Seborrheic Keratosis (SK)SK-XONCT07095348
Relationship Between Serum Xanthine Oxidase Levels and Seborrheic Keratosis
An observational study of Seborrheic Keratosis (SK) and Oxidative Stress, run by Sri Nauli Dewi Lubis at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Seborrheic Keratosis (SK), Oxidative Stress, Skin Aging
- What is being tested?
- Serum Xanthine Oxidase Level Assessment
- How many people
- 80 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Oct 2023to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Prof. dr. Chairuddin Panusunan Lubis Universitas Sumatera Utara Hospital
Medan, North Sumatra, 20155
About this study
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.
Read the detailed description
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.
- Conditions
- Seborrheic Keratosis (SK), Oxidative Stress, Skin Aging
- Being tested
- Serum Xanthine Oxidase Level Assessment
- Keywords
- Xanthine Oxidase, Reactive Oxygen Species, Skin Lesions, Benign Skin Tumor, Dermatology, Facial Hyperpigmentation, ELISA, Cross-Sectional Study, UV Exposure, Guanine Deaminase
- Medical subject headings
- Keratosis, Seborrheic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum Xanthine Oxidase Level AssessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Serum Xanthine Oxidase Level Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Single measurement during study visit (cross-sectional)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start1 Oct 2023
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seborrheic Keratosis (SK)Studies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sri Nauli Dewi Lubis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sri Nauli Dewi Lubis, Universitas Sumatera Utara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07095348
- Sponsor's protocol ID
- SK-XO-2024-USU
- Acronym
- SK-XO
- Status last verified
- Jul 2025
- First submitted
- 16 Jul 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) related to serum xanthine oxidase (XO) levels, age, sex, and occupational category will be shared. No personally identifiable information will be included.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Serum Xanthine Oxidase Levels and Seborrheic Keratosis
- ClinicalTrials.gov ID
- NCT07095348
- Acronym / sponsor ID
- SK-XO / SK-XO-2024-USU
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Sri Nauli Dewi LubisUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 31 Jul 2025 (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 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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Seborrheic Keratosis Group | – | Other: Serum Xanthine Oxidase Level AssessmentThis 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. |
| Control Group | – | Other: Serum Xanthine Oxidase Level AssessmentThis 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Serum Xanthine Oxidase Level AssessmentBlood 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. | Other | Control Group, Seborrheic Keratosis Group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) related to serum xanthine oxidase (XO) levels, age, sex, and occupational category will be shared. No personally identifiable information will be included.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Seborrheic Keratosis (SK) and Oxidative Stress, run by Sri Nauli Dewi Lubis at 1 site in Indonesia.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Xanthine Oxidase Concentration Measured by ELISA in Patients With and Without Seborrheic Keratosis (time frame: Single measurement during study visit (cross-sectional)). 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 31 Jul 2025; AzTrials last refreshed its copy on 8 Nov 2026.