A Study on the Efficacy of 2% Cholesterol Cream in Atopic Dermatitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Topical 2% cholesterol cream, Placebo Vehicle Cream.
- Who it may be relevant to
- Registry conditions: Atopic Dermatitis (AD), Cholesterol, Skin Barrier to Water Loss, Skin Allergy. Basic parameters: 7 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Thailand
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Pilot Study on the Efficacy of 2% Cholesterol Cream in Preventing Transepidermal Water Loss and Clinical Symptoms in Mild to Moderate Atopic Dermatitis.
Overview
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
- Drug Topical 2% cholesterol cream
Topical 2% cholesterol cream in an oil-in-water vehicle, applied to antecubital fossae for 12 weeks - Drug Placebo Vehicle Cream
Matched placebo cream base (same excipient list, no cholesterol) to antecubital fossae for 12 weeks
Primary outcome measures
- Change in Transepidermal Water Loss (TEWL) [Time frame: Baseline to Week 12]
Secondary outcome measures (4)
- Change in Skin Hydration [Time frame: Baseline to Week 12]
- Change in Skin pH [Time frame: Baseline to Week 12]
- Change in Investigator's Global Assessment (IGA) Score [Time frame: Baseline to Week 12]
- Change in Eczema Area and Severity Index (EASI) [Time frame: Baseline to Week 12]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Thailand · 1 center
- Institute of dermatology(inderm) — Bangkok
Identifiers
NCT: NCT07503197 · 001/2568