Trials / Enrolling By Invitation
Enrolling By InvitationNCT07503197
A Pilot Study on the Efficacy of 2% Cholesterol Cream in Preventing Transepidermal Water Loss and Clinical Symptoms in Mild to Moderate Atopic Dermatitis
A Pilot Study on the Efficacy of 2% Cholesterol Cream in Preventing Transepidermal Water Loss and Clinical Symptoms in Mild to Moderate Atopic Dermatitis.
- Status
- Enrolling By Invitation
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Institute of Dermatology, Thailand · Other Government
- Sex
- All
- Age
- 7 Years – 17 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Atopic Dermatitis (AD)
- Cholesterol
- Skin Barrier to Water Loss
- Skin Allergy
- Eczema Atopic Dermatitis
- Trans Epidermal Water Loss
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2026-04-01
- Primary completion
- 2026-12-12
- Completion
- 2027-02-14
- First posted
- 2026-03-31
- Last updated
- 2026-03-31
Locations
1 site across 1 country: Thailand
Source: ClinicalTrials.gov record NCT07503197. Inclusion in this directory is not an endorsement.