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

May 11, 2026 updated by: Institute of Dermatology, Thailand

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

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 Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10400
        • Institute of dermatology(inderm)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Participants receive topical cream base plus 2% cholesterol on both antecubital fossae.
Participants in this arm will receive 2% cholesterol cream applied twice daily to both arms for 12 weeks. Standard of care will be maintained throughout the study period.
Drug: Topical 2% cholesterol cream
Topical 2% cholesterol cream in an oil-in-water vehicle, applied to antecubital fossae for 12 weeks
Placebo Comparator: Participants receive cream base (oil-in-water formulation) without cholesterol
Participants in this arm will receive cream base (vehicle) applied twice daily to both arms for 12 weeks. Standard of care will be maintained throughout the study period.
Drug: Placebo Vehicle Cream
Matched placebo cream base (same excipient list, no cholesterol) to antecubital fossae for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Transepidermal Water Loss (TEWL)
Time Frame: Baseline to Week 12
Transepidermal water loss (TEWL) will be measured using a Tewameter at the antecubital fossae. The change from baseline to follow-up visits will be used to assess improvement in skin barrier function.
Baseline to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Skin Hydration
Time Frame: Baseline to Week 12
Skin hydration will be measured using a Corneometer at the antecubital fossae. Changes from baseline will be evaluated.
Baseline to Week 12
Change in Skin pH
Time Frame: Baseline to Week 12
Skin surface pH will be measured using a skin pH meter at the antecubital fossae. Changes from baseline will be analyzed.
Baseline to Week 12
Change in Investigator's Global Assessment (IGA) Score
Time Frame: Baseline to Week 12
Clinical severity of atopic dermatitis will be assessed using the Investigator's Global Assessment (IGA) score. "Zero is equivalent to no lesion and 4 indicates the worst possible(Severe) eg. Marked erythema (deep or bright red), marked induration/papulation, and/or marked lichenification, Disease is widespread in extent,Oozing or crusting may be present
Baseline to Week 12
Change in Eczema Area and Severity Index (EASI)
Time Frame: Baseline to Week 12
  • severity will be evaluated using the Eczema Area and Severity Index (EASI) score.
  • Zero is equivalent to no lesion on any part of body and 72 indicates the worst possible lesion on whole body." 0: Clear 0.1 - 1.0: Almost clear 1.1 - 7.0: Mild eczema 7.1 - 21.0: Moderate eczema 21.1 - 50.0: Severe eczema 50.1 - 72.0: Very severe eczema
Baseline to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Dermatology, Thailand

Investigators

  • Study Chair: Chavalit Supsrisunjai, MD, PhD, Institute of dermatology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2026

Primary Completion (Estimated)

December 12, 2026

Study Completion (Estimated)

February 14, 2027

Study Registration Dates

First Submitted

March 25, 2026

First Submitted That Met QC Criteria

March 25, 2026

First Posted (Actual)

March 31, 2026

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001/2568

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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