FemaleNCT06985745
Emulsion 8-Week Anti-acne Efficacy Clinical Study
A study testing Standard Cleanser, Investigational emulsion, Standard moisturizer, Standard Sunscreen in people with Female and Male, run by ChinaNorm at 1 site in China.
Trial summary
65 male and female adult subjects will be enrolled in the study, recruited according to inclusion and non-inclusion criteria listed below, at least 60 subjects should complete questionnaire, at least 40 of them should complete clinical assessment, instrumental measurement and image capture. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- What is being tested?
- Standard Cleanser, Investigational emulsion, Standard moisturizer, Standard Sunscreen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 8 Mar 2025to 27 May 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Chinese man and women aged from 20-40 years old.
- Acne prone skin with combination to oil and oil skin type.
- At least 50% self-declared sensitive skin.
- Presenting with mild to moderate IGA (Acne Severity 0-4 scale, 2-3 score). 1) At least 5 inflammatory acne lesions (papules, pustules) on the global face. 2) At least 10 non-inflammatory acne lesions (blackhead, whitehead) on the global face.
- Presenting with Cheek Sebaceous Pores (Skin aging ATLAS Vol.2 Asian Type) ≥ 3 score (0-5 scale)
- At least 1 active inflammatory lesion can be tracked.
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- Subjects with acne red mark (PIE)
- Presenting with skin lack of smoothness, radiance, brightness, softness evaluated by dermatologist and have skin redness concerns.
- 1) Skin smoothness (0-9 scale, 3≤ grade≤ 6) 2) Skin radiance (0-9 scale, 3≤ grade≤ 6) 3) Skin brightness (0-9 scale, 3≤ grade≤ 6) 4) Skin softness (0-9 scale, 3≤ grade≤ 6) 5) Skin redness (0-9 scale, 3≤ grade≤ 6) 9.No disagreement of dermatologist because of other reasons that exclude the participation of the subject.
- 10.In general good health at the time of the study. 11.Willing and able to participate as evidenced by signing of informed consent and photo release form.
- 12.Must be willing to comply with all study protocol requirements
Who cannot join
- Pregnant or breast-feeding woman or woman planning pregnancy during the study. (applicable only to female)
- With facial hair that may interfere with the assessment or image captured of the test area (applicable only to males);
- Unable to participate in the trial according to the study schedule or other situations that are unsuitable for participation (e.g. Subject deprived of rights by a court or administrative order. Major subject to a guardianship order. Subject residing in a health or social care establishment. Patient in an emergency setting.)
- Subject with a skin disease in the test areas (particularly e.g, acne, rosacea, eczema).
- Subjects with history of atopy, allergic reactions, irritation or intense discomfort feelings to topical-use products, medication, cosmetic or personal care products or ingredients.
- Subject presenting a stable or progressive serious disease (per investigator's assessment).
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- Immuno-compromised subject.
- Subject presenting excessive exposure to sunlight or UV radiation (investigator's assessment).
- Subjects regularly practicing aquatic or nautical sports.
- Subjects regularly attending a sauna.
- Subject with cardiovascular or circulatory history.
- Subject with a history of skin cancer or malignant melanoma.
- Anti-aging medical beauty project or anti-aging cosmetics clinical research in the last 6 months before study.
- Participants who took oral isotretinoin capsules within the 6 months prior to the testing period.
- Intake of antihistamines, antibiotics, corticosteroids, non-steroidal anti-inflammatories or immune-suppressants in the last 6 months before study.
- Participants who are currently or have participated in other clinical trials within the past month.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai China-norm Quality Technical Service Co., Ltd.
Shanghai, Shanghai Municipality, 200072
About this study
Official title: An Emulsion 2-Week Wash-out, 4-Week Application and Relapse for 2-Week Anti-acne Efficacy Clinical Study
65 male and female adult subjects will be enrolled in the study, recruited according to inclusion and non-inclusion criteria listed below, at least 60 subjects should complete questionnaire, at least 40 of them should complete clinical assessment, instrumental measurement and image capture. 20 of them should complete lipid sample collection, and at least 30 of them should complete the RCM captured.
- Being tested
- Standard Cleanser, Investigational emulsion, Standard moisturizer, Standard Sunscreen
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Cleanser, Investigational emulsion, Standard moisturizer, Standard SunscreenOther
Products Application and Usage Instruction:
Wash out: T-2W ~ T0
Frequency:
AM: Standard cleanser + standard moisturizer + standard sunscreen PM: Standard cleanser + standard moisturizer Caution: All the products should be applied to full face. No any other skincare or facial make up products are used except provide products.
