Acne VulgarisNCT03303170
Non-Significant Risk Study of Sebacia Microparticles in the Treatment of Facial Acne Vulgaris
A study testing Sebacia Microparticles and Nd:Yag Laser in people with Acne Vulgaris, run by Sebacia, Inc. at 11 sites in United States.
Trial summary
Prospective, randomized, controlled, parallel group clinical study with blinded assessment evaluating Sebacia Microparticles (SM) with Nd:Yag laser in facial 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 and Nd:Yag Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 11 sitesUnited States
- Study dates
- 25 Sep 2017to 10 Apr 2018
- 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 acne vulgaris
- At least 15 inflammatory acne lesions
- Skin phototype I - III
- Able to understand and comply with study requirements
Who cannot join
- Severe acne vulgaris
- Nodulocystic acne
- Ongoing use of medications and/or treatments for acne
- New hormone regimen (used for less than 12 weeks)
- Significant medical or mental health condition
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Austin Institute for Clinical Research
Austin, Texas, 78660
Dermatology, Laser & Vein Institute
Charlotte, North Carolina, 28207
The Center for Skin Research
Katy, Texas, 77494
Miami Dermatology & Laser Institute
Miami, Florida, 33173
International Clinical Research
Murfreesboro, Tennessee, 37130
Wake Research Associates
Raleigh, North Carolina, 27612
MediSearch Clinical Trials
Saint Joseph, Missouri, 64506
Scripps Health
San Diego, California, 92121
Meridian Clinical Research
Savannah, Georgia, 31406
Clear Dermatology & Aesthetics Center
Scottsdale, Arizona, 85255
Premier Clinical Research
Spokane, Washington, 99202
About this study
Official title: A Prospective, Multicenter, Randomized, Controlled, Evaluator-Blinded Study of the Safety and Effectiveness of Sebacia Microparticles as an Accessory to 1064 nm Nd:Yag Laser in the Treatment of Facial Inflammatory Acne Vulgaris
Prospective, randomized, controlled, parallel group clinical study with blinded assessment evaluating Sebacia Microparticles (SM) with Nd:Yag laser in facial inflammatory acne vulgaris
- Conditions
- Acne Vulgaris
- Being tested
- Sebacia Microparticles, Nd:Yag Laser
- 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 MicroparticlesDevice
Topical microparticle suspension
Nd:Yag LaserDevice
Laser delivering 1064 nm wavelength light
| Study group | Role | What they receive |
|---|---|---|
| Sebacia Microparticles | Experimental | Not described Receives: Device: Sebacia Microparticles |
| Nd:Yag Laser | Active comparator | Not described Receives: Device: Nd:Yag Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of inflammatory acne lesions
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2017
- Study start25 Sep 2017
- Primary completion10 Apr 2018
- Study completion10 Apr 2018
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sebacia, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03303170
- Sponsor's protocol ID
- SEB-0493
- Status last verified
- Oct 2019
- First submitted
- 2 Oct 2017
- Last updated
- 14 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized, Controlled, Evaluator-Blinded Study of the Safety and Effectiveness of Sebacia Microparticles as an Accessory to 1064 nm Nd:Yag Laser in the Treatment of Facial Inflammatory Acne Vulgaris
- ClinicalTrials.gov ID
- NCT03303170
- Acronym / sponsor ID
- SEB-0493
- Conditions
- Acne Vulgaris
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Sebacia, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Sep 2017 (actual)
- Primary completion
- 10 Apr 2018 (actual)
- Study completion
- 10 Apr 2018 (actual)
- First posted
- 5 Oct 2017 (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.
Prospective, randomized, controlled, parallel group clinical study with blinded assessment evaluating Sebacia Microparticles (SM) with Nd:Yag laser in facial inflammatory acne vulgaris
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sebacia Microparticles | Experimental | Device: Sebacia Microparticles |
| Nd:Yag Laser | Active comparator | Device: Nd:Yag Laser |
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 acne vulgaris
- At least 15 inflammatory acne lesions
- Skin phototype I - III
- Able to understand and comply with study requirements
Key exclusion criteria (5 listed)
- Severe acne vulgaris
- Nodulocystic acne
- Ongoing use of medications and/or treatments for acne
- New hormone regimen (used for less than 12 weeks)
- Significant medical or mental health condition
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 MicroparticlesTopical microparticle suspension | Device | Sebacia Microparticles |
| Nd:Yag LaserLaser delivering 1064 nm wavelength light | Device | Nd:Yag Laser |
Primary outcome
Change in number of inflammatory acne lesions
Time frame: Week 12
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 14 Oct 2019.
- Sponsor WebsiteLink provided by the sponsor.
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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.
11 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 and Nd:Yag Laser in people with Acne Vulgaris, run by Sebacia, Inc. at 11 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 5 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 14 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 11 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?
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?
Change in number of inflammatory acne lesions (time frame: Week 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 14 Oct 2019.