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ENROLLING BY INVITATION
NCT07503197
NA

A Pilot Study on the Efficacy of 2% Cholesterol Cream in Preventing Transepidermal Water Loss and Clinical Symptoms in Mild to Moderate Atopic Dermatitis

Sponsor: Institute of Dermatology, Thailand

View on ClinicalTrials.gov

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.

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.

Key Details

Gender

All

Age Range

7 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-04-01

Completion Date

2027-02-14

Last Updated

2026-03-31

Healthy Volunteers

No

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

Locations (1)

Institute of dermatology(inderm)

Bangkok, Thailand