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NCT Number: NCT07250880

Evaluation of Serum Ceramides C16, C24, and Sphingosine-1-Phosphate (S1P) in Patients With Acne Vulgaris

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).

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Key information

Age range

15 year–40 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Acronym: CER-S1P-ACNE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 26, 2025
Registry last updated
Nov 26, 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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