A Pilot Study on the Efficacy of 2% Cholesterol Cream in Preventing Transepidermal Water Loss and Clinical Symptoms in Mild to Moderate Atopic Dermatitis.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Enrollment
- 30
- Locations
- 1
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, 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.
Eligibility Criteria
- Ages
- 7 Years to 17 Years (Child)
- Sex
- All
- Accepts 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