Atopic dermatitis is a common chronic inflammatory skin condition characterized by impaired skin barrier function, leading to increased transepidermal water loss (TEWL), dry skin, and itching. Restoration of the skin barrier is an important component of treatment. Cholesterol is a key lipid in the stratum corneum that plays a role in maintaining skin barrier integrity. This study aims to evaluate the efficacy and safety of 2% cholesterol cream in improving skin barrier function and clinical symptoms in patients with mild to moderate atopic dermatitis aged 7-17 years. Participants will be randomly assigned to receive either 2% cholesterol cream or a placebo (cream base), applied twice daily for 12 weeks. Outcomes will include measurements of transepidermal water loss (TEWL), skin hydration, skin pH, Investigator's Global Assessment (IGA), Eczema Area and Severity Index (EASI), and pruritus numeric rating scale (NRS). The results of this study may support the use of cholesterol-containing topical formulations as a safe and effective treatment option for atopic dermatitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
30
Topical 2% cholesterol cream in an oil-in-water vehicle, applied to antecubital fossae for 12 weeks
Matched placebo cream base (same excipient list, no cholesterol) to antecubital fossae for 12 weeks
Institute of dermatology(inderm)
Bangkok, Thailand
Change in Transepidermal Water Loss (TEWL)
Transepidermal water loss (TEWL) will be measured using a Tewameter at the antecubital fossae. The change from baseline to follow-up visits will be used to assess improvement in skin barrier function.
Time frame: Baseline to Week 12
Change in Skin Hydration
Skin hydration will be measured using a Corneometer at the antecubital fossae. Changes from baseline will be evaluated.
Time frame: Baseline to Week 12
Change in Skin pH
Skin surface pH will be measured using a skin pH meter at the antecubital fossae. Changes from baseline will be analyzed.
Time frame: Baseline to Week 12
Change in Investigator's Global Assessment (IGA) Score
Clinical severity of atopic dermatitis will be assessed using the Investigator's Global Assessment (IGA) score. "Zero is equivalent to no lesion and 4 indicates the worst possible(Severe) eg. Marked erythema (deep or bright red), marked induration/papulation, and/or marked lichenification, Disease is widespread in extent,Oozing or crusting may be present
Time frame: Baseline to Week 12
Change in Eczema Area and Severity Index (EASI)
* severity will be evaluated using the Eczema Area and Severity Index (EASI) score. * Zero is equivalent to no lesion on any part of body and 72 indicates the worst possible lesion on whole body." 0: Clear 0.1 - 1.0: Almost clear 1.1 - 7.0: Mild eczema 7.1 - 21.0: Moderate eczema 21.1 - 50.0: Severe eczema 50.1 - 72.0: Very severe eczema
Time frame: Baseline to Week 12
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