Clinical Trial of an Ointment in Patients With Mild and Moderate Atopic Dermatitis

AD global severity will be assessed using the SCORAD index, a validated clinical tool. The intensity of redness, swelling, oozing/ crusting, scratch marks, lichenification and dryness will be measured over the whole body. Subjective symptoms of itch and sleeplessness were measured and skin lesion photographs were taken at every visit.

Transepidermal water loss (TEWL) will be measured to assess changes in skin barrier function at baseline and after treatment using a moisturizer. Measurements will be performed on predefined lesional skin areas using GPSKIN barrier research solution 1 device (GPOWER Inc., Gyeonggi-do, South Korea) throughout the 12-week treatment, under standardized environmental conditions (room temperature 19-25°C and relative humidity 50-58%). Participants will be instructed to avoid applying topical products to the assessment site for at least 12 hours and to acclimatize in the examination room for 15 minutes before measurement. Three consecutive TEWL readings will be obtained at each assessment, and the mean value, expressed in g/m²/h, will be used for analysis.

Stratum corneum hydration (SCH) will be assessed to evaluate changes in skin moisture content at baseline and after treatment using a moisturizer. Measurements will be performed on the same predefined lesional skin areas using GPSKIN barrier research solution 1 device (GPOWER Inc., Gyeonggi-do, South Korea) throughout the 12-week treatment, under standardized environmental conditions (room temperature 19-25°C and relative humidity 50-58%). Participants will be instructed to avoid applying topical products to the assessment site for at least 12 hours and to acclimatize in the examination room for 15-20 minutes before measurement. Three consecutive SCH readings will be obtained at each assessment, and the mean value, expressed in arbitrary units (a.u.) will be used for analysis.

Cytokine levels of interleukin (IL)-4, IL-13, IL-5 and thymic stromal lymphopoietin (TSLP) in serum will be analyzed using ELISA cytokine kits, Duoset (Bio-Techne, Minneapolis, MN, USA) according to the manufacturer's recommendations.

Adverse events will be categorized as local or systemic and will be graded according to severity. Mild local adverse events will include feelings of stickiness after application, changes in clothing color, and increased sensitivity to sunlight. Moderate local adverse events will include sensitive skin irritation (e.g., itching, stinging, and burning sensations), irritant contact dermatitis characterized by erythema, mild edema, and scaling, allergic contact dermatitis presenting with erythema, vesiculation, edema, and bullae formation, as well as contact urticaria. Severe local adverse events will include eczema. Mild systemic adverse events will include headache, nausea, and dizziness. Moderate systemic adverse events will include dyspnea, while severe systemic adverse events will include anaphylaxis. All adverse events will be monitored throughout the study and will be recorded according to their severity and their potential relationship to the study treatment.

A survey of satisfaction after using products will be collected from all patients in both groups. The detail of survey will be description in Appendix 05. Total score will be collected and classified base on the scale such as 0-5: unsatisfied, 6-15: normal, 16-24: satisfied.