Relationship Between Serum Xanthine Oxidase Levels and Seborrheic Keratosis

NCT07095348 | Completed

• 1 other identifier: SK-XO-2024-USU
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Seborrheic Keratosis (SK); Oxidative Stress; Skin Aging

Keywords

Xanthine Oxidase; Reactive Oxygen Species; Skin Lesions; Benign Skin Tumor; Dermatology; Facial Hyperpigmentation; ELISA; Cross-Sectional Study; UV Exposure; Guanine Deaminase

Outcome Measures

Primary Outcomes (1)

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

  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.

  Single measurement during study visit (cross-sectional)

Study Arms (2)

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.

Other: Serum Xanthine Oxidase Level Assessment

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.

Other: Serum Xanthine Oxidase Level Assessment

Interventions

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.

Control Group; Seborrheic Keratosis Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants aged 18 to 50 years recruited from the dermatology outpatient clinic, including patients with seborrheic keratosis and healthy individuals without skin lesions.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sri Nauli Dewi Lubis: lead

Study Sites (1)

Prof. dr. Chairuddin Panusunan Lubis Universitas Sumatera Utara Hospital

Medan, North Sumatra, 20155, Indonesia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples were collected from venous blood of all participants to measure xanthine oxidase (XO) levels. Blood was drawn, allowed to clot, and then centrifuged to obtain the serum. The serum samples were analyzed using a Human Xanthine Oxidase ELISA Kit. No DNA was extracted, and no genetic testing was performed.

MeSH Terms

Conditions

Keratosis, Seborrheic

Condition Hierarchy (Ancestors)

Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Universitas Sumatera Utara

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: July 31, 2025
• Study Start: October 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data and supporting documents will be available starting January 1, 2026, for a period of 5 years or upon reasonable request while the study findings remain relevant.
• Access Criteria: Qualified researchers affiliated with academic or research institutions may request access to the data by contacting the corresponding author. Requests must include a brief research proposal and intended use. Access will be granted via secure data transfer following ethics committee review if necessary.

Locations

ID (1)