NCT04056598

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 18, 2018

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 14, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

January 6, 2021

Status Verified

January 1, 2021

Enrollment Period

1.7 years

First QC Date

August 5, 2019

Last Update Submit

January 5, 2021

Conditions

Acne Vulgaris

Keywords

P. acnesacne vulgarishumoral immune responsemicrobiomeSLST

Outcome Measures

Primary Outcomes (2)

  • 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.

Secondary Outcomes (1)

  • Correlation of microbiome identified on skin and acne lesion samples (Outcome 2) with humoral immunity (Outcome 1)

    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.

Study Arms (2)

Moderate to severe acne vulgaris

Determined by the acne severity grade of IGA 2 and above

Diagnostic Test: Study of humoral immunity

Mild acne vulgaris

Determined by the severity grade of IGA \<2

Diagnostic Test: Study of humoral immunity

Interventions

Study of humoral immunityDIAGNOSTIC_TEST

Analysis: Surface antigen ELISA, recognition of living P. acnes bacteria via FACS, 16SRNA study of microbiome, SLST typing of P. acnes bacteria

Also known as: Study of skin microbiome
Mild acne vulgarisModerate to severe acne vulgaris

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Associates of Tidewater

Norfolk, Virginia, 23507, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Patient serum samples and facial swabs for microbiome analysis

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2019

First Posted

August 14, 2019

Study Start

January 18, 2018

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

January 6, 2021

Record last verified: 2021-01

Locations

US(1)