Acne VulgarisNCT07854418
The Efficacy and Safety of Winona Barrier Special Cream in Post-acne Erythema a Parallel Randomized Controlled Study
An observational study of Acne Vulgaris, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
The goal of this study is to evaluate the efficacy and safety of winona barrier special cream in post-acne erythema(PAE). The main questions it aims to answer are: whether winona barrier special cream can improve facial skin erythema, transepidermal water loss, water content of stratum corneum, pH,melanin, lipidomic… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2023to 30 Jul 2023
- How long will I take part?
- 8 Days
- Phase
- Observational
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Between March 2023 to May 2023, patients diagnosed with post-acne erythema and meeting the inclusion criteria were enrolled in the study from the Department of Dermatology at Jiangsu Provincial People's Hospital.
Who may be able to join
- adults between 18 and 40 years old, regardless of gender;
- comply the clinical diagnostic criteria for post-acne erythema;
- patients understand and are willing to participate in this clinical trial and voluntarily sign an informed consent form;
Who cannot join
- patients with facial comorbidities such as atopic dermatitis, rosacea, seborrheic dermatitis, and other facial skin diseases that may affect the evaluation of efficacy;
- those who have been treated with topical acne or other skin disease medications on the face within 1 month;
- those who have taken oral antibiotics, isotretinoin and other acne systemic treatment drugs within one month;
- Those who have laser, intense pulse light, radio frequency, high-energy focused ultrasound and other photoelectric treatments within one month;
- Those who are using immunosuppressants, antihistamines and antibiotics or efficacious skin care products in the week before enrollment;
- Those who have a history of allergy to the skin care products and ingredients used this time;
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- Those with serious heart, brain, lung, liver and kidney function damage;
- Pregnant and lactating women;
- Those who have a history of psychological and mental illness, recent history of alcoholism or drug abuse;
- patients who are unwilling to sign the informed consent and who are unwilling to cooperate.
Trial locations and contacts
1 site in 1 country.
China1 site
Jiangsu Province Hospital, the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu
About this study
Official title: The Efficacy and Safety of Winona Barrier Special Cream in Post-acne Erythema: a Parallel Randomized Controlled Study
The goal of this study is to evaluate the efficacy and safety of winona barrier special cream in post-acne erythema(PAE). The main questions it aims to answer are: whether winona barrier special cream can improve facial skin erythema, transepidermal water loss, water content of stratum corneum, pH,melanin, lipidomic and microbiodemic in patients with PAE .
type of study:clinical trial participant population/health conditions The study proposes to recruit 60 PAE patients and 20 healthy individuals The checks of patients were randomly selected to use winona barrier special cream on one side and the Basal Water on the other side. the sampes of surface skin are collected on week0, week4 and week8. Measurements of erythema, transepidermal water loss, stratum corneum water content, pH, and melanin were taken from fixed lesion sites on both cheeks before on week0, week4 and week8.
Researchers will compare differences in facial lipidomics and microbiomics between patients' lesion sites and the healthy population, as well as before and after the use of creams by patients to see whether the lipidomics and microbiomics at skin lesions are different in PAE patients compared to the healthy population and whether the intensive care cream has an improved effect on them.
Read the detailed description
This trial is a single-center, randomized controlled study. Eighty subjects are to be recruited. Subjects are divided into a healthy control group (20 people, healthy people without PAE and other inflammatory skin diseases on the face) and a test group (60 people, patients who meet the diagnostic criteria for PAE). Subjects avoided strenuous exercise and sweating for 3 hours before the test, and avoided the use of sunscreen, foundation and other cosmetics. The temperature of the test environment was controlled at 20-25°C and humidity at 45-50%.
At the time of enrollment, patients were informed of the precautions to be taken and signed an informed consent form. The healthy control group used CK sebaceous tape to adhere a 1-cm skin sample from the lateral side of the cheeks and nose at the level of both cheeks and noses for multi-histological testing (sebum, microbiology, and other histological analyses) in order to compare the facial histological differences between the healthy individuals and the patients with PAE.