- Mode of application : 4-week Treatment T0 ~ T4W
Frequency:
AM: Standard cleanser + test emulsion (FLA#2039180 68) + standard sunscreen PM: Standard cleanser + test emulsion (FLA#2039180 68) Caution: All the products should be applied to full face. No other skincare or facial make up products are used except provide products.
- Mode of application : 2-week relapse T4W ~ T6W AM: Standard cleanser + standard moisturizer + standard sunscreen PM: Standard cleanser + standard moisturizer
Usage Instruction： Test emulsion (FLA#2039180 68): Self-application 0.6 ml for full face by hand every day (2x/day).
| Study group | Role | What they receive |
|---|---|---|
| Group Emulsion | Other | Not described Receives: Other: Standard Cleanser, Investigational emulsion, Standard moisturizer, Standard Sunscreen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical scoring for Counting of Acne
Clinical scoring for counting of acne lesions (inflammatory, non-inflammatory, and total), acne severity IGA, and post-inflammatory erythema (PIE) count will be performed by a dermatologist on the global face area. The IGA (Investigator's Global Assessment for acne severity) is rated on a 5-point scale (0 = clear, 4 = severe), as defined in the protocol. PIE is recorded as a numeric count of red marks. Acne lesions (papules, pustules, blackheads, whiteheads) are counted individually.
Measured: Timepoint 2Week before baseline，Baseline, Time point at 1Week , Time point at 4Week, Time point at 5Week, Time point at 6Week.
Clinical scoring for Redness around acne
Clinical scoring for redness around acne will be performed by a dermatologist using a visual scale from 0 to 9, where 0 = no redness and 9 = intense redness, as defined in the protocol. Half-point scores (e.g., 0.5) may be used.
Measured: Baseline，Time point immediate, Time point at 1Day, Time point at 3Day, Time point at 1Week , Time point at 4Week, Time point at 5Week, Time point at 6Week.
Clinical scoring for Diameter of tracking one Acne
The measurement of the diameter of one tracking inflammatory acne lesion will be performed by a dermatologist using a skin ruler. The maximum diameter in millimeters (mm) will be recorded at each time point.
Measured: Baseline，Time point immediate, Time point at 1Day, Time point at 3Day, Time point at 1Week.
Clinical scoring for Cheek Sebaceous Pores
Clinical scoring for cheek sebaceous pores (based on the Skin Aging Atlas, Asian type), as well as for redness, smoothness, radiance, brightness, and softness, will be performed by a dermatologist using a visual grading scale from 0 to 9, as defined in the protocol. Half-point scores (e.g., 0.5) may be used.
Measured: Timepoint 2Week before baseline, Baseline，Time point immediate, Time point at 1Week , Time point at 4Week, Time point at 5Week, Time point at 6Week.
Skin hydration on the cheeks
Skin hydration on the cheeks will be measured by Corneometer® CM 825 by trained technician.
Measured: Baseline, Time point at 1Week , Time point at 4Week, Time point at 5Week, Time point at 6Week.
TEWL on the cheeks
TEWL on the cheeks will be measured by Vapometer by trained technician.
Measured: Baseline, Time point at 1Week , Time point at 4Week, Time point at 5Week, Time point at 6Week.
Sebum secretion on forehead
Sebum secretion on forehead will be measured by Sebumeter® SM 815 by trained technician.
Measured: Baseline, Time point at 1Week , Time point at 4Week, Time point at 5Week, Time point at 6Week.
Image capture and analysis（facial photo）
The facial photo will be captured by VISIA CRP (Canfield, Gen 5.0) on left, front and right sides with Standard 1, Cross-Polarized, Parallel-Polarized, UV operated by trained technician.
-Demo for Pore area, skin reflection under Standard 1 and acne demo under Cross-Polarized.
Measured: Baseline, Time point immediate, Time point at 1Day, Time point at 3Day, Time point at 1Week , Time point at 4Week, Time point at 5Week, Time point at 6Week.
One tracking active acne image
One active inflammatory acne lesion will be imaged using Antera® 3D (Miravex). Image analysis will include acne volume (mm³) and area (mm²), using the Antera 3D CS software.
Measured: Baseline，Time point immediate, Time point at 1Day, Time point at 3Day, Time point at 1Week.
Image Capture and Analysis(RCM)
RCM (Reflectance Confocal Microscopy) will be captured on target acne
-microcomedone ratio, size, hyper-keratin ratio will be analyzed.
Measured: Baseline, Time point 4Week.
Image Capture using VisioScan® VC20plus
Skin image will be captured using VisioScan® VC20plus (Courage + Khazaka) with Sebufix® F 16. Sebum production will be evaluated through sebum spot size and sebum distribution gradient using SELS software.
