Atopic Dermatitis (AD)NCT07503197
A Study on the Efficacy of 2% Cholesterol Cream in Atopic Dermatitis
A study testing Topical 2% cholesterol cream in people with Atopic Dermatitis (AD) and Cholesterol, run by Institute of Dermatology, Thailand at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Atopic Dermatitis (AD), Cholesterol, Skin Barrier to Water Loss
- What is being tested?
- Topical 2% cholesterol cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteThailand
- Study dates
- 1 Apr 2026to 14 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
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
- Being tested
- Topical 2% cholesterol cream, Placebo Vehicle Cream
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical 2% cholesterol creamDrug
Topical 2% cholesterol cream in an oil-in-water vehicle, applied to antecubital fossae for 12 weeks
Placebo Vehicle CreamDrug
Matched placebo cream base (same excipient list, no cholesterol) to antecubital fossae for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo Vehicle Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 12
Secondary outcomes (4)
Change in Skin Hydration
Skin hydration will be measured using a Corneometer at the antecubital fossae. Changes from baseline will be evaluated.
Measured: Baseline to Week 12
Change in Skin pH
Skin surface pH will be measured using a skin pH meter at the antecubital fossae. Changes from baseline will be analyzed.
Measured: Baseline to Week 12
Change in Investigator's Global Assessment (IGA) Score
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
Measured: Baseline to Week 12
Change in Eczema Area and Severity Index (EASI)
- 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
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start1 Apr 2026
- Primary completion12 Dec 2026 (estimated)
- Study completion14 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis (AD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Dermatology, Thailand
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Chavalit Supsrisunjai, MD, PhD, Study chair, Institute of dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07503197
- Sponsor's protocol ID
- 001/2568
- Status last verified
- May 2026
- First submitted
- 25 Mar 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07503197
- Acronym / sponsor ID
- 001/2568
- Conditions
- Atopic Dermatitis (AD), Cholesterol, Skin Barrier to Water Loss, Skin Allergy, Eczema Atopic Dermatitis, Trans Epidermal Water Loss
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Institute of Dermatology, ThailandOther government
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 12 Dec 2026 (estimated)
- Study completion
- 14 Feb 2027 (estimated)
- First posted
- 31 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Participants receive topical cream base plus 2% cholesterol on both antecubital fossae. | Experimental | Drug: Topical 2% cholesterol creamParticipants 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. |
| Participants receive cream base (oil-in-water formulation) without cholesterol | Placebo comparator | Drug: Placebo Vehicle CreamParticipants 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. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical 2% cholesterol creamTopical 2% cholesterol cream in an oil-in-water vehicle, applied to antecubital fossae for 12 weeks | Drug | Participants receive topical cream base plus 2% cholesterol on both antecubital fossae. |
| Placebo Vehicle CreamMatched placebo cream base (same excipient list, no cholesterol) to antecubital fossae for 12 weeks | Drug | Participants receive cream base (oil-in-water formulation) without cholesterol |
Primary outcome
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.
4 secondary outcomes
Change in Skin Hydration
Time frame: Baseline to Week 12
Change in Skin pH
Time frame: Baseline to Week 12
Change in Investigator's Global Assessment (IGA) Score
Time frame: Baseline to Week 12
Change in Eczema Area and Severity Index (EASI)
Time frame: Baseline to Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chavalit Supsrisunjai, MD, PhD study chair
Institute of dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical 2% cholesterol cream in people with Atopic Dermatitis (AD) and Cholesterol, run by Institute of Dermatology, Thailand at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Transepidermal Water Loss (TEWL) (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.