Atopic DermatitisEarly Phase 1MicroIskinNCT02369432
Exploratory Study of the Cutaneous Penetration of Biodegradable Polymeric Microparticles in Atopic Dermatitis
A Early Phase 1 study testing Biodegradable and biocompatible polymeric microparticles containing a fluorochrome applied to the skin followed by a skin biopsy in people with Atopic Dermatitis, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
This proof of concept study aims to assess in patients suffering from atopic dermatitis if polymeric microparticles reach the pilosebaceous follicles of inflamed skin. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Biodegradable and biocompatible polymeric microparticles containing a fluorochrome applied to the skin followed by a skin biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- 20 Feb 2015to 3 Oct 2017
- Phase
- Early Phase 1
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers:
- Volunteers over 18
- Male volunteers under 65 or women of childbearing age (with a negative pregnancy test obtained at least 3 weeks before inclusion)
- Caucasian volunteers
- Volunteers having never shown any type of skin lesions regardless of its origin especially any allergic skin reactions.
- Volunteers having signed a free and informed consent form
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- Volunteers affiliated to a social security system
- Patients:
- Patients over 18
- Male patients under 65 or women of childbearing age (with a negative pregnancy test obtained at least 3 weeks before inclusion)
- Caucasian patients
- Acute phase of atopic dermatitis with a SCORAD between 15 and 40
- Patients suffering from atopic dermatitis skin lesions ≥ 1.5 cm² on the inside of the forearm
- Patients having been treated by class II dermocorticoids with a two-week wash-out prior to inclusion
- Patients having signed a free and informed consent form
- Patients affiliated to a social security system
Who cannot join
- Participants under 18
- Pregnant or Breastfeeding women
- Post-menopausal women
- Patients having skin lesions adjacent to the selected area
- Patients with complications of atopic dermatitis
- SCORAD <15 or >40
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- Patients being treated with a topical or a systemic treatment influencing the skin penetration of the microparticles
- Patients allergics to any component of the formulation
- Patients using cosmetic products on their forearms
- Patients planning to expose themselves to the sun
- Patients with a known immune deficiency
- Patients allergic to any product or device used before, during or after the skin biopsy
- Patients suffering from known wound healing disorders
- Patients with known inherited ou acquired hemostasis disorders
- Patients unable to follow the protocol requirements
- Patients currently involved in another clinical trial (or whose participation has ended less than 2 weeks before inclusion)
- Patients who are not affiliated to a social security system
- Patients in an exclusion period following participation in another clinical trial
- Incapacitated adults
- Participants placed under tutorship or curatorship
- Participants under judicial protection
Trial locations and contacts
1 site in 1 country.
About this study
This proof of concept study aims to assess in patients suffering from atopic dermatitis if polymeric microparticles reach the pilosebaceous follicles of inflamed skin.
Read the detailed description
Current treatments of inflammatory skin disorders such as acne, psoriasis or atopic dermatitis are primarily topical. They have the advantage of allowing the administration of active substances directly to the skin lesions.
However local treatments may have drawbacks (complex application, local and/or systemic side effects...) and cause poor compliance.
The use of drug carriers is viewed as one of the most promising strategies to target and control the release of active substances to various skin sites. Polymeric microparticles have shown to have a better stability and a more sustained release pattern than other types of drug vehicles such as liposomes.
Based on the results obtained in our preclinical experiments, this proof of concept study aims to assess, in patients suffering from atopic dermatitis, if biodegradable polymeric microparticles reach the pilosebaceous follicles of inflamed skin which would in turn serve as a reservoir of active substance.
- Conditions
- Atopic Dermatitis
- Being tested
- Biodegradable and biocompatible polymeric microparticles containing a fluorochrome applied to the skin followed by a skin biopsy
- Keywords
- Drug carriers, Polymeric microparticles, Preferential accumulation in inflamed skin, Atopic dermatitis, Pilosebaceous follicles, Selective drug delivery, Drug reservoir
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biodegradable and biocompatible polymeric microparticles containing a fluorochrome applied to the skin followed by a skin biopsyDrug
| Study group | Role | What they receive |
|---|---|---|
| Group of healthy volunteers and group of patients | Experimental | * Healthy volunteers: Microparticles will be applied to the skin of the forearm and then a skin biopsy of this area will be performed
* Patients suffering from atopic dermatitis: Microparticles will be applied to the skin of the forearm both to an area affected by dermatitis and to an area deprived from the disease. A skin biopsy of these two areas will be performed Receives: Drug: Biodegradable and biocompatible polymeric microparticles containing a fluorochrome applied to the skin followed by a skin biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the penetration beyond the stratum corneum in human skin (fluorochrome contained in the particle will be detected by confocal microscopy)
- Healthy volunteers: Microparticles are applied to the skin of the forearm and then a skin biopsy of this area is performed
- Patients suffering from atopic dermatitis: Microparticles are applied to the skin of the forearm both to an area affected by dermatitis and to an area deprived from the disease. A skin biopsy of these two areas is performed.
