Xanthelasma PalpebrarumPhase 2STAT-LIDNCT07662785
Topical 2% Simvastatin for Xanthelasma Palpebrarum
A Phase 2 study testing Topical Simvastatin 2% Cream in people with Xanthelasma Palpebrarum, run by Klira Skin.
Trial summary
This study is evaluating whether a topical cream containing 2% simvastatin can improve xanthelasma palpebrarum, a common condition that causes yellow cholesterol deposits on the eyelids. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Xanthelasma Palpebrarum
- What is being tested?
- Topical Simvastatin 2% Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 1 Sep 2027
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Clinical diagnosis of xanthelasma palpebrarum confirmed by a study investigator
- At least one measurable periocular xanthelasma lesion
- No procedural treatment to the study lesion(s) within the past 3 months, including excision, laser, cryotherapy, chemical cautery/trichloroacetic acid, electrocautery, or radiofrequency
- Capacity to provide informed consent
- Willingness to avoid other treatments for xanthelasma during the study
Who cannot join
- Known allergy or sensitivity to any study cream ingredient
- Active periocular inflammatory disease
- Use of topical eyelid treatments within the past 4 weeks, including topical corticosteroids, retinoids, acid peels, depigmenting agents, compounded creams, or over-the-counter eye creams containing active ingredients
- Pregnancy or breastfeeding
- Participation in another interventional clinical trial
- Current unstable systemic lipid-lowering therapy
- Initiation of, or dose change to, oral statin therapy within the past 8 weeks
- Any condition judged by the investigator to make participation unsafe
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Emma Craythorne, MBChB FRCP contact
About this study
Official title: A Randomized Clinical Trial of Topical 2% Simvastatin Versus Vehicle for Xanthelasma Palpebrarum
This study is evaluating whether a topical cream containing 2% simvastatin can improve xanthelasma palpebrarum, a common condition that causes yellow cholesterol deposits on the eyelids. Current treatments such as surgery, laser therapy, and chemical treatments can be effective but may cause scarring, pigment changes, or recurrence.
In this randomized, double-blind, vehicle-controlled trial, 30 adults with xanthelasma will be assigned to receive either topical 2% simvastatin cream or an identical inactive vehicle cream for 24 weeks. Neither participants nor investigators will know which treatment is being used during this period. After 24 weeks, all participants will receive active simvastatin treatment for an additional 24 weeks in an open-label extension.
The study will assess changes in lesion size and appearance using standardized photography and measurements, as well as patient satisfaction, quality of life, and treatment tolerability. Results from this pilot study will help determine whether topical simvastatin may be a safe and effective non-invasive treatment option for xanthelasma and inform the design of larger future studies.
- Conditions
- Xanthelasma Palpebrarum
- Being tested
- Topical Simvastatin 2% Cream, Vehicle cream
- Keywords
- Xanthelasma Palpebrarum, Xanthelasma, Topical Simvastatin, Simvastatin, Topical Statin, Statin, Periocular Xanthoma, Eyelid Xanthoma, Randomized Controlled Trial, Double Blind Trial, Cosmetic Dermatology
- Medical subject headings
- Xanthomatosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Simvastatin 2% CreamDrug
Topical simvastatin 2% formulated in a high-viscosity periocular-safe cream base. Participants apply the cream once nightly to xanthelasma lesions for 24 weeks during the randomized double-blind phase. One pump delivers approximately 0.25 mL, sufficient to cover the index lesion, with any remaining product applied to additional lesions. Participants are instructed to avoid the lash line and conjunctiva. Following completion of the blinded phase, all participants receive active treatment during a 24-week open-label extension.