The test group was 60 people, using the left and right half of the face in an auto-control manner, randomly selected to use the Winona Barrier Multi-Repair Cream on one cheek and the Base Cream on the other. One erythematous area on each cheek was selected at the time of enrollment, and skin elasticity was measured using Cutometer® Dual MPA580 (Courage+Khazaka, Germany), stratum corneum water content was measured using Corneometer CM825 (Courage+Khazaka, Germany), and water content of the stratum corneum was measured using Sebumeter® SM815 (Courage+Khazaka, Germany) for sebum content, Tewameter® (Courage+Khazaka, Germany) for transepidermal water loss (TEWL) and pH-Meter PH905 (Courage+Khazaka, Germany) for pH, Mexameter® MX18 (Courage+Khazaka, Germany) for melanin and erythema; L*, a*, b* values were measured with an L*a*b* colorimeter (Konica-Minolta, Japan); and skin samples were adhered to a CK sebaceous tape (Courage+Khazaka, Germany) for a multihistological test. (sebum, microorganisms, etc.); VISIA® (Canfield, USA) skin image analyzer was used to collect frontal, left and right photographs of the patient's face. The patients were followed up at weeks 4 and 8 to record any adverse reactions, and the above skin physiological parameters and dermatologic sampling were performed in the same erythematous area. Frontal, left and right photographs of the patient's face at the end of treatment were taken at week 8 using the VISIA® Skin Image Analyzer.
The efficacy of the treatment was assessed by comparing the differences between the treated and non-treated erythema, skin test indices, and histologic findings in control patients. The safety of the treatment was assessed by the presence or absence of adverse effects. The effect of treatment on skin metabolomics was also assessed by comparing skin metabolomic differences between PAE patients before and after treatment and with normal subjects.
- Conditions
- Acne Vulgaris
- Being tested
- Treatment and control groups
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment and control groupsOther
The checks of patients were randomly selected to use winona barrier special cream on one side and the Basal Water on the other side. the sampes of surface skin are collected on week0, week4 and week8. Measurements of erythema, transepidermal water loss, stratum corneum water content, pH, and melanin were taken from fixed lesion sites on both cheeks before on week0, week4 and week8.
| Study group | Role | What they receive |
|---|---|---|
| PAE patients | the patients Receives: Other: Treatment and control groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Aesthetic Improvement Scale (GAIS) score
The overall aesthetic improvement of facial skin will be assessed by a blinded evaluator using the Global Aesthetic Improvement Scale (GAIS). The GAIS score will be assigned to each side of the face according to the following criteria: -1 = worsened; 0 = no improvement; 1 = slight improvement; 2 = marked improvement; 3 = near complete recovery. The assessment will be performed at 3 days and 7 days after treatment.
Measured: 3 days (T3d) and 7 days (T7d) after treatment
Secondary outcomes (4)
Transepidermal water loss (TEWL)
Transepidermal water loss (TEWL) will be measured using the GPSkin Barrier skin physiological measurement device (GPOWER, Republic of Korea). Measurements will be obtained at the predefined facial cheek site, located at the intersection of the vertical line through the center of the eye and the horizontal line through the center of the nasal bridge. TEWL will be recorded in g/(m²·h).
Measured: Baseline (BL), immediately after treatment (Timm), 2 hours after treatment (T2h), 3 days after treatment (T3d), and 7 days after treatment (T7d)
Stratum corneum hydration (SCH)
Measurements will be obtained at the predefined facial cheek site, located at the intersection of the vertical line through the center of the eye and the horizontal line through the center of the nasal bridge.
Measured: Baseline (BL), immediately after treatment (Timm), 2 hours after treatment (T2h), 3 days after treatment (T3d), and 7 days after treatment (T7d)
CIELAB a* value measured by colorimetry
The CIELAB a* value of facial skin will be measured using a CM-700d spectrophotometer (Konica Minolta, Japan). Measurements will be obtained at the predefined facial cheek site, located at the intersection of the vertical line through the center of the eye and the horizontal line through the center of the nasal tip.
