Atopic DermatitisNCT02270411
Inflammatory Cells From Various Pathologies
An observational study of Atopic Dermatitis and Acne Rosacea, run by Innovaderm Research Inc. at 1 site in Canada.
Trial summary
The objective of this experiment is to develop and validate in vitro methods to isolate inflammatory cells from skin biopsies for quantitative flow cytometry analysis. Real-time polymerase chain reaction (RT-PCR) will also be performed using skin biopsy samples to validate flow cytometry results. 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, Acne Rosacea, Acne Vulgaris
- How many people
- 95 participants
- Where
- 1 siteCanada
- Study dates
- May 2014to Dec 2023
- Phase
- Observational
- 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
Study population: Invitation to volunteer
Who may be able to join
- Subject, male or female, is aged 18 years or older at the screening visit.
- Female subjects of childbearing potential must have a negative urine pregnancy test at the Screening visit.
- Subjects must be able and willing to provide written informed consent and comply with the requirements of this study protocol.
- Special inclusion criterion for volunteers with atopic dermatitis, acne rosacea, acne vulgaris, psoriasis, or HS
- Patient has a history of atopic dermatitis, acne rosacea, acne vulgaris, psoriasis, or HS for at least 6 months.
- Special inclusion criterion for volunteers with atopic dermatitis
- Subject has clinically confirmed diagnosis of active atopic dermatitis, according to Hanifin and Rajka criteria
Who cannot join
- Female subject is pregnant or lactating
- Subject is currently participating in a clinical trial with an experimental drug or device
- Subject is known to have hepatitis B or hepatitis C viral infection
- Subject is known to have immune deficiency or is immunocompromised
- Subject has a known hypersensitivity/allergy to lidocaine
- Patient has a history of keloids
Show all 12Show fewer
- Patient is taking heparin, warfarin or has a contraindication to skin biopsies.
- Patient has used systemic medication, medical devices or natural health products to treat acne rosacea, atopic dermatitis, acne vulgaris, psoriasis, or HS, or UVB phototherapy within 4 weeks of biopsy day
- Patient has used oral, intravenous, intramuscular or intra-lesional or intra-articular steroids, or immunosuppressive medication within 4 weeks of biopsy day
- Patient has used a biologic agent within 24 weeks or 5 half-lives (whichever is longer) of biopsy day
- Patient has used topical medication, natural health products or medical devices to treat acne rosacea, atopic dermatitis, acne vulgaris, psoriasis, or HS on the areas to be biopsied within 2 weeks of biopsy day
- Patients is currently using or has used isotretinoin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of a Method to Isolate Inflammatory Cells From Skin Biopsies of Patients With Various Pathologies for Quantitative Flow Cytometry Analysis
The objective of this experiment is to develop and validate in vitro methods to isolate inflammatory cells from skin biopsies for quantitative flow cytometry analysis. Real-time polymerase chain reaction (RT-PCR) will also be performed using skin biopsy samples to validate flow cytometry results. Such methods could eventually be used to better understand the pathophysiology and the mechanism of action of various medications in patients with atopic dermatitis, acne rosacea or vulgaris, HS, and systemic sclerosis.
In this study, up to 15 healthy volunteers, 50 patients with atopic dermatitis, 15 patients with acne rosacea, 15 patients with psoriasis (to be used as control), 15 patients with acne vulgaris, 10 patients with psoriasis to develop a method of analysis for systemic sclerosis, and 10 patients with HS will be recruited.
Read more
For the healthy volunteers, atopic dermatitis, psoriasis and HS groups, at least one (1) and a maximum of four (4) skin biopsies (4-5 mm) per subject will be performed. Biopsies will be performed on either the trunk or the limbs, excluding the hands and the feet.
At least one (1) and a maximum of three (3) skin biopsies (2-3 mm) per subject will be collected for the acne rosacea and acne vulgaris groups from one or more body location(s) affected by the pathology.
For patients with atopic dermatitis, an optional blood draw of up to 10 mL will be collected to measure serum IgE levels. For patients with atopic dermatitis, psoriasis, and HS, an optional blood collection of up to 50 mL will be collected to perform flow cytometry on circulating blood cells to study differences in flow cytometry results between cells extracted from biopsies and circulating cells.