Vehicle creamOther
Identical high-viscosity periocular-safe cream base without active simvastatin. Applied once nightly to xanthelasma lesions during the 24-week randomized double-blind phase. The vehicle is matched to active treatment in appearance, packaging, labelling, and application instructions to maintain study blinding. Participants subsequently receive active topical simvastatin 2% cream during the open-label extension phase.
| Study group | Role | What they receive |
|---|---|---|
| Topical Simvastatin 2% Cream | Experimental | Participants receive topical simvastatin 2% cream applied once nightly to xanthelasma lesions for 24 weeks during the double-blind phase. Participants then continue active treatment during the 24-week open-label extension. Receives: Drug: Topical Simvastatin 2% Cream |
| Vehicle Cream | Placebo comparator | Participants receive an identical vehicle cream without active simvastatin applied once nightly for 24 weeks during the double-blind phase. Following completion of the blinded phase, participants receive topical simvastatin 2% cream during the 24-week open-label extension. Receives: Other: Vehicle cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change in Index Lesion Area
Percentage change in the area (mm²) of the predefined index xanthelasma lesion from baseline to Week 24, assessed using calibrated digital planimetry on standardized clinical photographs.
Measured: Baseline to Week 24
Secondary outcomes (6)
Percentage Change in Index Lesion Longest Diameter
Percentage change in the longest diameter (mm) of the predefined index xanthelasma lesion from baseline to Week 24, measured using standardized lesion measurements.
Measured: Baseline to Week 24
Change in Index Lesion Height
Change in height (mm) of the predefined index xanthelasma lesion from baseline to Week 24, measured using standardized lesion measurements where measurable.
Measured: Baseline to Week 24
Investigator Global Aesthetic Improvement Scale
Investigator-assessed aesthetic improvement of the index xanthelasma lesion at Week 24 using the Investigator Global Aesthetic Improvement Scale, assessed on standardized clinical photographs by a blinded clinician.
Measured: Week 24
Change in Dermatology Life Quality Index
Change in Dermatology Life Quality Index score from baseline to Week 24. The DLQI is a patient-reported dermatology-specific quality of life questionnaire scored from 0 to 30, with higher scores indicating greater impairment.
Measured: Baseline to Week 24
Change in Patient Satisfaction With Lesion Appearance
Change in patient-reported satisfaction with the appearance of the eyelid lesion from baseline to Week 24, assessed using a 0 to 10 numerical rating scale, where 0 indicates not at all satisfied and 10 indicates completely satisfied.
Measured: Baseline to Week 24
Patient Global Impression of Change
Patient-reported global impression of change in the eyelid lesion at Week 24 compared with baseline, assessed using an ordinal response scale ranging from very much improved to very much worse.
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Xanthelasma PalpebrarumStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klira Skin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07662785
- Sponsor's protocol ID
- 020/Ethics-IRB-REC/CoLDS-UoGM/
- Acronym
- STAT-LID
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The study team is considering future sharing of de-identified individual participant data. Any data sharing would be subject to participant confidentiality, applicable data protection regulations, and appropriate governance procedures.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of Topical 2% Simvastatin Versus Vehicle for Xanthelasma Palpebrarum
- ClinicalTrials.gov ID
- NCT07662785
- Acronym / sponsor ID
- STAT-LID / 020/Ethics-IRB-REC/CoLDS-UoGM/
- Conditions
- Xanthelasma Palpebrarum
- Keywords
- Xanthelasma Palpebrarum, Xanthelasma, Topical Simvastatin, Simvastatin, Topical Statin, Statin, Periocular Xanthoma, Eyelid Xanthoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Klira SkinUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 23 Jun 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.
This study is evaluating whether a topical cream containing 2% simvastatin can improve xanthelasma palpebrarum, a common condition that causes yellow cholesterol deposits on the eyelids. Current treatments such as surgery, laser therapy, and chemical treatments can be effective but may cause scarring, pigment changes, or recurrence.
In this randomized, double-blind, vehicle-controlled trial, 30 adults with xanthelasma will be assigned to receive either topical 2% simvastatin cream or an identical inactive vehicle cream for 24 weeks. Neither participants nor investigators will know which treatment is being used during this period. After 24 weeks, all participants will receive active simvastatin treatment for an additional 24 weeks in an open-label extension.
