Acne VulgarisCER-S1P-ACNENCT07250880
Evaluation of Serum Ceramides C16, C24, and Sphingosine-1-Phosphate (S1P) in Patients With Acne Vulgaris
An observational study of Acne Vulgaris, run by Sohag University.
Trial summary
Acne vulgaris is a common chronic inflammatory skin disorder that affects adolescents and young adults. Recent research has shown that lipid mediators, including ceramides and sphingolipids, play an important role in maintaining skin barrier function and inflammation. Read more about this study
- Who is it for?
- Ages 15 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Blood sample collection for biochemical analysis of serum ceramides (C16, C24) and sphingosine-1-phosphate (S1P).
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Nov 2025to Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 15 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Study Population: A. Inclusion Criteria: For Case Group This group will consist of (40) patients : * Both males and females aged 15-40 years. * Mild, Moderate, severe and very severe cases will be included. 5 For Control Group: • This group will consist of age- and sex-matched (40) healthy volunteers. B. Exclusion Criteria (for both groups): * Presence of any dermatological condition other than acne vulgaris (for cases). * Use of systemic or topical treatment such as isotretinoin or antibiotics within the last 3 months. * Pregnancy or lactation. * History of lipid-lowering therapy or supplements affecting ceramide or sphingolipid metabolism
Who may be able to join
- For Case Group
- This group will consist of (40) patients :
- Both males and females aged 15-40 years.
- Mild, Moderate, severe and very severe cases will be included. 5
- For Control Group:
- This group will consist of age- and sex-matched (40) healthy volunteers.
Who cannot join
- Presence of any dermatological condition other than acne vulgaris (for cases).
- Use of systemic or topical treatment such as isotretinoin or antibiotics within the last 3 months.
- Pregnancy or lactation.
- History of lipid-lowering therapy or supplements affecting ceramide or sphingolipid metabolism.
About this study
Acne vulgaris is a common chronic inflammatory skin disorder that affects adolescents and young adults. Recent research has shown that lipid mediators, including ceramides and sphingolipids, play an important role in maintaining skin barrier function and inflammation.
This study aims to evaluate the serum levels of ceramide C16, ceramide C24, and sphingosine-1-phosphate (S1P) in patients with acne vulgaris and compare them to healthy controls. The goal is to explore their possible role in the pathogenesis and severity of acne. Blood samples will be collected from participants, and quantitative analysis will be performed using liquid chromatography-tandem mass spectrometry (LC-MS/MS).
Read the detailed description
Acne vulgaris involves complex biochemical and immunologic mechanisms that extend beyond the traditional concepts of follicular obstruction and increased sebum production. Emerging evidence highlights the contribution of systemic lipid mediators-particularly sphingolipids-in influencing keratinocyte behavior, sebaceous gland activity, and inflammatory signaling pathways. Disturbances in circulating ceramides and their downstream metabolites may reflect dysregulated lipid homeostasis that parallels the clinical manifestations of acne.
In this study, specific attention is given to three sphingolipid biomarkers that have been increasingly linked to cutaneous biology: Ceramide C16, Ceramide C24, and Sphingosine-1-phosphate (S1P). These molecules participate in cell differentiation, apoptosis, and immune responses, and their altered levels may provide insight into acne-related metabolic shifts. By quantitatively assessing their serum concentrations in affected individuals and comparing them with healthy subjects, the study aims to characterize potential biochemical patterns associated with disease presence and activity.
All biological samples will be processed using a validated LC-MS/MS analytical platform to ensure precise measurement of each sphingolipid species. The findings may help to clarify whether systemic sphingolipid disturbances contribute to acne pathophysiology and could support the development of lipid-based biomarkers or therapeutic strategies in future dermatologic research.
- Conditions
- Acne Vulgaris
- Being tested
- Blood sample collection for biochemical analysis of serum ceramides (C16, C24) and sphingosine-1-phosphate (S1P).
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample collection for biochemical analysis of serum ceramides (C16, C24) and sphingosine-1-phosphate (S1P).Other
Venous blood samples (5 mL) will be collected from all participants under aseptic conditions. Serum will be separated and stored at -80°C until analysis. Quantitative estimation of ceramide C16, ceramide C24, and sphingosine-1-phosphate (S1P) will be performed using liquid chromatography-tandem mass spectrometry (LC-MS/MS). No therapeutic intervention will be given.
| Study group | Role | What they receive |
|---|---|---|
| Acne vulgaris patients | Both males and females aged 15-40 years.
• Mild, Moderate, severe and very severe cases will be included Receives: Other: Blood sample collection for biochemical analysis of serum ceramides (C16, C24) and sphingosine-1-phosphate (S1P). | |
| Healthy controls | Healthy controls
Description:
Age- and sex-matched healthy volunteers Receives: Other: Blood sample collection for biochemical analysis of serum ceramides (C16, C24) and sphingosine-1-phosphate (S1P). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum levels of Ceramide C16, Ceramide C24, and Sphingosine-1-Phosphate (S1P)
Quantitative assessment of serum concentrations of Ceramide C16, Ceramide C24, and Sphingosine-1-Phosphate (S1P) in acne vulgaris patients and healthy controls using liquid chromatography-tandem mass spectrometry (LC-MS/MS).
