Evaluation of the efficacy and safety of skin-microbiome-derived skin barrier-enhancing cosmetics in atopic dermatitis: a proof-of-concept trial
- Conditions
- Diseases of the skin and subcutaneous tissue
- Registration Number
- KCT0007876
- Lead Sponsor
- Korean Skin Research Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
1)Male or female volunteers aged 12 to 70 years with a diagnosis of atopic dermatitis IGA = 2 or 3 at screening and prior to product use
2)Volunteers with mild to moderate atopic dermatitis IGA = 2 or 3 at screening and prior to product use
3)Volunteers who have applied a stable dose of moisturizer at least once daily for at least 7 consecutive days prior to study entry
4)Volunteers who have been fully informed about the study and have voluntarily completed and signed an informed consent form.
5)Volunteers who can be followed up for the duration of the study
1)Treatment with immunosuppressive/immunomodulatory medications or phototherapy for atopic dermatitis within the last 4 weeks or volunteers who, in the opinion of the investigator, are likely to require such treatment(s) during the 4-week period.
2)Volunteers treated with topical corticosteroids or topical calcineurin inhibitors within the last 2 weeks
3)Volunteers who have been treated with a biologic agent (e.g., omalizumab, dupilumab, and infliximab) within the last 16 weeks
4)Volunteers who have started treatment for atopic dermatitis with a new moisturizer prescription during the screening period
5)Volunteers planning or using any prohibited treatment during the study period
6)Volunteers who have been treated with a live (attenuated) vaccine within the last 12 weeks
7)Volunteers requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within the last 2 weeks
8)Volunteers with an active chronic or acute infection
9)Volunteers with a serious skin infection or skin disease within the last 1 week that may interfere with the study evaluation
10)Volunteers with chronic urticaria or active pruritus due to allergens such as scabies or insect bites within the past 1 week
11)Applicants with a history of human immunodeficiency virus (HIV) infection or a positive HIV serologic test at screening
12)Applicants with a history of alcohol or drug abuse within 2 years
13)Applicants with acute or chronic hepatitis or known cirrhosis
14)Volunteers with a history of malignancy within 5 years
15)Volunteers with comorbid severe condition(s) as determined by the investigator
16)Volunteers with planned or anticipated significant surgery during this period
17)Volunteers who are employees or family members of the study
18)Female volunteers who are pregnant or lactating or who plan to become pregnant or lactate during the study
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method IGA (Investigator’s Global Assessment)
- Secondary Outcome Measures
Name Time Method Measurement of pruritus visual analog scale (VAS) ;Measurement of skin hydration and transepidermal water loss (TEWL) ;EASI (Eczema area and severity index) score