Acne VulgarisNCT03573115
Multimodal Optical Imaging for Pretreatment Evaluation for Cutaneous Microparticle Delivery
A study testing Adapalene-Benzoyl Peroxide Gel 0.1-2.5% in people with Acne Vulgaris and Microparticles, run by Merete Haedersdal at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate how pretreatment with a topical medication for acne affects application and delivery of gold microparticles to the skin in acne patients. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Acne Vulgaris, Microparticles
- What is being tested?
- Adapalene-Benzoyl Peroxide Gel 0.1-2.5%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- 4 Jan 2018to 1 Aug 2020
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Patients with a clinical diagnosis of acne vulgaris, IGA score 1-3
- 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
- Fitzpatrick skin phototype I-III
- Subjects in good general health, willing to participate and able to give informed consent, and can comply with protocol requirements
- Female subjects of childbearing potential (1) must be confirmed not pregnant by a negative urine pregnancy test prior to trial treatment
- Female subjects must use one of following contraceptive techniques to be included in the study: intrauterine device (IUD) or hormonal contraception (birth control pills, birth control patch, birth control vaginal ring, birth control shot or birth control implant) (1) Female subjects are considered of childbearing potential unless they have been hysterectomized
Who cannot join
- Subjects with a known allergy to gold microparticles or Epiduo®
- Individuals with other skin disease than acne or skin lesions in the area of research interest
- Subjects with tattoo in the treatment area which may interfere with or confound evaluation of the study
- Subjects with moderate-severe to severe acne (IGA 4-5 and those presenting with either cysts or nodules) requiring continuation of systemic treatment during the study period
- Subjects with a history of keloids which is deemed clinically relevant in the opinion of the investigator
- Subjects 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
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- Pregnant and lactating women
- Subjects who have received investigational drugs or were treated with investigational devices within 30 days prior to baseline
- Treatment with oral retinoid 3 months prior to baseline
- Treatment with systemic antibiotics 4 weeks prior to baseline
- Topical retinoids, topical antibiotics or topical products with benzoyl peroxide 4 weeks prior to baseline
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate how pretreatment with a topical medication for acne affects application and delivery of gold microparticles to the skin in acne patients. In addition, the investigators want to investigate the biodistribution of gold microparticles in pretreated skin and compare this with the biodistribution of untreated skin using the non-invasive imaging techniques optical coherence tomography and reflectance confocal microscopy
Read the detailed description
Epiduo is a prescription gel that combines adapalene and benzoyl peroxide, two active substances for the external treatment of acne. Adapalene is a substance that resembles A-vitamin acid, which dissolves and prevents clog formation in the sebaceous glands. Benzoyl peroxide works by reducing the amount of bacteria while dissolving the clogs in the sebaceous glands. Epiduo is the only antibiotic-free combination for the treatment of acne.
Reflectance Confocal Microscopy (RCM) and Optical Coherence Tomography (OCT) are non-invasive imaging technologies allowing for imaging of the upper skin layers. Gold microparticles have been shown to have a contrast effect on the images. In addition to the contrast effect on images, gold microparticles have proven to be effective in the treatment of skin disease acne. The treatment with gold microparticles uses a combination of the gold microparticles and a laser. The microparticles consist of very small particles of silica, surrounded by a shell of gold. These two components of the microparticles are selected from their way of absorbing light from a laser. The particles absorb the light from the laser and are thus heated. The surrounding skin can not absorb the light and therefore will maintain its normal temperature.
- Conditions
- Acne Vulgaris, Microparticles
- Being tested
- Adapalene-Benzoyl Peroxide Gel 0.1-2.5%
- Keywords
- Optical Coherence Tomography, Reflectance Confocal Microscopy, Gold microparticles, Adapalene, Benzoyl Peroxide
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapalene-Benzoyl Peroxide Gel 0.1-2.5%Drug
Also called Seb-250
Topical gold microparticles (SEB-250) are delivered to two facial areas at baseline, patients are then prescribed a topical Adapalene-Benzoyl Peroxide Gel 0.1-2.5% for 6 weeks followed by a new exposure to gold microparticles (SEB-250)
| Study group | Role | What they receive |
|---|---|---|
| Acne patients | Experimental | Not described Receives: Drug: Adapalene-Benzoyl Peroxide Gel 0.1-2.5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gold microparticle delivery after 6 weeks of pretreatment evaluated by RCM
Quantitative evaluation of fraction of follicles with gold microparticles at baseline and after 6 weeks of study. Change in fraction of follicles with gold will be assessed.
Measured: baseline and after 6 weeks of study
Change in gold microparticle delivery after 6 weeks of pretreatment evaluated by OCT
Quantitative evaluation of depth of gold in hair follicles at baseline and after 6 weeks of pretreatment, measured in um. Change in depth will be assessed.
