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

NCT07503197 | Enrolling By Invitation DMC

• 1 other identifier: 001/2568
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in Transepidermal Water Loss (TEWL)

  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 Outcomes (4)

• Change in Skin Hydration

  Baseline to Week 12

• Change in Skin pH

  Baseline to Week 12

• Change in Investigator's Global Assessment (IGA) Score

  Baseline to Week 12

• Change in Eczema Area and Severity Index (EASI)

  Baseline to Week 12

Study Arms (2)

Participants receive topical cream base plus 2% cholesterol on both antecubital fossae.

EXPERIMENTAL

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

Participants receive cream base (oil-in-water formulation) without cholesterol

PLACEBO COMPARATOR

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

Interventions

Topical 2% cholesterol cream DRUG

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

Participants receive topical cream base plus 2% cholesterol on both antecubital fossae.

Placebo Vehicle Cream DRUG

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

Participants receive cream base (oil-in-water formulation) without cholesterol

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Dermatology, Thailand: lead

Study Sites (1)

Institute of dermatology(inderm)

Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Chavalit Supsrisunjai, MD, PhD

  Institute of dermatology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study is double-blind. Participants and investigators assessing outcomes will be blinded to treatment allocation. The active and placebo creams are identical in appearance, packaging, and labeling.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Participants will be randomized in a 1:1 ratio into two parallel groups to receive either 2% cholesterol cream or placebo. Both groups will receive standard of care. The study is designed as a randomized, double-blind, vehicle-controlled trial.

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: March 31, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 12, 2026
• Study Completion (Estimated): February 14, 2027
• Last Updated: May 14, 2026

Record last verified: 2026-05

Locations

TH (1)