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

NCT07503197 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-14

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Institute of Dermatology, Thailand

    lead OTHER_GOV

Principal Investigators

  • Chavalit Supsrisunjai, MD, PhD · Institute of dermatology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07503197 on ClinicalTrials.gov