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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants receive topical cream base plus 2% cholesterol on both antecubital fossae. | Experimental | Participants in this arm will receive 2% cholesterol cream applied twice daily to both arms for 12 weeks. Standard of care will be maintained throughout the study period. |
|
| Participants receive cream base (oil-in-water formulation) without cholesterol | Placebo Comparator | Participants in this arm will receive cream base (vehicle) applied twice daily to both arms for 12 weeks. Standard of care will be maintained throughout the study period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical 2% cholesterol cream | Drug | Topical 2% cholesterol cream in an oil-in-water vehicle, applied to antecubital fossae for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Skin Hydration | Skin hydration will be measured using a Corneometer at the antecubital fossae. Changes from baseline will be evaluated. | 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. |
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Inclusion Criteria :
Exclusion Criteria :
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| Name | Affiliation | Role |
|---|---|---|
| Chavalit Supsrisunjai, MD, PhD | Institute of dermatology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of dermatology(inderm) | Bangkok | 10400 | Thailand |
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Participants will be randomized in a 1:1 ratio into two parallel groups to receive either 2% cholesterol cream or placebo. Both groups will receive standard of care. The study is designed as a randomized, double-blind, vehicle-controlled trial.
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This study is double-blind. Participants and investigators assessing outcomes will be blinded to treatment allocation. The active and placebo creams are identical in appearance, packaging, and labeling.
| Placebo Vehicle Cream | Drug | Matched placebo cream base (same excipient list, no cholesterol) to antecubital fossae for 12 weeks |
|
| 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 | Baseline to Week 12 |
| Change in Eczema Area and Severity Index (EASI) |
| Baseline to Week 12 |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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