Acne VulgarisNCT02219074
Multiple Arm Study of Sebacia Microparticles in the Treatment of Acne Vulgaris
A study testing Sebacia microparticle and laser treatment in people with Acne Vulgaris, run by Sebacia, Inc. at 2 sites in Poland.
Trial summary
Prospective, multicenter study with multiple arms to examine the safety and effectiveness of the Sebacia Acne Treatment System for the treatment of acne vulgaris. Read more about this study
- Who is it for?
- Ages 16 to 35 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Sebacia microparticle and laser treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 2 sitesPoland
- Study dates
- Jun 2011to Oct 2016
- 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 16 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- clinical diagnosis of moderate to severe acne vulgaris
Who cannot join
- use of oral retinoid therapy in the past 12 months
- pregnancy, lactating, or planning to become pregnant
- excessive scarring in the treatment area, or other condition that would impact the ability to evaluate acne
Trial locations and contacts
2 sites in 1 country.
Poland2 sites
Specjalistyczny Gabinet Dermatologiczny
Krakow, 31-530
Military Institute of Health Services
Warsaw, 04-141
About this study
Official title: A Feasibility Study to Evaluate the Safety and Preliminary Efficacy of the Sebacia Acne Treatment System for the Treatment of Acne Vulgaris
Prospective, multicenter study with multiple arms to examine the safety and effectiveness of the Sebacia Acne Treatment System for the treatment of acne vulgaris.
- Conditions
- Acne Vulgaris
- Being tested
- Sebacia microparticle and laser treatment, Vehicle and laser 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 microparticle and laser treatmentDevice
Vehicle and laser treatmentDevice
| Study group | Role | What they receive |
|---|---|---|
| Sebacia microparticle and laser treatment | Experimental | Not described Receives: Device: Sebacia microparticle and laser treatment |
| Vehicle and laser treatment | Sham comparator | Not described Receives: Device: Vehicle and laser treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in inflammatory lesion count
Measured: Week 12
Number of adverse events
Measured: Screening to 26 weeks
Secondary outcomes (1)
Investigator Global Assessment
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 posted18 Aug 2014 (estimated)
- Study startJun 2011
- Primary completionOct 2016
- Study completionOct 2016
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
- 350 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
- NCT02219074
- Sponsor's protocol ID
- SEB-0005
- Status last verified
- Sep 2017
- First submitted
- 14 Aug 2014
- Last updated
- 7 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study to Evaluate the Safety and Preliminary Efficacy of the Sebacia Acne Treatment System for the Treatment of Acne Vulgaris
- ClinicalTrials.gov ID
- NCT02219074
- Acronym / sponsor ID
- SEB-0005
- Conditions
- Acne Vulgaris
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Sebacia, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2011 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 18 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, multicenter study with multiple arms to examine the safety and effectiveness of the Sebacia Acne Treatment System for the treatment of 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 microparticle and laser treatment | Experimental | Device: Sebacia microparticle and laser treatment |
| Vehicle and laser treatment | Sham comparator | Device: Vehicle and laser treatment |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- clinical diagnosis of moderate to severe acne vulgaris
Key exclusion criteria (3 listed)
- use of oral retinoid therapy in the past 12 months
- pregnancy, lactating, or planning to become pregnant
- excessive scarring in the treatment area, or other condition that would impact the ability to evaluate acne
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 microparticle and laser treatment | Device | Sebacia microparticle and laser treatment |
| Vehicle and laser treatment | Device | Vehicle and laser treatment |
Primary outcome
Change in inflammatory lesion count
Time frame: Week 12
Number of adverse events
Time frame: Screening to 26 weeks
1 secondary outcome
Investigator Global Assessment
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 7 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sebacia microparticle and laser treatment in people with Acne Vulgaris, run by Sebacia, Inc. at 2 sites in Poland.
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 1 inclusion and 3 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 7 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 2 sites in Poland. 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. Some participants in this study may receive a placebo. 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 inflammatory lesion count (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 7 Sep 2017.