Measured: At baseline (single visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study startNov 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalia Ahmed Helmy Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07250880
- Sponsor's protocol ID
- Soh-Med-25-10-11MS
- Acronym
- CER-S1P-ACNE
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Serum Ceramides C16, C24, and Sphingosine-1-Phosphate (S1P) in Patients With Acne Vulgaris
- ClinicalTrials.gov ID
- NCT07250880
- Acronym / sponsor ID
- CER-S1P-ACNE / Soh-Med-25-10-11MS
- Conditions
- Acne Vulgaris
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Nov 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 26 Nov 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.
Acne vulgaris is a common chronic inflammatory skin disorder that affects adolescents and young adults. Recent research has shown that lipid mediators, including ceramides and sphingolipids, play an important role in maintaining skin barrier function and inflammation.
This study aims to evaluate the serum levels of ceramide C16, ceramide C24, and sphingosine-1-phosphate (S1P) in patients with acne vulgaris and compare them to healthy controls. The goal is to explore their possible role in the pathogenesis and severity of acne. Blood samples will be collected from participants, and quantitative analysis will be performed using liquid chromatography-tandem mass spectrometry (LC-MS/MS).
Detailed description
Acne vulgaris involves complex biochemical and immunologic mechanisms that extend beyond the traditional concepts of follicular obstruction and increased sebum production. Emerging evidence highlights the contribution of systemic lipid mediators-particularly sphingolipids-in influencing keratinocyte behavior, sebaceous gland activity, and inflammatory signaling pathways. Disturbances in circulating ceramides and their downstream metabolites may reflect dysregulated lipid homeostasis that parallels the clinical manifestations of acne.
In this study, specific attention is given to three sphingolipid biomarkers that have been increasingly linked to cutaneous biology: Ceramide C16, Ceramide C24, and Sphingosine-1-phosphate (S1P). These molecules participate in cell differentiation, apoptosis, and immune responses, and their altered levels may provide insight into acne-related metabolic shifts. By quantitatively assessing their serum concentrations in affected individuals and comparing them with healthy subjects, the study aims to characterize potential biochemical patterns associated with disease presence and activity.
All biological samples will be processed using a validated LC-MS/MS analytical platform to ensure precise measurement of each sphingolipid species. The findings may help to clarify whether systemic sphingolipid disturbances contribute to acne pathophysiology and could support the development of lipid-based biomarkers or therapeutic strategies in future dermatologic research.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acne vulgaris patients | – | Other: Blood sample collection for biochemical analysis of serum ceramides (C16, C24) and sphingosine-1-phosphate (S1P).Both males and females aged 15-40 years. • Mild, Moderate, severe and very severe cases will be included |
| Healthy controls | – | Other: Blood sample collection for biochemical analysis of serum ceramides (C16, C24) and sphingosine-1-phosphate (S1P).Healthy controls Description: Age- and sex-matched healthy volunteers |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Study Population: A. Inclusion Criteria: For Case Group This group will consist of (40) patients : * Both males and females aged 15-40 years. * Mild, Moderate, severe and very severe cases will be included. 5 For Control Group: • This group will consist of age- and sex-matched (40) healthy volunteers. B. Exclusion Criteria (for both groups): * Presence of any dermatological condition other than acne vulgaris (for cases). * Use of systemic or topical treatment such as isotretinoin or antibiotics within the last 3 months. * Pregnancy or lactation. * History of lipid-lowering therapy or supplements affecting ceramide or sphingolipid metabolism
Key inclusion criteria (6 listed)
- For Case Group
- Both males and females aged 15-40 years.
- Mild, Moderate, severe and very severe cases will be included. 5
- This group will consist of age- and sex-matched (40) healthy volunteers.
Key exclusion criteria (4 listed)
- Presence of any dermatological condition other than acne vulgaris (for cases).
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 |
|---|---|---|
| Blood sample collection for biochemical analysis of serum ceramides (C16, C24) and sphingosine-1-phosphate (S1P).Venous blood samples (5 mL) will be collected from all participants under aseptic conditions. Serum will be separated and stored at -80°C until analysis. Quantitative estimation of ceramide C16, ceramide C24, and sphingosine-1-phosphate (S1P) will be performed using liquid chromatography-tandem mass spectrometry (LC-MS/MS). No therapeutic intervention will be given. | Other | Acne vulgaris patients, Healthy controls |
Primary outcome
Serum levels of Ceramide C16, Ceramide C24, and Sphingosine-1-Phosphate (S1P)
Time frame: At baseline (single visit)
Quantitative assessment of serum concentrations of Ceramide C16, Ceramide C24, and Sphingosine-1-Phosphate (S1P) in acne vulgaris patients and healthy controls using liquid chromatography-tandem mass spectrometry (LC-MS/MS).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acne Vulgaris, run by Sohag University.
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 6 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: opening soon, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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 levels of Ceramide C16, Ceramide C24, and Sphingosine-1-Phosphate (S1P) (time frame: At baseline (single visit)). 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 26 Nov 2025.