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| Name | Class |
|---|---|
| CRAT | UNKNOWN |
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This will be an investigation to determine the quality of the serological immune responses against Propionibacterium acnes (P. acnes) in acne patients compared to healthy individuals. In particular, the investigators will measure serum antibody titers against P. acnes surface antigens, and the efficiency of antibody-mediated phagocytic killing of P. acnes.
Acne vulgaris, which affects >85% of teenagers and >10% of adults, was recently re-defined as a complex chronic disease associated with Propionibacterium acnes (P. acnes). Until recently, the pathogenic role of bacteria Propionibacterium acnes (P. acnes) has been debated due to the fact that this bacterium is also found, although in lower density, on the skin of healthy individuals. However, in the last few years, genomic sequencing and the comparative analysis of >250 P. acnes strains revealed the existence of the strains prevalently associated with severe cases of acne. In the study that analyzed more than 200 clinical isolates, it was found that 75% of the P. acnes strains that were isolated from acne lesions of acne patients, belonged to genetic type I-IA and that this group also represented 85% of the antibiotic resistant P. acnes strains isolated in the course of the study. This provided the first clear evidence for the virulent potential of P. acnes, that has been previously suspected also in some cases of eye, bone and post-operative infections. More recent research studies have identified additional virulent strains which can be distinguished based on the ribosomal DNA analysis.
Although these genetic studies have revealed the existence of virulent P. acnes strains, it is not yet clear how these strains promote disease pathogenesis and symptoms, and whether the host immune response either exaggerates or ameliorates the disease. In particular, there have been no systematic studies regarding the role of a central immunity in the protection against this pathogen.
Therefore, this will be one of the first studies to address scientifically and therapeutically important questions including:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate to severe acne vulgaris | Determined by the acne severity grade of IGA 2 and above |
| |
| Mild acne vulgaris | Determined by the severity grade of IGA <2 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Study of humoral immunity | Diagnostic Test | Analysis: Surface antigen ELISA, recognition of living P. acnes bacteria via FACS, 16SRNA study of microbiome, SLST typing of P. acnes bacteria |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of acne vulgaris severity with humoral immunity assessed by ELISA, binding to P. acnes strains and OPK assay | Quantitative and qualitative investigation of serum immuno globulins by (1) P. acnes surface antigen specific ELISA (EC50), (2) FACS binding (MFI) analysis on living P. acnes microorganisms of the most relevant SLST's and (3) opsono-phagocytotic killing potency (% killing) on the most important P. acnes strains in presence of human effector cells | Serum samples will be collected at visit and samples will be investigated upon availability of all samples. Analysis will occur an average of 1 year and will reflect patient's immune status at visit. |
| Correlation of acne vulgaris severity with skin microbiome identified in acne lesions and by facial swabs | Swabs from skin (cheak and front head) and acne lesions (pustules) will be collected and microbiome (presence of specific microorganism) will be analyzed by NGS. SLST (SLST typing) will be applied to characterize in detail identified P. acnes strains | Swabs will be collected at visit and samples will be investigated upon availability of all samples. Analysis will be done an average of 1 year and will reflect patient's microbiome (on skin and in acne lesions) at visit. |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of microbiome identified on skin and acne lesion samples (Outcome 2) with humoral immunity (Outcome 1) | We will investigate a potential correlation between results from assessment of humoral immunity (Outcome 1) and patient specific microbiome identified in skin lesions and on the skin. | Serum and microbiome samples will be collected at patient's visit. Analysis will be done an average of 1 year and will reflect patient status at visit. |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects for the study will be drawn from:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Associates of Tidewater | Norfolk | Virginia | 23507 | United States |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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Patient serum samples and facial swabs for microbiome analysis
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