Acne Vulgaris Related Microbiology and Serology (NCT04056598) | Clinical Trial Compass
CompletedNot Applicable
Acne Vulgaris Related Microbiology and Serology
United States120 participantsStarted 2018-01-18
Plain-language 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.
Who can participate
Age range
18 Years – 40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Correlation of acne vulgaris severity with humoral immunity assessed by ELISA, binding to P. acnes strains and OPK assay
Timeframe: 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.
2
Correlation of acne vulgaris severity with skin microbiome identified in acne lesions and by facial swabs
Timeframe: 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.