Read the detailed description
Innovaderm, in collaboration with "The Immunoregulation laboratories of CRCHUM" and "McGill University division of dermatology", recently developed a novel 6-hour method to study IL-17A (Interleukin) and IL-22 from fresh biopsies of psoriatic patients. This reproducible experimental approach combines enzymatic digestion and mechanical dissociation for skin cell isolation. This is followed by a multi-color flow cytometry analysis in the absence of in vitro expansion and re-stimulation. Using this method, we examined the cellular source of IL-17A and IL-22 on a small number (20x10³) of viable CD45+ (Cluster of Differentiation Antigen 45) cells that are freshly isolated from 4 mm punch skin biopsies (n=22 patients with psoriasis). The method was used for the study on "Persistence of IL-17A+ T lymphocytes and IL-17A expression in psoriatic plaques refractory to ustekinumab therapy" presented during the 72nd annual meeting of the American Academy of Dermatology in Denver. A detailed presentation of this method will be done during the upcoming annual meeting of the Society for Investigative Dermatology in Albuquerque, New Mexico.
We would like to investigate and adapt this method for other dermatological conditions such as Atopic Dermatitis, Acne Rosacea and Acne Vulgaris.
- Conditions
- Atopic Dermatitis, Acne Rosacea, Acne Vulgaris
- Medical subject headings
- Dermatitis, Atopic, Rosacea, Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Subjects | Healthy subjects. | |
| Atopic Dermatitis | Patient has a history of atopic dermatitis for at least 6 months. Subject has clinically confirmed diagnosis of active atopic dermatitis, according to Hanifin and Rajka criteria. | |
| Acne Rosacea | Patient has a history of acne rosacea for at least 6 months. | |
| Acne Vulgaris | Patient has a history of acne vulgaris for at least 6 months. | |
| Psoriasis | Patient has a history of psoriasis for at least 6 months. | |
| Hidradenitis Suppurativa (HS) | Patient has a history of HS for at least 6 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Inflammatory Cells in Skin Biopsies
The proportion of inflammatory cells in skin biopsies will be assessed by flow cytometry.
Measured: 1 Day
Secondary outcomes (1)
Expression of Inflammation-Related Genes in Skin Biopsies
The level of expression of inflammation-related genes in skin biopsies will be assessed by quantitative real-time polymerase chain reaction (qRT-PCR).
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2023
- Study completionDec 2023
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovaderm Research Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Bissonnette, MD, Principal investigator, Innovaderm Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02270411
- Sponsor's protocol ID
- Inno-6036
- Status last verified
- Jan 2024
- First submitted
- 17 Oct 2014
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Method to Isolate Inflammatory Cells From Skin Biopsies of Patients With Various Pathologies for Quantitative Flow Cytometry Analysis
- ClinicalTrials.gov ID
- NCT02270411
- Acronym / sponsor ID
- Inno-6036
- Conditions
- Atopic Dermatitis, Acne Rosacea, Acne Vulgaris
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Innovaderm Research Inc.University, hospital or other
- Study start
- May 2014
- Primary completion
- Dec 2023 (actual)
- Study completion
- Dec 2023 (actual)
- First posted
- 21 Oct 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.
The objective of this experiment is to develop and validate in vitro methods to isolate inflammatory cells from skin biopsies for quantitative flow cytometry analysis. Real-time polymerase chain reaction (RT-PCR) will also be performed using skin biopsy samples to validate flow cytometry results. Such methods could eventually be used to better understand the pathophysiology and the mechanism of action of various medications in patients with atopic dermatitis, acne rosacea or vulgaris, HS, and systemic sclerosis.
In this study, up to 15 healthy volunteers, 50 patients with atopic dermatitis, 15 patients with acne rosacea, 15 patients with psoriasis (to be used as control), 15 patients with acne vulgaris, 10 patients with psoriasis to develop a method of analysis for systemic sclerosis, and 10 patients with HS will be recruited.
