Acne VulgarisNCT03524040
Imaging of Pilosebaceous Units and Acne Lesions by RCM and OCT Confocal Microscopy and Optical Coherence Tomography
A study testing SEB-250 in people with Acne Vulgaris, run by Merete Haedersdal at 1 site in Denmark.
Trial summary
The purpose of the study was to investigate if reflectance confocal microscopy (RCM) and optical coherence tomography (OCT) could be used in combination to investigate the morphology of pilosebaceous units and acne lesions in healthy subjects and in acne patients.Furthermore, to investigate contrast effects… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- SEB-250
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2016to Jan 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All subjects
- Healthy men and women
- 18-45 years of age at baseline
- Legally competent, able to give verbal and written consent
- Communicate in Danish verbally as well as in writing
- Women with negative pregnancy-test
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- Subject in good general health, is willing to participate and able to give informed consent, and can comply with protocol requirements.
- Fitzpatrick skin phototype I-III
- Acne skin
- Subject with previous or prior clinical diagnosis of acne vulgaris, IGA score 1-4
- Subjects with 1 - 75 inflammatory facial lesions on the cheek, forehead, and/or chin, with no more than 2 nodulocystic lesions (see Appendix II, table 4)
- Each included patient with acne should represent at least 3 of 5 acne lesions
- Subject with in good general health, willing to participate and able to give informed consent, and able to comply with protocol requirements
Who cannot join
- Pregnant and lactating women
- Subject with a known allergy to gold, or any other ingredient in the microparticle suspension
- Individuals with skin diseases or skin lesions in the area of research interest will be excluded
- Subject with tattoo in the treatment area which may interfere with or confound evaluation of the study
- Subjects with severe acne (IGA 5) with imminent scarring potential, in the opinion of the investigator
- Subject with a history of keloids which is deemed clinically relevant in the opinion of the investigator
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- Subject with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or very severe acne requiring the continuation of systemic treatment during the study period.
- Subject with active skin disease or excessive scarring that, in the opinion of the investigator, would impact the ability to administer the gold microparticles or use of OCT/RCM in the areas
- Subject having used oral retionoid therapy such as isotretionoin within 3 months prior to baseline.
- Subject having used topical retinoids, topical corticosteroids, topical antibiotics or combination therapy within 2 weeks of baseline
- Subject having used over-the-counter topical products containing azelaic acid, benzoyl peroxide, and/or salicylic acid within 1 week of baseline
- Subject having used light treatments including Intense Pulsed Light or other lasers, microdermabrasion or chemical peels in the treatment area within 3 weeks of baseline.
- Subject who has received an investigational drug or was treated with an investigational device within 30 days prior to baseline.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Imaging of Pilosebaceous Units and Acne Lesions by Reflectance Confocal Microscopy and Optical Coherence Tomography
The purpose of the study was to investigate if reflectance confocal microscopy (RCM) and optical coherence tomography (OCT) could be used in combination to investigate the morphology of pilosebaceous units and acne lesions in healthy subjects and in acne patients.Furthermore, to investigate contrast effects, biodistribution and selective photothermolysis provided by gold microparticles and diode laser pulses, using RCM, OCT and histology.
- Conditions
- Acne Vulgaris
- Being tested
- SEB-250
- Keywords
- Selective Photothermolysis, Reflectance Confocal Microscopy, Optical Coherence Tomography, Pilosebaceous Unit, Gold Microparticles
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEB-250Device
Gold microparticles (SEB-250) are massaged into 2 or 3 2x2 cm facial areas and exposed to 2 pulses from a diode laser
| Study group | Role | What they receive |
|---|---|---|
| Acne patients | Experimental | Application of gold microparticles to 2-3 facial areas Receives: Device: SEB-250 |
| Heatlhy volunteers | Experimental | Application of gold microparticles to 2 facial areas Receives: Device: SEB-250 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acne morphology
Qualitative assessment of acne lesions, pilosebaceous units and surrounding skin in RCM and OCT images
Measured: 1 year
Gold microparticle biodistribution
Evaluation of gold microparticle biodistribution and contrast effects in RCM and OCT images
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study startDec 2016
- Primary completionDec 2017
- Study completionJan 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merete Haedersdal
- Sponsor type
- University, hospital or other
- Collaborators
- Sebacia, Inc.
- Responsible party
- Sponsor-investigator, Merete Haedersdal, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03524040
- Sponsor's protocol ID
- H-16042830
- Status last verified
- May 2018
- First submitted
- 1 May 2018
- Last updated
- 14 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging of Pilosebaceous Units and Acne Lesions by Reflectance Confocal Microscopy and Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT03524040
- Acronym / sponsor ID
- H-16042830
- Conditions
- Acne Vulgaris
- Keywords
- Selective Photothermolysis, Reflectance Confocal Microscopy, Optical Coherence Tomography, Pilosebaceous Unit, Gold Microparticles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Merete HaedersdalUniversity, hospital or other
- Collaborators
- Sebacia, Inc.
- Study start
- Dec 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 14 May 2018 (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.
The purpose of the study was to investigate if reflectance confocal microscopy (RCM) and optical coherence tomography (OCT) could be used in combination to investigate the morphology of pilosebaceous units and acne lesions in healthy subjects and in acne patients.Furthermore, to investigate contrast effects, biodistribution and selective photothermolysis provided by gold microparticles and diode laser pulses, using RCM, OCT and histology.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acne patients | Experimental | Device: SEB-250Application of gold microparticles to 2-3 facial areas |
| Heatlhy volunteers | Experimental | Device: SEB-250Application of gold microparticles to 2 facial areas |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- All subjects
- Healthy men and women
- 18-45 years of age at baseline
- Legally competent, able to give verbal and written consent
- Communicate in Danish verbally as well as in writing
Key exclusion criteria (13 listed)
- Pregnant and lactating women
- Subject with a known allergy to gold, or any other ingredient in the microparticle suspension
- Individuals with skin diseases or skin lesions in the area of research interest will be excluded
- Subject with tattoo in the treatment area which may interfere with or confound evaluation of the study
- Subjects with severe acne (IGA 5) with imminent scarring potential, in the opinion of the investigator
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 |
|---|---|---|
| SEB-250Gold microparticles (SEB-250) are massaged into 2 or 3 2x2 cm facial areas and exposed to 2 pulses from a diode laser | Device | Acne patients, Heatlhy volunteers |
Primary outcome
Acne morphology
Time frame: 1 year
Qualitative assessment of acne lesions, pilosebaceous units and surrounding skin in RCM and OCT images
Gold microparticle biodistribution
Time frame: 2 years
Evaluation of gold microparticle biodistribution and contrast effects in RCM and OCT images
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 May 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SEB-250 in people with Acne Vulgaris, run by Merete Haedersdal at 1 site in Denmark.
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 13 inclusion and 13 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 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
Acne morphology (time frame: 1 year). 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 14 May 2018.