The Efficacy and Safety of Winona Barrier Special Cream in Post-acne Erythema a Parallel Randomized Controlled Study

NCT07854418 | Completed DMC

• 1 other identifier: 2023-SR-338
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• 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.

  3 days (T3d) and 7 days (T7d) after treatment

Secondary Outcomes (4)

• Transepidermal water loss (TEWL)

  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)

  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

  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

  Baseline (BL) and 7 days after treatment (T7d)

Study Arms (1)

PAE patients

the patients

Other: Treatment and control groups

Interventions

Treatment and control groups OTHER

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.

PAE patients

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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;

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

Jiangsu Province Hospital, the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

epidermal tissue obtained using tapes

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Therapeutics; Control Groups

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Yang Xu

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 8 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: October 2, 2026
• Study Start: April 1, 2023
• Primary Completion: July 30, 2023
• Study Completion: July 30, 2023
• Last Updated: October 2, 2026

Record last verified: 2023-07

Locations

CN (1)