The study will assess changes in lesion size and appearance using standardized photography and measurements, as well as patient satisfaction, quality of life, and treatment tolerability. Results from this pilot study will help determine whether topical simvastatin may be a safe and effective non-invasive treatment option for xanthelasma and inform the design of larger future studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical Simvastatin 2% Cream | Experimental | Drug: Topical Simvastatin 2% CreamParticipants receive topical simvastatin 2% cream applied once nightly to xanthelasma lesions for 24 weeks during the double-blind phase. Participants then continue active treatment during the 24-week open-label extension. |
| Vehicle Cream | Placebo comparator | Other: Vehicle creamParticipants receive an identical vehicle cream without active simvastatin applied once nightly for 24 weeks during the double-blind phase. Following completion of the blinded phase, participants receive topical simvastatin 2% cream during the 24-week open-label extension. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or older
- Clinical diagnosis of xanthelasma palpebrarum confirmed by a study investigator
- At least one measurable periocular xanthelasma lesion
- No procedural treatment to the study lesion(s) within the past 3 months, including excision, laser, cryotherapy, chemical cautery/trichloroacetic acid, electrocautery, or radiofrequency
- Capacity to provide informed consent
Key exclusion criteria (8 listed)
- Known allergy or sensitivity to any study cream ingredient
- Active periocular inflammatory disease
- Use of topical eyelid treatments within the past 4 weeks, including topical corticosteroids, retinoids, acid peels, depigmenting agents, compounded creams, or over-the-counter eye creams containing active ingredients
- Pregnancy or breastfeeding
- Participation in another interventional clinical trial
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 Simvastatin 2% CreamTopical simvastatin 2% formulated in a high-viscosity periocular-safe cream base. Participants apply the cream once nightly to xanthelasma lesions for 24 weeks during the randomized double-blind phase. One pump delivers approximately 0.25 mL, sufficient to cover the index lesion, with any remaining product applied to additional lesions. Participants are instructed to avoid the lash line and conjunctiva. Following completion of the blinded phase, all participants receive active treatment during a 24-week open-label extension. | Drug | Topical Simvastatin 2% Cream |
| Vehicle creamIdentical high-viscosity periocular-safe cream base without active simvastatin. Applied once nightly to xanthelasma lesions during the 24-week randomized double-blind phase. The vehicle is matched to active treatment in appearance, packaging, labelling, and application instructions to maintain study blinding. Participants subsequently receive active topical simvastatin 2% cream during the open-label extension phase. | Other | Vehicle Cream |
Primary outcome
Percentage Change in Index Lesion Area
Time frame: Baseline to Week 24
Percentage change in the area (mm²) of the predefined index xanthelasma lesion from baseline to Week 24, assessed using calibrated digital planimetry on standardized clinical photographs.
6 secondary outcomes
Percentage Change in Index Lesion Longest Diameter
Time frame: Baseline to Week 24
Change in Index Lesion Height
Time frame: Baseline to Week 24
Investigator Global Aesthetic Improvement Scale
Time frame: Week 24
Change in Dermatology Life Quality Index
Time frame: Baseline to Week 24
Change in Patient Satisfaction With Lesion Appearance
Time frame: Baseline to Week 24
Patient Global Impression of Change
Time frame: Week 24
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 23 Jun 2026.
- Individual participant dataSharing planned: Undecided. The study team is considering future sharing of de-identified individual participant data. Any data sharing would be subject to participant confidentiality, applicable data protection regulations, and appropriate governance procedures.
Related trials for Xanthelasma Palpebrarum
Enrolling by invitation
Observation of the Effect and Mechanism of Multi Tunnel Minimally Invasive Treatment for Xanthelasma Palpebrarum
Xanthelasma Palpebrarum
Active, not recruiting
Efficacy of 100% Trichloroacetic Acid Vs. Cryotherapy in Xanthelasma Palpebrarum
Xanthelasma Palpebrarum
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.
Emma Craythorne, MBChB FRCP contact
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Topical Simvastatin 2% Cream in people with Xanthelasma Palpebrarum, run by Klira Skin.
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 8 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: opening soon, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Amber Khalil, MBChB (+447791731252, amberk@klira.skin), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Change in Index Lesion Area (time frame: Baseline to Week 24). 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 23 Jun 2026.