Relationship Between Serum Xanthine Oxidase Levels and Seborrheic Keratosis
NCT ID: NCT07095348
Last Updated: 2025-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
80 participants
OBSERVATIONAL
2023-10-01
2024-06-30
Brief Summary
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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.
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Detailed Description
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This observational study is designed to investigate the potential association between serum xanthine oxidase (XO) levels and the presence of SK. XO is a pro-oxidant enzyme involved in purine metabolism that generates reactive oxygen species (ROS), including superoxide and hydrogen peroxide. These ROS may play a role in oxidative stress, which is thought to contribute to various skin aging processes and possibly to benign epidermal proliferative conditions like SK.
A total of 80 participants are included in the study: 40 patients diagnosed with SK and 40 healthy controls without SK. Participants are between 18 and 50 years old and recruited from the dermatology outpatient clinic. All subjects undergo clinical and dermoscopic examination for confirmation of diagnosis. Blood samples are collected from all participants, and serum XO levels are measured using a validated enzyme-linked immunosorbent assay (ELISA) technique.
Strict inclusion and exclusion criteria are applied to minimize confounding variables, such as the presence of other dermatologic conditions, systemic illnesses, or recent antioxidant treatment. This protocol is aimed at providing foundational data to explore the biochemical basis of SK and the potential involvement of oxidative mechanisms.
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Seborrheic Keratosis Group
This group includes 40 participants diagnosed with seborrheic keratosis through clinical and dermoscopic examination. Venous blood was collected to measure serum xanthine oxidase (XO) levels using ELISA. Participants were between 18 and 50 years old and had no underlying systemic diseases. This group represents the case population in this observational case-control study.
Serum Xanthine Oxidase Level Assessment
Blood samples were collected from each participant and serum was separated by centrifugation. Serum xanthine oxidase (XO) levels were measured using a Human XO ELISA Kit (Cat No. E3495Hu) according to the manufacturer's instructions. This intervention involved no therapeutic intent and was performed for observational biomarker analysis only.
Control Group
This group includes 40 healthy participants without seborrheic keratosis or other hyperpigmented skin lesions. They were age- and sex-matched to the case group. Blood samples were collected to determine serum XO levels using the same ELISA protocol. These individuals served as the control group for comparison of XO levels.
Serum Xanthine Oxidase Level Assessment
Blood samples were collected from each participant and serum was separated by centrifugation. Serum xanthine oxidase (XO) levels were measured using a Human XO ELISA Kit (Cat No. E3495Hu) according to the manufacturer's instructions. This intervention involved no therapeutic intent and was performed for observational biomarker analysis only.
Interventions
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Serum Xanthine Oxidase Level Assessment
Blood samples were collected from each participant and serum was separated by centrifugation. Serum xanthine oxidase (XO) levels were measured using a Human XO ELISA Kit (Cat No. E3495Hu) according to the manufacturer's instructions. This intervention involved no therapeutic intent and was performed for observational biomarker analysis only.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
50 Years
ALL
Yes
Sponsors
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Sri Nauli Dewi Lubis
OTHER
Responsible Party
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Sri Nauli Dewi Lubis
Universitas Sumatera Utara
Locations
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Prof. dr. Chairuddin Panusunan Lubis Universitas Sumatera Utara Hospital
Medan, North Sumatra, Indonesia
Countries
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Other Identifiers
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SK-XO-2024-USU
Identifier Type: -
Identifier Source: org_study_id
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