Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04056598 |
| Other study ID # |
SAIRB-17-0087 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 18, 2018 |
| Est. completion date |
September 30, 2019 |
Study information
| Verified date |
January 2021 |
| Source |
Origimm Biotechnology GmbH |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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.
Description:
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:
1. Immunogenicity of P. acnes in the acne patients compared to healthy individuals who are
recovered from moderate or severe acne vulgaris.
2. The role of antibodies in controlling colonization and acne development due to P. acnes
3. The relationship between P. acnes genetic information and serotype classification, based
on the immune recognition pattern (the degree of the similarity among genetically
different strains based on the surface components recognition by the immune system)
Answering these questions could support development of novel and better treatment
options, which could significantly improve the outcome in acne vulgaris patients.
Existing acne treatments either treat the symptoms only on skin surface (e.g. topical
agents: creams, lotions), or are not offering long-term solutions (antibiotics, vitamin
A derivatives). Moreover, antibiotics raise antibiotic resistance among P. acnes as well
as other types of bacteria and increase the risk of super-infection by other pathogens.
Vitamin A derivatives are not effective in all patients and post-therapy relapse is
common; besides, they are not routinely prescribed to patients due to serious side
effects.
