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NCT Number: NCT07503197

A Study on the Efficacy of 2% Cholesterol Cream in 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.

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Key information

Conditions

Atopic Dermatitis (AD) Cholesterol Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Eczema Atopic Dermatitis Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Allergy Skin Barrier to Water Loss Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases Trans Epidermal Water Loss

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of dermatology(inderm)

Bangkok, 10400, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Topical 2% cholesterol cream

Drug

Topical 2% cholesterol cream in an oil-in-water vehicle, applied to antecubital fossae for 12 weeks

Placebo Vehicle Cream

Drug

Matched placebo cream base (same excipient list, no cholesterol) to antecubital fossae for 12 weeks

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Institute of Dermatology, Thailand

Other Gov

Registry information

Official study 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.

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Mar 31, 2026
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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