The fluorochrome contained in the particle will be detected by confocal microscopy to determine whether the particles have reached beyond the stratum corneum
Measured: Day 3
Secondary outcomes (1)
Assessment of the quantity of fluorescence (assessed by number of pixels on pictures taken with confocal microscopy)
This will be assessed by the number of pixels on pictures taken with confocal microscopy. It will allow for the comparison between patients/healthy volunteers and the comparison of affected/non-affected area in patients
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2015 (estimated)
- Study start20 Feb 2015
- Primary completion3 Oct 2017
- Study completion3 Oct 2017
Why it stopped: Difficulties in enrolling patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Collaborators
- University of Franche-Comté
- Responsible party
- Sponsor
- Investigators
- Philippe HUMBERT, Principal investigator, Centre Hospitalier Universitaire de Besancon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02369432
- Sponsor's protocol ID
- API/2012/32
- Acronym
- MicroIskin
- Status last verified
- Oct 2017
- First submitted
- 16 Feb 2015
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of the Cutaneous Penetration of Biodegradable Polymeric Microparticles in Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT02369432
- Acronym / sponsor ID
- MicroIskin / API/2012/32
- Conditions
- Atopic Dermatitis
- Keywords
- Drug carriers, Polymeric microparticles, Preferential accumulation in inflamed skin, Atopic dermatitis, Pilosebaceous follicles, Selective drug delivery, Drug reservoir
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties in enrolling patients
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Collaborators
- University of Franche-Comté
- Study start
- 20 Feb 2015 (actual)
- Primary completion
- 3 Oct 2017 (actual)
- Study completion
- 3 Oct 2017 (actual)
- First posted
- 24 Feb 2015 (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 proof of concept study aims to assess in patients suffering from atopic dermatitis if polymeric microparticles reach the pilosebaceous follicles of inflamed skin.
Detailed description
Current treatments of inflammatory skin disorders such as acne, psoriasis or atopic dermatitis are primarily topical. They have the advantage of allowing the administration of active substances directly to the skin lesions.
However local treatments may have drawbacks (complex application, local and/or systemic side effects...) and cause poor compliance.
The use of drug carriers is viewed as one of the most promising strategies to target and control the release of active substances to various skin sites. Polymeric microparticles have shown to have a better stability and a more sustained release pattern than other types of drug vehicles such as liposomes.
Based on the results obtained in our preclinical experiments, this proof of concept study aims to assess, in patients suffering from atopic dermatitis, if biodegradable polymeric microparticles reach the pilosebaceous follicles of inflamed skin which would in turn serve as a reservoir of active substance.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group of healthy volunteers and group of patients | Experimental | Drug: Biodegradable and biocompatible polymeric microparticles containing a fluorochrome applied to the skin followed by a skin biopsy* Healthy volunteers: Microparticles will be applied to the skin of the forearm and then a skin biopsy of this area will be performed * Patients suffering from atopic dermatitis: Microparticles will be applied to the skin of the forearm both to an area affected by dermatitis and to an area deprived from the disease. A skin biopsy of these two areas will be performed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Healthy volunteers:
- Patients:
Key exclusion criteria (21 listed)
- Participants under 18
- Pregnant or Breastfeeding women
- Post-menopausal women
- Patients having skin lesions adjacent to the selected area
- Patients with complications of atopic dermatitis
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 |
|---|---|---|
| Biodegradable and biocompatible polymeric microparticles containing a fluorochrome applied to the skin followed by a skin biopsy | Drug | Group of healthy volunteers and group of patients |
Primary outcome
Assessment of the penetration beyond the stratum corneum in human skin (fluorochrome contained in the particle will be detected by confocal microscopy)
Time frame: Day 3
* Healthy volunteers: Microparticles are applied to the skin of the forearm and then a skin biopsy of this area is performed * Patients suffering from atopic dermatitis: Microparticles are applied to the skin of the forearm both to an area affected by dermatitis and to an area deprived from the disease. A skin biopsy of these two areas is performed. The fluorochrome contained in the particle will be detected by confocal microscopy to determine whether the particles have reached beyond the stratum corneum
1 secondary outcome
Assessment of the quantity of fluorescence (assessed by number of pixels on pictures taken with confocal microscopy)
Time frame: Day 3
Results and safety
The study was stopped early (reason given: Difficulties in enrolling patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 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.
Philippe HUMBERT principal investigator
Centre Hospitalier Universitaire de Besancon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Biodegradable and biocompatible polymeric microparticles containing a fluorochrome applied to the skin followed by a skin biopsy in people with Atopic Dermatitis, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
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 16 inclusion and 21 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: stopped early, as of the sponsor's last update on 13 Oct 2017. 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 France. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Difficulties in enrolling patients). Results are not available in the source record.
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?
Assessment of the penetration beyond the stratum corneum in human skin (fluorochrome contained in the particle will be detected by confocal microscopy) (time frame: Day 3). 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 13 Oct 2017.