Measured: baseline and after 6 weeks of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2018
- Study start4 Jan 2018
- Primary completion18 Jul 2018
- Study completion1 Aug 2020
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 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
- NCT03573115
- Sponsor's protocol ID
- EudraCT: 2017-002975-25
- Status last verified
- Mar 2022
- First submitted
- 2 May 2018
- Last updated
- 21 Mar 2022
- 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 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Optical Imaging for Pretreatment Evaluation for Cutaneous Microparticle Delivery
- ClinicalTrials.gov ID
- NCT03573115
- Acronym / sponsor ID
- EudraCT: 2017-002975-25
- Conditions
- Acne Vulgaris, Microparticles
- Keywords
- Optical Coherence Tomography, Reflectance Confocal Microscopy, Gold microparticles, Adapalene, Benzoyl Peroxide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Merete HaedersdalUniversity, hospital or other
- Collaborators
- Sebacia, Inc.
- Study start
- 4 Jan 2018 (actual)
- Primary completion
- 18 Jul 2018 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 29 Jun 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 this study is to investigate how pretreatment with a topical medication for acne affects application and delivery of gold microparticles to the skin in acne patients. In addition, the investigators want to investigate the biodistribution of gold microparticles in pretreated skin and compare this with the biodistribution of untreated skin using the non-invasive imaging techniques optical coherence tomography and reflectance confocal microscopy
Detailed description
Epiduo is a prescription gel that combines adapalene and benzoyl peroxide, two active substances for the external treatment of acne. Adapalene is a substance that resembles A-vitamin acid, which dissolves and prevents clog formation in the sebaceous glands. Benzoyl peroxide works by reducing the amount of bacteria while dissolving the clogs in the sebaceous glands. Epiduo is the only antibiotic-free combination for the treatment of acne.
Reflectance Confocal Microscopy (RCM) and Optical Coherence Tomography (OCT) are non-invasive imaging technologies allowing for imaging of the upper skin layers. Gold microparticles have been shown to have a contrast effect on the images. In addition to the contrast effect on images, gold microparticles have proven to be effective in the treatment of skin disease acne. The treatment with gold microparticles uses a combination of the gold microparticles and a laser. The microparticles consist of very small particles of silica, surrounded by a shell of gold. These two components of the microparticles are selected from their way of absorbing light from a laser. The particles absorb the light from the laser and are thus heated. The surrounding skin can not absorb the light and therefore will maintain its normal temperature.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acne patients | Experimental | Drug: Adapalene-Benzoyl Peroxide Gel 0.1-2.5% |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patients with a clinical diagnosis of acne vulgaris, IGA score 1-3
- 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
- Fitzpatrick skin phototype I-III
Key exclusion criteria (11 listed)
- Subjects with a known allergy to gold microparticles or Epiduo®
- Individuals with other skin disease than acne or skin lesions in the area of research interest
- Subjects with tattoo in the treatment area which may interfere with or confound evaluation of the study
- Subjects with moderate-severe to severe acne (IGA 4-5 and those presenting with either cysts or nodules) requiring continuation of systemic treatment during the study period
- Subjects with a history of keloids which is deemed clinically relevant 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 |
|---|---|---|
| Adapalene-Benzoyl Peroxide Gel 0.1-2.5%Also: Seb-250Topical gold microparticles (SEB-250) are delivered to two facial areas at baseline, patients are then prescribed a topical Adapalene-Benzoyl Peroxide Gel 0.1-2.5% for 6 weeks followed by a new exposure to gold microparticles (SEB-250) | Drug | Acne patients |
Primary outcome
Change in gold microparticle delivery after 6 weeks of pretreatment evaluated by RCM
Time frame: baseline and after 6 weeks of study
Quantitative evaluation of fraction of follicles with gold microparticles at baseline and after 6 weeks of study. Change in fraction of follicles with gold will be assessed.
Change in gold microparticle delivery after 6 weeks of pretreatment evaluated by OCT
Time frame: baseline and after 6 weeks of study
Quantitative evaluation of depth of gold in hair follicles at baseline and after 6 weeks of pretreatment, measured in um. Change in depth will be assessed.
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 21 Mar 2022.
- 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 Adapalene-Benzoyl Peroxide Gel 0.1-2.5% in people with Acne Vulgaris and Microparticles, 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 8 inclusion and 11 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 21 Mar 2022. 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?
Change in gold microparticle delivery after 6 weeks of pretreatment evaluated by RCM (time frame: baseline and after 6 weeks of study). 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 21 Mar 2022; AzTrials last refreshed its copy on 1 Nov 2026.