Relationship Between Serum Xanthine Oxidase Levels and Seborrheic Keratosis (NCT07095348) | Clinical Trial Compass
CompletedNot Applicable
Relationship Between Serum Xanthine Oxidase Levels and Seborrheic Keratosis
Indonesia80 participantsStarted 2023-10-01
Plain-language summary
This observational study aims to examine the relationship between serum xanthine oxidase (XO) levels and seborrheic keratosis (SK), a common benign skin tumor, especially in middle-aged and older adults. The pathogenesis of SK remains unclear, but oxidative stress is believed to play a role. XO is an enzyme that contributes to the production of reactive oxygen species (ROS), which can cause oxidative damage in the skin.
A total of 80 participants will be included in the study, consisting of 40 patients diagnosed with SK and 40 healthy individuals as controls. Each participant will undergo clinical and dermoscopic examination, followed by blood sampling to measure serum XO levels using ELISA. The study will be conducted at the Dermatology and Venereology Clinic of Prof. dr. Chairuddin Panusunan Lubis Universitas Sumatera Utara Hospital from October 2023 to June 2024.
This study has been reviewed and approved by the Ethics Committee of the Faculty of Medicine, Universitas Sumatera Utara.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged 18 to 50 years
* Willing to participate and sign informed consent
* Able to undergo dermatologic and dermoscopic examination
* For case group: diagnosed with seborrheic keratosis
* For control group: no clinical or dermoscopic evidence of seborrheic keratosis
Exclusion Criteria:
* History or presence of other hyperpigmentation skin lesions (e.g., lentigo solaris)
* Diagnosed with systemic diseases such as diabetes mellitus, cardiovascular disease, hepatitis, HIV/AIDS, gout, or renal impairment
* Taking medications that affect oxidative stress biomarkers
* Pregnant or breastfeeding women
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Serum Xanthine Oxidase Concentration Measured by ELISA in Patients With and Without Seborrheic Keratosis
Timeframe: Single measurement during study visit (cross-sectional)