Atopic Dermatitis (AD), Cholesterol, Eczema Atopic Dermatitis, Skin Allergy, Skin Barrier to Water Loss, Trans Epidermal Water Loss
Conditions
Brief summary
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.
Interventions
DRUGTopical 2% cholesterol cream
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
Sponsors
Institute of Dermatology, Thailand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
7 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
: * Thai nationality * Aged between 7-17 years * Able to read and write Thai fluently * Clinically diagnosed with mild to moderate atopic dermatitis, with lesions located on both antecubital fossae, according to the Hanifin and Rajka criteria * Investigator's Global Assessment (IGA) score of 1-3 * Eczema Area and Severity Index (EASI) score between 0.2-21
Exclusion criteria
: * Presence of other dermatologic conditions other than atopic dermatitis * Use of systemic immunosuppressive therapy (e.g., prednisolone, dupilumab, JAK inhibitors) * History of chronic infections such as hepatitis B, hepatitis C, herpes zoster, or tuberculosis * History of any malignancy * Pregnant or breastfeeding women, or those planning pregnancy during the study period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Transepidermal Water Loss (TEWL) | Baseline to Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Skin Hydration | Baseline to Week 12 | Skin hydration will be measured using a Corneometer at the antecubital fossae. Changes from baseline will be evaluated. |
| Change in Skin pH | Baseline to Week 12 | Skin surface pH will be measured using a skin pH meter at the antecubital fossae. Changes from baseline will be analyzed. |
| Change in Investigator's Global Assessment (IGA) Score | Baseline to Week 12 | 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 |
| Change in Eczema Area and Severity Index (EASI) | Baseline to Week 12 | * 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 |
Countries
Thailand
Contacts
STUDY_CHAIRChavalit Supsrisunjai, MD, PhD
Institute of dermatology
Outcome results
None listed