Measured: Baseline, Time point 4Week.
Secondary outcomes (1)
Consumer Questionnaire
Consumer-reported outcomes will be assessed using a self-assessment questionnaire.
Measured: Time point immediate, Time point at 1Week , Time point at 4Week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start8 Mar 2025
- Primary completion27 May 2025 (estimated)
- Study completion27 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FemaleStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
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
- NCT06985745
- Sponsor's protocol ID
- C25005028
- Status last verified
- May 2025
- First submitted
- 15 May 2025
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This Data Sharing Plan (DSP) aims to promote the open exchange and reuse of de-identified individual participant data (IPD) from cosmetic clinical research, including study protocols, case report forms (CRFs), and statistical analysis plans (SAPs). The shared data will be made available through compliant platforms to eligible researchers in dermatology, cosmetic science, and related fields, following ethical principles and data protection regulations. Users must sign a Data Use Agreement (DUA) to ensure data security, privacy protection, and compliance with research purposes.
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Emulsion 2-Week Wash-out, 4-Week Application and Relapse for 2-Week Anti-acne Efficacy Clinical Study
- ClinicalTrials.gov ID
- NCT06985745
- Acronym / sponsor ID
- C25005028
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 66 participants (actual)
- Lead sponsor
- ChinaNormIndustry (pharma, biotech, devices)
- Study start
- 8 Mar 2025 (actual)
- Primary completion
- 27 May 2025 (estimated)
- Study completion
- 27 May 2025 (estimated)
- First posted
- 22 May 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.
65 male and female adult subjects will be enrolled in the study, recruited according to inclusion and non-inclusion criteria listed below, at least 60 subjects should complete questionnaire, at least 40 of them should complete clinical assessment, instrumental measurement and image capture. 20 of them should complete lipid sample collection, and at least 30 of them should complete the RCM captured.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group Emulsion | Other | Other: Standard Cleanser, Investigational emulsion, Standard moisturizer, Standard Sunscreen |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Chinese man and women aged from 20-40 years old.
- Acne prone skin with combination to oil and oil skin type.
- At least 50% self-declared sensitive skin.
- Presenting with mild to moderate IGA (Acne Severity 0-4 scale, 2-3 score). 1) At least 5 inflammatory acne lesions (papules, pustules) on the global face. 2) At least 10 non-inflammatory acne lesions (blackhead, whitehead) on the global face.
- Presenting with Cheek Sebaceous Pores (Skin aging ATLAS Vol.2 Asian Type) ≥ 3 score (0-5 scale)
Key exclusion criteria (16 listed)
- Pregnant or breast-feeding woman or woman planning pregnancy during the study. (applicable only to female)
- With facial hair that may interfere with the assessment or image captured of the test area (applicable only to males);
- Unable to participate in the trial according to the study schedule or other situations that are unsuitable for participation (e.g. Subject deprived of rights by a court or administrative order. Major subject to a guardianship order. Subject residing in a health or social care establishment. Patient in an emergency setting.)
- Subject with a skin disease in the test areas (particularly e.g, acne, rosacea, eczema).
- Subjects with history of atopy, allergic reactions, irritation or intense discomfort feelings to topical-use products, medication, cosmetic or personal care products or ingredients.
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 |
|---|---|---|
| Standard Cleanser, Investigational emulsion, Standard moisturizer, Standard SunscreenProducts Application and Usage Instruction: Wash out: T-2W ~ T0 Frequency: AM: Standard cleanser + standard moisturizer + standard sunscreen PM: Standard cleanser + standard moisturizer Caution: All the products should be applied to full face. No any other skincare or facial make up products are used except provide products. b. Mode of application : 4-week Treatment T0 ~ T4W Frequency: AM: Standard cleanser + test emulsion (FLA#2039180 68) + standard sunscreen PM: Standard cleanser + test emulsion (FLA#2039180 68) Caution: All the products should be applied to full face. No other skincare or facial make up products are used except provide products. c. Mode of application : 2-week relapse T4W ~ T6W AM: Standard cleanser + standard moisturizer + standard sunscreen PM: Standard cleanser + standard moisturizer Usage Instruction： Test emulsion (FLA#2039180 68): Self-application 0.6 ml for full face by hand every day (2x/day). | Other | Group Emulsion |
Primary outcome
Clinical scoring for Counting of Acne
Time frame: Timepoint 2Week before baseline，Baseline, Time point at 1Week , Time point at 4Week, Time point at 5Week, Time point at 6Week.
