Acne VulgarisNCT04056598
Acne Vulgaris Related Microbiology and Serology
An observational study of Acne Vulgaris, run by Sanofi at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Study of humoral immunity
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2018to 30 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Subjects for the study will be drawn from: * Study group: Acne patients, 18-40 years of age, currently suffering from moderate or severe acne vulgaris * Control group: Healthy individuals of 18-40 years of age, who recovered from moderate or severe acne vulgaris
Who may be able to join
- Acne patients (18 - 40 years of age)
- Clinical diagnosis of medium acne vulgaris (covering more than 30% of the patient's face and loaded with comedones, pustules and acne lesions of >2 cm in size) for at least six months or longer
- Clinical diagnosis of severe acne vulgaris (acne conglobata, sinus or cystic type acne covering most of the face (>60% of the facial surface) - IGA 3-4) for at least six months or longer
- Age-matched healthy adults (between 18 and 40 years), with history of moderate or severe acne, but who have been free from acne for more than two years - 'free from acne' period may include minor, intermittent breakouts due to hormonal reasons, such as menstruation
Who cannot join
- Subjects who received anti-acne antibiotic therapy less than 2 months prior to recruitment
- Subjects who received isotretinoin therapy within the last 6 months
- Subjects who were using hormonal contraceptives within the last 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Research Associates of Tidewater
Norfolk, Virginia, 23507
About this study
Official title: Characterization of Immune Responses Against Acne-associated Bacterium Propionibacterium Acnes - a Pilot Study
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.
Read the detailed 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:
- Immunogenicity of P. acnes in the acne patients compared to healthy individuals who are recovered from moderate or severe acne vulgaris.
- The role of antibodies in controlling colonization and acne development due to P. acnes
- 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.
- Conditions
- Acne Vulgaris
- Being tested
- Study of humoral immunity
- Keywords
- P. acnes, acne vulgaris, humoral immune response, microbiome, SLST
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study of humoral immunityDiagnostic test
Also called Study of skin microbiome
Analysis: Surface antigen ELISA, recognition of living P. acnes bacteria via FACS, 16SRNA study of microbiome, SLST typing of P. acnes bacteria
| Study group | Role | What they receive |
|---|---|---|
| Moderate to severe acne vulgaris | Determined by the acne severity grade of IGA 2 and above Receives: Diagnostic Test: Study of humoral immunity | |
| Mild acne vulgaris | Determined by the severity grade of IGA <2 Receives: Diagnostic Test: Study of humoral immunity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Secondary outcomes (1)
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start18 Jan 2018
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
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 SanofiThe 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
- Cohort
- Time perspective
- Other
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CRAT
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04056598
- Sponsor's protocol ID
- SAIRB-17-0087
- Status last verified
- Jan 2021
- First submitted
- 5 Aug 2019
- Last updated
- 6 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Immune Responses Against Acne-associated Bacterium Propionibacterium Acnes - a Pilot Study
- ClinicalTrials.gov ID
- NCT04056598
- Acronym / sponsor ID
- SAIRB-17-0087
- Conditions
- Acne Vulgaris
- Keywords
- P. acnes, acne vulgaris, humoral immune response, microbiome, SLST
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- CRAT
- Study start
- 18 Jan 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 14 Aug 2019 (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.
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.
Detailed 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:
- Immunogenicity of P. acnes in the acne patients compared to healthy individuals who are recovered from moderate or severe acne vulgaris.
- The role of antibodies in controlling colonization and acne development due to P. acnes
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate to severe acne vulgaris | – | Diagnostic Test: Study of humoral immunityDetermined by the acne severity grade of IGA 2 and above |
| Mild acne vulgaris | – | Diagnostic Test: Study of humoral immunityDetermined by the severity grade of IGA <2 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Subjects for the study will be drawn from: * Study group: Acne patients, 18-40 years of age, currently suffering from moderate or severe acne vulgaris * Control group: Healthy individuals of 18-40 years of age, who recovered from moderate or severe acne vulgaris
Key inclusion criteria (4 listed)
- Acne patients (18 - 40 years of age)
- Clinical diagnosis of medium acne vulgaris (covering more than 30% of the patient's face and loaded with comedones, pustules and acne lesions of >2 cm in size) for at least six months or longer
- Clinical diagnosis of severe acne vulgaris (acne conglobata, sinus or cystic type acne covering most of the face (>60% of the facial surface) - IGA 3-4) for at least six months or longer
- Age-matched healthy adults (between 18 and 40 years), with history of moderate or severe acne, but who have been free from acne for more than two years - 'free from acne' period may include minor, intermittent breakouts due to hormonal reasons, such as menstruation
Key exclusion criteria (3 listed)
- Subjects who received anti-acne antibiotic therapy less than 2 months prior to recruitment
- Subjects who received isotretinoin therapy within the last 6 months
- Subjects who were using hormonal contraceptives within the last 3 months
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 |
|---|---|---|
| Study of humoral immunityAlso: Study of skin microbiomeAnalysis: Surface antigen ELISA, recognition of living P. acnes bacteria via FACS, 16SRNA study of microbiome, SLST typing of P. acnes bacteria | Diagnostic test | Mild acne vulgaris, Moderate to severe acne vulgaris |
Primary outcome
Correlation of acne vulgaris severity with humoral immunity assessed by ELISA, binding to P. acnes strains and OPK assay
Time frame: 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.
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
Correlation of acne vulgaris severity with skin microbiome identified in acne lesions and by facial swabs
Time frame: 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.
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
1 secondary outcome
Correlation of microbiome identified on skin and acne lesion samples (Outcome 2) with humoral immunity (Outcome 1)
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acne Vulgaris, run by Sanofi at 1 site in United States.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Correlation of acne vulgaris severity with humoral immunity assessed by ELISA, binding to P. acnes strains and OPK assay (time frame: 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.). The study lists 2 primary outcomes in all. 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 6 Jan 2021.