Acne VulgarisNCT03818555
Sebacia Postmarket Study of Real-World Use
A study testing Sebacia Microparticles Treatment in people with Acne Vulgaris, run by Sebacia, Inc. at 6 sites in United States.
Trial summary
Postmarket study of Sebacia Microparticles treatment during adoption into clinical use for patients with mild to moderate inflammatory acne vulgaris. Read more about this study
- Who is it for?
- Ages 12 to 45 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Sebacia Microparticles Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 Jan 2019to Jun 2021
- Phase
- Interventional
- 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 12 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Mild to moderate facial inflammatory acne vulgaris (IGA 2 or 3)
- Between 10 and 50 papules/pustules
- Fitzpatrick skin phototype I, II or III
- Able to provide informed consent and comply with study schedule and other requirements
Who cannot join
- Moderately severe or severe acne vulgaris (IGA 4 or 5)
- Nodulocystic acne, significant scarring or excoriation
- Requires oral retinoid, antibiotic or corticosteroid for acne
- New or fluctuating hormone or hormone-regulating therapy
- Photosensitivity or allergy to gold
- Medical or mental health condition that would pose a risk to patient or impair treatment and evaluation
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Austin Institute for Clinical Research - Central
Austin, Texas, 78705
Dermatology Institute of Boston
Boston, Massachusetts, 02116
Miami Dermatology & Laser Institute
Miami, Florida, 33173
International Clinical Research
Murfreesboro, Tennessee, 37130
Austin Institute for Clinical Research - Pflugerville
Pflugerville, Texas, 78660
Premier Clinical Research
Spokane, Washington, 99202
About this study
Official title: A Prospective, Multicenter, Postmarket Study of Sebacia Microparticles Treatment in Patients Using Topical Acne Products for Mild to Moderate Inflammatory Acne Vulgaris
Postmarket study of Sebacia Microparticles treatment during adoption into clinical use for patients with mild to moderate inflammatory acne vulgaris.
- Conditions
- Acne Vulgaris
- Being tested
- Sebacia Microparticles Treatment
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sebacia Microparticles TreatmentOther
Also called Sebacia treatment, Microparticles and Nd:Yag laser treatment
Sebacia Microparticles procedure involving microparticles and 1064 nm laser. Three treatment procedures over a two-week period.
| Study group | Role | What they receive |
|---|---|---|
| Sebacia Microparticles Treatment | Other | Not described Receives: Other: Sebacia Microparticles Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory Lesion Count
Percent change in number of inflammatory lesions from baseline
Measured: Months 2, 3, 6, 9 and 12
Secondary outcomes (2)
Investigator's Global Assessment
Percent of subjects clear (IGA 0) or almost clear (IGA 1)
Measured: Months 2, 3, 6, 9 and 12
Physician's Overall Assessment of Improvement
Categorical improvement from baseline (worse, no change, minimal, moderate, marked, complete)
Measured: Months 2, 3, 6, 9 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start1 Jan 2019
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sebacia, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- VP, Clinical & Regulatory Affairs, Study director, Sebacia, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03818555
- Sponsor's protocol ID
- SEB-0550
- Status last verified
- Oct 2020
- First submitted
- 24 Jan 2019
- Last updated
- 27 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Postmarket Study of Sebacia Microparticles Treatment in Patients Using Topical Acne Products for Mild to Moderate Inflammatory Acne Vulgaris
- ClinicalTrials.gov ID
- NCT03818555
- Acronym / sponsor ID
- SEB-0550
- Conditions
- Acne Vulgaris
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Sebacia, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 28 Jan 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.
Postmarket study of Sebacia Microparticles treatment during adoption into clinical use for patients with mild to moderate inflammatory acne vulgaris.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sebacia Microparticles Treatment | Other | Other: Sebacia Microparticles Treatment |
Who may qualify
- Ages
- 12 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Mild to moderate facial inflammatory acne vulgaris (IGA 2 or 3)
- Between 10 and 50 papules/pustules
- Fitzpatrick skin phototype I, II or III
- Able to provide informed consent and comply with study schedule and other requirements
Key exclusion criteria (6 listed)
- Moderately severe or severe acne vulgaris (IGA 4 or 5)
- Nodulocystic acne, significant scarring or excoriation
- Requires oral retinoid, antibiotic or corticosteroid for acne
- New or fluctuating hormone or hormone-regulating therapy
- Photosensitivity or allergy to gold
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 |
|---|---|---|
| Sebacia Microparticles TreatmentAlso: Sebacia treatment, Microparticles and Nd:Yag laser treatmentSebacia Microparticles procedure involving microparticles and 1064 nm laser. Three treatment procedures over a two-week period. | Other | Sebacia Microparticles Treatment |
Primary outcome
Inflammatory Lesion Count
Time frame: Months 2, 3, 6, 9 and 12
Percent change in number of inflammatory lesions from baseline
2 secondary outcomes
Investigator's Global Assessment
Time frame: Months 2, 3, 6, 9 and 12
Physician's Overall Assessment of Improvement
Time frame: Months 2, 3, 6, 9 and 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
- Company WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
VP, Clinical & Regulatory Affairs study director
Sebacia, Inc.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sebacia Microparticles Treatment in people with Acne Vulgaris, run by Sebacia, Inc. at 6 sites 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 6 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: status not confirmed, as of the sponsor's last update on 27 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Results are not available in the source record.
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?
Inflammatory Lesion Count (time frame: Months 2, 3, 6, 9 and 12). 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 27 Oct 2020.