drugset / Trial / NCT07503197

A Study on the Efficacy of 2% Cholesterol Cream in Atopic Dermatitis

NCT07503197

Enrolling by invitation 30 enrolled Institute of Dermatology, Thailand
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2026-04-01
Primary completion
2026-12-12
Completion
2027-02-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Cholesterol Small molecule 2 % Topical

Indications