Clinical scoring for counting of acne lesions (inflammatory, non-inflammatory, and total), acne severity IGA, and post-inflammatory erythema (PIE) count will be performed by a dermatologist on the global face area. The IGA (Investigator's Global Assessment for acne severity) is rated on a 5-point scale (0 = clear, 4 = severe), as defined in the protocol. PIE is recorded as a numeric count of red marks. Acne lesions (papules, pustules, blackheads, whiteheads) are counted individually.
Clinical scoring for Redness around acne
Time frame: Baseline，Time point immediate, Time point at 1Day, Time point at 3Day, Time point at 1Week , Time point at 4Week, Time point at 5Week, Time point at 6Week.
Clinical scoring for redness around acne will be performed by a dermatologist using a visual scale from 0 to 9, where 0 = no redness and 9 = intense redness, as defined in the protocol. Half-point scores (e.g., 0.5) may be used.
Clinical scoring for Diameter of tracking one Acne
Time frame: Baseline，Time point immediate, Time point at 1Day, Time point at 3Day, Time point at 1Week.
The measurement of the diameter of one tracking inflammatory acne lesion will be performed by a dermatologist using a skin ruler. The maximum diameter in millimeters (mm) will be recorded at each time point.
Clinical scoring for Cheek Sebaceous Pores
Time frame: Timepoint 2Week before baseline, Baseline，Time point immediate, Time point at 1Week , Time point at 4Week, Time point at 5Week, Time point at 6Week.
Clinical scoring for cheek sebaceous pores (based on the Skin Aging Atlas, Asian type), as well as for redness, smoothness, radiance, brightness, and softness, will be performed by a dermatologist using a visual grading scale from 0 to 9, as defined in the protocol. Half-point scores (e.g., 0.5) may be used.
Skin hydration on the cheeks
Time frame: Baseline, Time point at 1Week , Time point at 4Week, Time point at 5Week, Time point at 6Week.
Skin hydration on the cheeks will be measured by Corneometer® CM 825 by trained technician.
TEWL on the cheeks
Time frame: Baseline, Time point at 1Week , Time point at 4Week, Time point at 5Week, Time point at 6Week.
TEWL on the cheeks will be measured by Vapometer by trained technician.
Sebum secretion on forehead
Time frame: Baseline, Time point at 1Week , Time point at 4Week, Time point at 5Week, Time point at 6Week.
Sebum secretion on forehead will be measured by Sebumeter® SM 815 by trained technician.
Image capture and analysis（facial photo）
Time frame: Baseline, Time point immediate, Time point at 1Day, Time point at 3Day, Time point at 1Week , Time point at 4Week, Time point at 5Week, Time point at 6Week.
The facial photo will be captured by VISIA CRP (Canfield, Gen 5.0) on left, front and right sides with Standard 1, Cross-Polarized, Parallel-Polarized, UV operated by trained technician. -Demo for Pore area, skin reflection under Standard 1 and acne demo under Cross-Polarized.
One tracking active acne image
Time frame: Baseline，Time point immediate, Time point at 1Day, Time point at 3Day, Time point at 1Week.
One active inflammatory acne lesion will be imaged using Antera® 3D (Miravex). Image analysis will include acne volume (mm³) and area (mm²), using the Antera 3D CS software.
Image Capture and Analysis(RCM)
Time frame: Baseline, Time point 4Week.
RCM (Reflectance Confocal Microscopy) will be captured on target acne -microcomedone ratio, size, hyper-keratin ratio will be analyzed.
Image Capture using VisioScan® VC20plus
Time frame: Baseline, Time point 4Week.
Skin image will be captured using VisioScan® VC20plus (Courage + Khazaka) with Sebufix® F 16. Sebum production will be evaluated through sebum spot size and sebum distribution gradient using SELS software.
1 secondary outcome
Consumer Questionnaire
Time frame: Time point immediate, Time point at 1Week , Time point at 4Week.
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 30 May 2025.
- Individual participant dataSharing planned: Yes. This Data Sharing Plan (DSP) aims to promote the open exchange and reuse of de-identified individual participant data (IPD) from cosmetic clinical research, including study protocols, case report forms (CRFs), and statistical analysis plans (SAPs). The shared data will be made available through compliant platforms to eligible researchers in dermatology, cosmetic science, and related fields, following ethical principles and data protection regulations. Users must sign a Data Use Agreement (DUA) to ensure data security, privacy protection, and compliance with research purposes.
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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.
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 Standard Cleanser, Investigational emulsion, Standard moisturizer, Standard Sunscreen in people with Female and Male, 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 11 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 30 May 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?
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?
Clinical scoring for Counting of Acne (time frame: Timepoint 2Week before baseline，Baseline, Time point at 1Week , Time point at 4Week, Time point at 5Week, Time point at 6Week.). The study lists 11 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 30 May 2025.