For the healthy volunteers, atopic dermatitis, psoriasis and HS groups, at least one (1) and a maximum of four (4) skin biopsies (4-5 mm) per subject will be performed. Biopsies will be performed on either the trunk or the limbs, excluding the hands and the feet.
At least one (1) and a maximum of three (3) skin biopsies (2-3 mm) per subject will be collected for the acne rosacea and acne vulgaris groups from one or more body location(s) affected by the pathology.
For patients with atopic dermatitis, an optional blood draw of up to 10 mL will be collected to measure serum IgE levels. For patients with atopic dermatitis, psoriasis, and HS, an optional blood collection of up to 50 mL will be collected to perform flow cytometry on circulating blood cells to study differences in flow cytometry results between cells extracted from biopsies and circulating cells.
Detailed description
Innovaderm, in collaboration with "The Immunoregulation laboratories of CRCHUM" and "McGill University division of dermatology", recently developed a novel 6-hour method to study IL-17A (Interleukin) and IL-22 from fresh biopsies of psoriatic patients. This reproducible experimental approach combines enzymatic digestion and mechanical dissociation for skin cell isolation. This is followed by a multi-color flow cytometry analysis in the absence of in vitro expansion and re-stimulation. Using this method, we examined the cellular source of IL-17A and IL-22 on a small number (20x10³) of viable CD45+ (Cluster of Differentiation Antigen 45) cells that are freshly isolated from 4 mm punch skin biopsies (n=22 patients with psoriasis). The method was used for the study on "Persistence of IL-17A+ T lymphocytes and IL-17A expression in psoriatic plaques refractory to ustekinumab therapy" presented during the 72nd annual meeting of the American Academy of Dermatology in Denver. A detailed presentation of this method will be done during the upcoming annual meeting of the Society for Investigative Dermatology in Albuquerque, New Mexico.
We would like to investigate and adapt this method for other dermatological conditions such as Atopic Dermatitis, Acne Rosacea and Acne Vulgaris.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Healthy Subjects | – | –Healthy subjects. |
| Atopic Dermatitis | – | –Patient has a history of atopic dermatitis for at least 6 months. Subject has clinically confirmed diagnosis of active atopic dermatitis, according to Hanifin and Rajka criteria. |
| Acne Rosacea | – | –Patient has a history of acne rosacea for at least 6 months. |
| Acne Vulgaris | – | –Patient has a history of acne vulgaris for at least 6 months. |
| Psoriasis | – | –Patient has a history of psoriasis for at least 6 months. |
| Hidradenitis Suppurativa (HS) | – | –Patient has a history of HS for at least 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Invitation to volunteer
Key inclusion criteria (7 listed)
- Subject, male or female, is aged 18 years or older at the screening visit.
- Female subjects of childbearing potential must have a negative urine pregnancy test at the Screening visit.
- Subjects must be able and willing to provide written informed consent and comply with the requirements of this study protocol.
- Special inclusion criterion for volunteers with atopic dermatitis, acne rosacea, acne vulgaris, psoriasis, or HS
- Patient has a history of atopic dermatitis, acne rosacea, acne vulgaris, psoriasis, or HS for at least 6 months.
Key exclusion criteria (12 listed)
- Female subject is pregnant or lactating
- Subject is currently participating in a clinical trial with an experimental drug or device
- Subject is known to have hepatitis B or hepatitis C viral infection
- Subject is known to have immune deficiency or is immunocompromised
- Subject has a known hypersensitivity/allergy to lidocaine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of Inflammatory Cells in Skin Biopsies
Time frame: 1 Day
The proportion of inflammatory cells in skin biopsies will be assessed by flow cytometry.
1 secondary outcome
Expression of Inflammation-Related Genes in Skin Biopsies
Time frame: 1 Day
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 19 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Robert Bissonnette, MD principal investigator
Innovaderm Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis and Acne Rosacea, run by Innovaderm Research Inc. at 1 site in Canada.
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 7 inclusion and 12 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 19 Jan 2024. 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 Canada. 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?
Proportion of Inflammatory Cells in Skin Biopsies (time frame: 1 Day). 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 19 Jan 2024.