Acne vulgaris, pimples, papules, pustules
Conditions
Interventions
Marketed functional skincare product group:Cicaplast Balm B5+
Ordinary Moisturizer group:Standard Moisturizer
Sponsors
Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1.Chinese males and females aged 18-40 years, in generally good health. 2.Meet the diagnostic criteria for moderate to severe/Grade III-IV acne (Pillsbury classification) and are eligible for oral isotretinoin treatment. Grade III: numerous papules and pustules, with a total of 50-100 lesions and fewer than 3 nodules. Grade IV: nodulocystic or conglobate acne, with more than 100 total lesions and more than 3 nodules/cysts. 3.Have not received acne medications affecting the skin barrier (e.g., oral isotretinoin, topical benzoyl peroxide) or physical/chemical treatments within the past month. Anti-inflammatory and antibacterial medications are allowed. 4.Have signed the informed consent form and possess good oral and written communication and comprehension skills. 5.Demonstrate good adherence to the study protocol, willing to follow the study plan throughout the research period, use only the provided medication and products, refrain from using other medications and products, maintain a diary, and attend regular follow-ups.
Exclusion criteria
Exclusion criteria: 1.Women who are pregnant, breastfeeding, or planning pregnancy. 2.Special types of acne: conglobate acne, necrotic acne, secondary acne, etc. 3.Systemic diseases with severe organ damage, malignant tumors, uncontrolled chronic diseases, acute infectious diseases, major surgeries or trauma, psychological and mental disorders, or requiring local or systemic medications/treatments that may affect acne due to other conditions. 4.Presence of other skin diseases in the study area (e.g., rosacea, dermatitis, eczema, infections, tumors) or other skin conditions that may interfere with the evaluation (e.g., birthmarks, scars). 5.Use of topical medications and functional skincare products within the past 2 weeks. 6.Underwent physical, chemical, or cosmetic surgical treatments within the past 3 months. 7.Habit of scratching or squeezing acne lesions. 8.History of allergies to the medications, products, or related components provided in the study. 9.Simultaneous participation in other clinical studies during the study period, refusal to sign the informed consent form, or poor compliance. 10.Other conditions deemed unsuitable for the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Transepidermal Water Loss; | — |
Secondary
| Measure | Time frame |
|---|---|
| Water contents of Stratum Corneum;Skin pH detection;Acne Severity Evaluation;Count the numbers of open comedones, closed comedones, papules, pustules, PIE and PIH;clinician’s erythema assessment scale, CEAS;PIE, PIH pigmentation level assessment, skin color evenness assessment;Skin sensitivity/tolerance self-assessment;Lesions improvement;Microbiome assessment;Laboratory examination of the safety of isotretinoin use in patients; | — |
Countries
China
Contacts
Public ContactQiang Ju
Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed