Relationship Between Serum Xanthine Oxidase Levels and Seborrheic Keratosis

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.

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Key information

Conditions

Seborrheic Keratosis (SK) Keratosis Keratosis, Seborrheic Oxidative Stress Skin Aging Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Prof. dr. Chairuddin Panusunan Lubis Universitas Sumatera Utara Hospital

Medan, North Sumatra, 20155, Indonesia

About this study

Seborrheic keratosis (SK) is one of the most common benign skin tumors observed in dermatology practice. Although SK is not malignant, its appearance can be concerning to patients, particularly when lesions are numerous or located on visible areas such as the face. The exact cause of SK is unknown, but multiple factors such as age, genetics, ultraviolet (UV) exposure, and oxidative stress have been implicated.

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Serum Xanthine Oxidase Level Assessment

Other

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.

Primary outcomes

Serum Xanthine Oxidase Concentration Measured by ELISA in Patients With and Without Seborrheic Keratosis

Time frame: Single measurement during study visit (cross-sectional)

This outcome measures the serum concentration of xanthine oxidase (XO) using a Human Xanthine Oxidase ELISA Kit (Cat. No E3495Hu) in participants aged 18-50 years. The concentration is expressed in ng/mL. Blood samples are collected from both seborrheic keratosis (SK) patients and healthy control participants.

Sponsors and collaborators

Lead sponsor

Sri Nauli Dewi Lubis

Other

Registry information

Acronym: SK-XO

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Jul 31, 2025
Registry last updated: Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed