Facial Acne VulgarisNCT02758041
A Study to Evaluate Sebacia Microparticles in Patients With Inflammatory Acne Vulgaris
A study testing Sebacia Microparticles in people with Facial Acne Vulgaris, run by Sebacia, Inc. at 3 sites in 2 countries.
Trial summary
This study is proposed to evaluate Sebacia Microparticle treatment in patients with facial inflammatory acne vulgaris. Read more about this study
- Who is it for?
- Ages 16 to 45 years
- Conditions the study is for
- Facial Acne Vulgaris
- What is being tested?
- Sebacia Microparticles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Feb 2016to Feb 2017
- 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 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male or female, 16-45 years of age.
- Moderate to moderately-severe facial inflammatory acne vulgaris
- Fitzpatrick skin phototype I-III
Who cannot join
- Pregnant, lactating, nursing or planning to become pregnant
- Tattoo in the treatment area
- Active skin disease, excessive scarring or excess facial hair in the treatment area
- Certain current or recent acne treatments
- Recent light treatments including Intense Pulsed Light or other lasers, microdermabrasion or chemical peels in the treatment area
- Contraindicated for laser treatment, or is unable or unwilling to avoid excessive sun exposure or tanning bed use
- Known allergy to gold
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Denmark2 sites
Lasercenter North
Aalborg, 9220
Department of Dermatology, Bispebjerg Hospital, Univ of Copenhagen
Copenhagen, 2400
Switzerland1 site
SKINPULSE Dermatology Laser & Beauty Center
Geneva, 1205
About this study
This study is proposed to evaluate Sebacia Microparticle treatment in patients with facial inflammatory acne vulgaris.
- Conditions
- Facial Acne Vulgaris
- Being tested
- Sebacia Microparticles
- Keywords
- Acne
- 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
| Study group | Role | What they receive |
|---|---|---|
| Sebacia Microparticles | Experimental | Not described Receives: Device: Sebacia Microparticles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent reduction in lesion count from baseline
Measured: Baseline, Week 12, Week 24, Week 36
Secondary outcomes (1)
Improvement in Investigator Global Acne Score
Measured: Baseline, Week 12, Week 24, Week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study startFeb 2016
- Primary completionJan 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sebacia, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Merete Haedersdal, MD, PhD, Principal investigator, Department of Dermatology, Bispebjerg Hospital, Univ of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02758041
- Sponsor's protocol ID
- SEB-0294CH, SEB-0400
- Status last verified
- Sep 2017
- First submitted
- 19 Apr 2016
- Last updated
- 7 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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 Study to Evaluate Sebacia Microparticles in Patients With Inflammatory Acne Vulgaris
- ClinicalTrials.gov ID
- NCT02758041
- Acronym / sponsor ID
- SEB-0294CH, SEB-0400
- Conditions
- Facial Acne Vulgaris
- Keywords
- Acne
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Sebacia, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 2 May 2016 (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.
This study is proposed to evaluate Sebacia Microparticle treatment in patients with facial inflammatory acne vulgaris.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sebacia Microparticles | Experimental | Device: Sebacia Microparticles |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Male or female, 16-45 years of age.
- Moderate to moderately-severe facial inflammatory acne vulgaris
- Fitzpatrick skin phototype I-III
Key exclusion criteria (7 listed)
- Pregnant, lactating, nursing or planning to become pregnant
- Tattoo in the treatment area
- Active skin disease, excessive scarring or excess facial hair in the treatment area
- Certain current or recent acne treatments
- Recent light treatments including Intense Pulsed Light or other lasers, microdermabrasion or chemical peels in the treatment area
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 | Device | Sebacia Microparticles |
Primary outcome
Percent reduction in lesion count from baseline
Time frame: Baseline, Week 12, Week 24, Week 36
1 secondary outcome
Improvement in Investigator Global Acne Score
Time frame: Baseline, Week 12, Week 24, Week 36
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.
- Individual participant dataSharing planned: Undecided
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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.
Merete Haedersdal, MD, PhD principal investigator
Department of Dermatology, Bispebjerg Hospital, Univ of Copenhagen
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sebacia Microparticles in people with Facial Acne Vulgaris, run by Sebacia, Inc. at 3 sites in 2 countries.
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 3 inclusion and 7 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 3 sites in Denmark, Switzerland. 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?
Percent reduction in lesion count from baseline (time frame: Baseline, Week 12, Week 24, Week 36). 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.