Inflammatory Acne VulgarisNCT02217228
Pivotal Study of Sebacia Microparticles in the Treatment of Acne Vulgaris
A study testing Sebacia microparticles and laser and Sebacia microparticles without laser in people with Inflammatory Acne Vulgaris, run by Sebacia, Inc. at 19 sites in United States.
Trial summary
Prospective, randomized multicenter study to examine the safety and effectiveness of Sebacia microparticles with or without laser in the treatment of moderate to moderately-severe inflammatory acne vulgaris Read more about this study
- Who is it for?
- Ages 15 to 35 years
- Conditions the study is for
- Inflammatory Acne Vulgaris
- What is being tested?
- Sebacia microparticles and laser and Sebacia microparticles without laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 394 participants
- Where
- 19 sitesUnited States
- Study dates
- Sep 2014to Dec 2015
- 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 15 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Males and females, 15 - 45 years of age
- Able to provide informed consent/assent; minors will provide assent while parent or legal guardian will provide consent
- Moderate to moderately severe (3 or 4) inflammatory acne vulgaris by Investigator's Global Assessment
- Subject has 25 to 75 inflammatory lesions on the cheeks, chin and forehead, not concentrated in one area
- Subject has Fitzpatrick skin phototype I, II or III
- Subject is in good health, willing to participate and able to comply with protocol requirements
Who cannot join
- Severe acne (Investigator's Global Assessment 5) with significant scarring potential and greater than 2 nodular lesions
- Clinically relevant history of keloids
- Facial tattoos
- Acne conglobata, acne fulminans, chloracne, drug-induced acne
- Active concomitant skin disease, excessive scarring or excess facial hair
- Heavily tanned skin; unable or unwilling to avoid tanning beds/excessive sun exposure
Show all 17Show fewer
- Acne medication and therapy restrictions - time period prior to Baseline (below)
- Oral retinoids - 6 months
- Other systemic medications - 4 weeks
- Topical retinoids, steroids, antibiotics - 2 weeks
- OTC topical treatments - 1 week
- Light treatments (including IPL or laser), microdermabrasion and/or peels - 8 weeks
- Investigational drug, biologic or device - 30 days
- Gold therapy of any type for any reason - EXCLUDED
- Pregnant, lactating, nursing or planning to become pregnant during the study period
- Known allergy to gold, ethanol, diisopropyl adipate, Polysorbate 80
- Clinically relevant condition that makes participation unsafe or that would interfere with study treatment and assessment
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Shideler Clinical Research Center
Carmel, Indiana, 46032
Dermatology & Laser Center of Charleston
Charleston, South Carolina, 29414
Dermatology, Laser & Vein Specialists of the Carolinas
Charlotte, North Carolina, 28207
Clarkston Skin Research
Clarkston, Michigan, 48346
Skin Laser & Surgery Specialists of NY & NJ
Hackensack, New Jersey, 07601
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
Maryland Laser, Skin & Vein Institute
Hunt Valley, Maryland, 21030
James Q Del Rosso, DO, LLC
Las Vegas, Nevada, 89144
Miami Dermatology & Laser Institute
Miami, Florida, 33173
The Dermatology Institute-DuPage Medical Group
Naperville, Illinois, 60563
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
Austin Institute for Clinical Research
Pflugerville, Texas, 78660
Laser & Skin Surgery Center of Northern California
Sacramento, California, 95816
Center for Dermatology & Laser Surgery
Sacramento, California, 95819
Clear Dermatology & Aesthetics Center
Scottsdale, Arizona, 85255
Gwinnett Dermatology, PC
Snellville, Georgia, 30078
Spokane Dermatology Clinic
Spokane, Washington, 92204
Spencer Dermatology
St. Petersburg, Florida, 33716
Yardley Dermatology Associates
Yardley, Pennsylvania, 19067
About this study
Official title: A Randomized, Prospective, Multicenter, Controlled Study With Blinded Assessment to Determine the Safety and Effectiveness of the Sebacia Acne Treatment System in the Treatment of Inflammatory Acne Vulgaris
Prospective, randomized multicenter study to examine the safety and effectiveness of Sebacia microparticles with or without laser in the treatment of moderate to moderately-severe inflammatory acne vulgaris
- Conditions
- Inflammatory Acne Vulgaris
- Being tested
- Sebacia microparticles and laser, Vehicle suspension and laser, Sebacia microparticles without laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sebacia microparticles and laserDevice
Vehicle suspension and laserDevice
Sebacia microparticles without laserDevice
| Study group | Role | What they receive |
|---|---|---|
| Sebacia microparticles and laser | Experimental | Gold microparticle suspension + laser treatment x 3 over the course of two weeks Receives: Device: Sebacia microparticles and laser |