Measured: Baseline (BL), immediately after treatment (Timm), 2 hours after treatment (T2h), 3 days after treatment (T3d), and 7 days after treatment (T7d)
Facial red area percentage assessed by VISIA imaging
Standardized facial images will be acquired using the VISIA facial imaging system (Canfield Scientific, USA), with imaging of the left, central, and right cheek regions. The percentage of facial red area will be quantitatively analyzed from the acquired images using Image-Pro Plus (IPP) software.
Measured: Baseline (BL) and 7 days after treatment (T7d)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start1 Apr 2023
- Primary completion30 Jul 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
- Target duration
- 8 Days
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yang Xu, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07854418
- Sponsor's protocol ID
- 2023-SR-338
- Status last verified
- Jul 2023
- First submitted
- 1 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Winona Barrier Special Cream in Post-acne Erythema: a Parallel Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07854418
- Acronym / sponsor ID
- 2023-SR-338
- Conditions
- Acne Vulgaris
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 2 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 study is to evaluate the efficacy and safety of winona barrier special cream in post-acne erythema(PAE). The main questions it aims to answer are: whether winona barrier special cream can improve facial skin erythema, transepidermal water loss, water content of stratum corneum, pH,melanin, lipidomic and microbiodemic in patients with PAE .
type of study:clinical trial participant population/health conditions The study proposes to recruit 60 PAE patients and 20 healthy individuals The checks of patients were randomly selected to use winona barrier special cream on one side and the Basal Water on the other side. the sampes of surface skin are collected on week0, week4 and week8. Measurements of erythema, transepidermal water loss, stratum corneum water content, pH, and melanin were taken from fixed lesion sites on both cheeks before on week0, week4 and week8.
Researchers will compare differences in facial lipidomics and microbiomics between patients' lesion sites and the healthy population, as well as before and after the use of creams by patients to see whether the lipidomics and microbiomics at skin lesions are different in PAE patients compared to the healthy population and whether the intensive care cream has an improved effect on them.
Detailed description
This trial is a single-center, randomized controlled study. Eighty subjects are to be recruited. Subjects are divided into a healthy control group (20 people, healthy people without PAE and other inflammatory skin diseases on the face) and a test group (60 people, patients who meet the diagnostic criteria for PAE). Subjects avoided strenuous exercise and sweating for 3 hours before the test, and avoided the use of sunscreen, foundation and other cosmetics. The temperature of the test environment was controlled at 20-25°C and humidity at 45-50%.
At the time of enrollment, patients were informed of the precautions to be taken and signed an informed consent form. The healthy control group used CK sebaceous tape to adhere a 1-cm skin sample from the lateral side of the cheeks and nose at the level of both cheeks and noses for multi-histological testing (sebum, microbiology, and other histological analyses) in order to compare the facial histological differences between the healthy individuals and the patients with PAE.
The test group was 60 people, using the left and right half of the face in an auto-control manner, randomly selected to use the Winona Barrier Multi-Repair Cream on one cheek and the Base Cream on the other. One erythematous area on each cheek was selected at the time of enrollment, and skin elasticity was measured using Cutometer® Dual MPA580 (Courage+Khazaka, Germany), stratum corneum water content was measured using Corneometer CM825 (Courage+Khazaka, Germany), and water content of the stratum corneum was measured using Sebumeter® SM815 (Courage+Khazaka, Germany) for sebum content, Tewameter® (Courage+Khazaka, Germany) for transepidermal water loss (TEWL) and pH-Meter PH905 (Courage+Khazaka, Germany) for pH, Mexameter® MX18 (Courage+Khazaka, Germany) for melanin and erythema; L*, a*, b* values were measured with an L*a*b* colorimeter (Konica-Minolta, Japan); and skin samples were adhered to a CK sebaceous tape (Courage+Khazaka, Germany) for a multihistological test. (sebum, microorganisms, etc.); VISIA® (Canfield, USA) skin image analyzer was used to collect frontal, left and right photographs of the patient's face. The patients were followed up at weeks 4 and 8 to record any adverse reactions, and the above skin physiological parameters and dermatologic sampling were performed in the same erythematous area. Frontal, left and right photographs of the patient's face at the end of treatment were taken at week 8 using the VISIA® Skin Image Analyzer.
