before infrared induction), T0 (immediately after induction), 10 minutes, 1 hour and 2 hours after induction
TiVi700 measurement of skin microcirculation
Time frame: BL (before infrared induction), T0 (immediately after induction), 10 minutes, 1 hour and 2 hours after induction
Subject self-assessment questionnaire for skin sensory symptoms
Time frame: 10 minutes, 1 hour and 2 hours after infrared induction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test soothing facial mask in people with Skin Barrier Function and Skin Soothing Effect, 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 27 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Erythema index measured by Mexameter MX18 (time frame: BL (before infrared induction), T0 (immediately after induction), 10 minutes, 1 hour and 2 hours after induction). 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 27 Oct 2026.