AcneNCT01929057
Evaluation of the Role of Propionibacterium Acnes in the Inflammatory Lesions Associated With Acne Vulgaris
An observational study of Acne, run by University of California, San Diego at 1 site in United States.
Trial summary
The purpose of this study is to determine the response of acne patients and healthy control patients to the P. acnes bacteria. Half a tube of blood will be drawn from all participants to determine whether or not they have antibodies to the P. acnes bacterium. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne
- What is being tested?
- Skin biopsy and Blood draw
- Type of treatment
- Surgery or procedure
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Jun 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: community sample
Who may be able to join
- Fits into one of the following diagnostic groups:
- Healthy subject with no active skin disease or history of skin disease
- Diagnosis of moderate-to-severe truncal acne diagnosed clinically and confirmed using the modified Leeds criteria with no reported use of topical acne treatments within the past 2 weeks prior to enrollment in the study, and no reported use of oral acne treatments during the past 4 weeks prior to enrollment in the study
- Diagnosis of moderate-to-severe truncal acne diagnosed clinically and confirmed using the modified Leeds criteria who has used any topical acne treatments in the 2 weeks prior to enrolling in the study, or who has used any oral acne treatments during the 4 weeks prior to enrolling in the study 2. Age 18-60 years 3. Male or female of any race and ethnicity 4. Subject agrees to comply with study requirements
Who cannot join
- Subjects with severe medical condition(s) that in the view of the investigator prohibits participation in the study
- Subject has Netherton's syndrome or other genodermatoses that result in a defective epidermal barrier
- Pregnant or nursing females
- Immunocompromised subjects (e.g., lymphoma, HIV/AIDS, Wiskott-Aldrich Syndrome), or with a history of active or malignant disease (excluding non-melanoma skin cancer) as determined by the participant's medical history.
- Subjects with a history of psychiatric disease or history of alcohol or drug abuse that would interfere with the ability to comply with the study protocol
- Subjects with significant concurrent medical condition(s) at screening that in the view of the investigator prohibits participation in the study (e.g., severe concurrent allergic disease, condition associated with malignancy, and condition associated with immunosuppression)
Show all 13Show fewer
- Active viral or fungal skin infections at the target areas
- Are currently receiving lithium now or within the last 4 weeks.
- Ongoing participation in an investigational drug trial
- Use of any systemic immunosuppressive therapy less than four weeks prior to screening.
- Subjects with diabetes
- Injured, broken skin that, per the investigator, may lead to poor wound healing
- Subjects with allergies to anesthetic medications
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSD Division of Dermatology
San Diego, California, 92122
About this study
The purpose of this study is to determine the response of acne patients and healthy control patients to the P. acnes bacteria. Half a tube of blood will be drawn from all participants to determine whether or not they have antibodies to the P. acnes bacterium. Anywhere from 1 to 4 skin biopsies of acne pimples or normal control skin will be taken from all subjects for further analysis in the lab to determine whether the inflammation in these pimples can be reduced using anti-P.acnes antibodies.
- Conditions
- Acne
- Being tested
- Skin biopsy, Blood draw
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin biopsyProcedure or surgery
4-millimeter punch biopsies will be performed on all subjects (acne patients and healthy controls)
Blood drawProcedure or surgery
Approximately half a tube of blood will be drawn from all participants in the study
| Study group | Role | What they receive |
|---|---|---|
| Acne patients | This group consists of patients who have at least moderate to severe acne on their back Receives: Procedure: Skin biopsy; Procedure: Blood draw | |
| Healthy Controls | This group contains participants who do not have any active acne lesions on their back Receives: Procedure: Skin biopsy; Procedure: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of IL-1β
The amount of IL-1β, an inflammatory marker, is measured in skin biopsies obtained from healthy patients and compared with levels in biopsies of acne lesions.
Measured: post biopsy
Secondary outcomes (1)
Level of Antibody to CAMP(Christie-Atkins-Munch-Petersen) Factor
Antibody titers were determined by using recombinant CAMP factor or green fluorescent protein (GFP) as a capture antigen for coating onto a enzyme-linked immunosorbent assay (ELISA) plate. The endpoint was defined as the dilution of serum on CAMP factor-coated wells producing the same Optical Density(570-450) as a 1/100 dilution of serum on GFP-coated wells. Sera negative at the lowest dilution tested were assigned endpoint titers of 100. The data were presented as geometric mean endpoint ELISA titers.
Measured: post biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AcneStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Cross-sectional
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tissa Hata, MD, University of California, San Diego
- Investigators
- Tissa Hata, MD, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01929057
- Sponsor's protocol ID
- 121230
- Status last verified
- Oct 2019
- First submitted
- 21 Aug 2013
- Last updated
- 3 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Role of Propionibacterium Acnes in the Inflammatory Lesions Associated With Acne Vulgaris
- ClinicalTrials.gov ID
- NCT01929057
- Acronym / sponsor ID
- 121230
- Conditions
- Acne
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 27 Aug 2013 (estimated)
- Results
- Posted 3 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the response of acne patients and healthy control patients to the P. acnes bacteria. Half a tube of blood will be drawn from all participants to determine whether or not they have antibodies to the P. acnes bacterium. Anywhere from 1 to 4 skin biopsies of acne pimples or normal control skin will be taken from all subjects for further analysis in the lab to determine whether the inflammation in these pimples can be reduced using anti-P.acnes antibodies.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acne patients | – | Procedure: Skin biopsy, Procedure: Blood drawThis group consists of patients who have at least moderate to severe acne on their back |
| Healthy Controls | – | Procedure: Skin biopsy, Procedure: Blood drawThis group contains participants who do not have any active acne lesions on their back |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- community sample
Key inclusion criteria (4 listed)
- Fits into one of the following diagnostic groups:
Key exclusion criteria (13 listed)
- Subjects with severe medical condition(s) that in the view of the investigator prohibits participation in the study
- Subject has Netherton's syndrome or other genodermatoses that result in a defective epidermal barrier
- Pregnant or nursing females
- Immunocompromised subjects (e.g., lymphoma, HIV/AIDS, Wiskott-Aldrich Syndrome), or with a history of active or malignant disease (excluding non-melanoma skin cancer) as determined by the participant's medical history.
- Subjects with a history of psychiatric disease or history of alcohol or drug abuse that would interfere with the ability to comply with the study protocol
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 |
|---|---|---|
| Skin biopsy4-millimeter punch biopsies will be performed on all subjects (acne patients and healthy controls) | Procedure or surgery | Acne patients, Healthy Controls |
| Blood drawApproximately half a tube of blood will be drawn from all participants in the study | Procedure or surgery | Acne patients, Healthy Controls |
Primary outcome
Level of IL-1β
Time frame: post biopsy
The amount of IL-1β, an inflammatory marker, is measured in skin biopsies obtained from healthy patients and compared with levels in biopsies of acne lesions.
1 secondary outcome
Level of Antibody to CAMP(Christie-Atkins-Munch-Petersen) Factor
Time frame: post biopsy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Tissa Hata, MD principal investigator
UCSD
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, run by University of California, San Diego 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 13 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 3 Oct 2019. 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?
Yes. Results are posted in the registry (first posted 3 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Level of IL-1β (time frame: post biopsy). 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 3 Oct 2019.