The efficacy of the treatment was assessed by comparing the differences between the treated and non-treated erythema, skin test indices, and histologic findings in control patients. The safety of the treatment was assessed by the presence or absence of adverse effects. The effect of treatment on skin metabolomics was also assessed by comparing skin metabolomic differences between PAE patients before and after treatment and with normal subjects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 8 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PAE patients | – | Other: Treatment and control groupsthe patients |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Between March 2023 to May 2023, patients diagnosed with post-acne erythema and meeting the inclusion criteria were enrolled in the study from the Department of Dermatology at Jiangsu Provincial People's Hospital.
Key inclusion criteria (3 listed)
- adults between 18 and 40 years old, regardless of gender;
- comply the clinical diagnostic criteria for post-acne erythema;
- patients understand and are willing to participate in this clinical trial and voluntarily sign an informed consent form;
Key exclusion criteria (10 listed)
- patients with facial comorbidities such as atopic dermatitis, rosacea, seborrheic dermatitis, and other facial skin diseases that may affect the evaluation of efficacy;
- those who have been treated with topical acne or other skin disease medications on the face within 1 month;
- those who have taken oral antibiotics, isotretinoin and other acne systemic treatment drugs within one month;
- Those who have laser, intense pulse light, radio frequency, high-energy focused ultrasound and other photoelectric treatments within one month;
- Those who are using immunosuppressants, antihistamines and antibiotics or efficacious skin care products in the week before enrollment;
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 |
|---|---|---|
| Treatment and control groupsThe checks of patients were randomly selected to use winona barrier special cream on one side and the Basal Water on the other side. the sampes of surface skin are collected on week0, week4 and week8. Measurements of erythema, transepidermal water loss, stratum corneum water content, pH, and melanin were taken from fixed lesion sites on both cheeks before on week0, week4 and week8. | Other | PAE patients |
Primary outcome
Global Aesthetic Improvement Scale (GAIS) score
Time frame: 3 days (T3d) and 7 days (T7d) after treatment
The overall aesthetic improvement of facial skin will be assessed by a blinded evaluator using the Global Aesthetic Improvement Scale (GAIS). The GAIS score will be assigned to each side of the face according to the following criteria: -1 = worsened; 0 = no improvement; 1 = slight improvement; 2 = marked improvement; 3 = near complete recovery. The assessment will be performed at 3 days and 7 days after treatment.
4 secondary outcomes
Transepidermal water loss (TEWL)
Time frame: Baseline (BL), immediately after treatment (Timm), 2 hours after treatment (T2h), 3 days after treatment (T3d), and 7 days after treatment (T7d)
Stratum corneum hydration (SCH)
Time frame: Baseline (BL), immediately after treatment (Timm), 2 hours after treatment (T2h), 3 days after treatment (T3d), and 7 days after treatment (T7d)
CIELAB a* value measured by colorimetry
Time frame: Baseline (BL), immediately after treatment (Timm), 2 hours after treatment (T2h), 3 days after treatment (T3d), and 7 days after treatment (T7d)
Facial red area percentage assessed by VISIA imaging
Time frame: Baseline (BL) and 7 days after treatment (T7d)
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 2 Oct 2026.
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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.
Yang Xu principal investigator
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acne Vulgaris, run by The First Affiliated Hospital with Nanjing Medical University 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 3 inclusion and 10 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 2 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?
Global Aesthetic Improvement Scale (GAIS) score (time frame: 3 days (T3d) and 7 days (T7d) after treatment). 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 2 Oct 2026.