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

NCT ID: NCT07250880

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2026-09-30

Brief 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.

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.

Conditions

Acne Vulgaris

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Acne vulgaris patients

Both males and females aged 15-40 years.

• Mild, Moderate, severe and very severe cases will be included

Blood sample collection for biochemical analysis of serum ceramides (C16, C24) and sphingosine-1-phosphate (S1P).

Intervention Type: 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.

Healthy controls

Healthy controls

Description:

Age- and sex-matched healthy volunteers

Blood sample collection for biochemical analysis of serum ceramides (C16, C24) and sphingosine-1-phosphate (S1P).

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Dalia Ahmed Helmy Ahmed

Dermatology Resident At Albalyna central hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

Soh-Med-25-10-11MS

Identifier Type: -

Identifier Source: org_study_id