| Vehicle suspension and laser | Experimental | Vehicle suspension + laser treatment x 3 over the course of two weeks Receives: Device: Vehicle suspension and laser |
| Sebacia microparticles without laser | Experimental | Gold microparticle suspension treatment x 3 over the course of two weeks Receives: Device: Sebacia microparticles without laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean percent change in inflammatory lesion count from Baseline to Week 12
Measured: Week 12
Number of of adverse events
Measured: Screening to 12 Weeks
Secondary outcomes (2)
Mean absolute change in inflammatory lesion count from Baseline to Week 12
Measured: Week 12
Success by Investigator's Global Assessment at Week 12 (defined as 2-point decrease from Baseline IGA)
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 posted15 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory 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
- 394 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
- NCT02217228
- Sponsor's protocol ID
- SEB-0121
- Other IDs
- IDE #G120273
- Status last verified
- Sep 2017
- First submitted
- 11 Aug 2014
- Last updated
- 18 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Prospective, Multicenter, Controlled Study With Blinded Assessment to Determine the Safety and Effectiveness of the Sebacia Acne Treatment System in the Treatment of Inflammatory Acne Vulgaris
- ClinicalTrials.gov ID
- NCT02217228
- Acronym / sponsor ID
- SEB-0121
- Conditions
- Inflammatory Acne Vulgaris
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 394 participants (actual)
- Lead sponsor
- Sebacia, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 15 Aug 2014 (estimated)
- 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 multicenter study to examine the safety and effectiveness of Sebacia microparticles with or without laser in the treatment of moderate to moderately-severe inflammatory acne vulgaris
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sebacia microparticles and laser | Experimental | Device: Sebacia microparticles and laserGold microparticle suspension + laser treatment x 3 over the course of two weeks |
| Vehicle suspension and laser | Experimental | Device: Vehicle suspension and laserVehicle suspension + laser treatment x 3 over the course of two weeks |
| Sebacia microparticles without laser | Experimental | Device: Sebacia microparticles without laserGold microparticle suspension treatment x 3 over the course of two weeks |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Males and females, 15 - 45 years of age
- Able to provide informed consent/assent; minors will provide assent while parent or legal guardian will provide consent
- Moderate to moderately severe (3 or 4) inflammatory acne vulgaris by Investigator's Global Assessment
- Subject has 25 to 75 inflammatory lesions on the cheeks, chin and forehead, not concentrated in one area
- Subject has Fitzpatrick skin phototype I, II or III
Key exclusion criteria (17 listed)
- Severe acne (Investigator's Global Assessment 5) with significant scarring potential and greater than 2 nodular lesions
- Clinically relevant history of keloids
- Facial tattoos
- Acne conglobata, acne fulminans, chloracne, drug-induced acne
- Active concomitant skin disease, excessive scarring or excess facial hair
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 and laser | Device | Sebacia microparticles and laser |
| Vehicle suspension and laser | Device | Vehicle suspension and laser |
| Sebacia microparticles without laser | Device | Sebacia microparticles without laser |
Primary outcome
Mean percent change in inflammatory lesion count from Baseline to Week 12
Time frame: Week 12
Number of of adverse events
Time frame: Screening to 12 Weeks
2 secondary outcomes
Mean absolute change in inflammatory lesion count from Baseline to Week 12
Time frame: Week 12
Success by Investigator's Global Assessment at Week 12 (defined as 2-point decrease from Baseline IGA)
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 18 Sep 2017.
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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.
19 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 laser and Sebacia microparticles without laser in people with Inflammatory Acne Vulgaris, run by Sebacia, Inc. at 19 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 6 inclusion and 17 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 18 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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?
Mean percent change in inflammatory lesion count from Baseline to Week 12 (time frame: Week 12). The study lists 2 primary outcomes in all. 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 18 Sep 2017.