Scalp PsoriasisNCT02078297
IL-17 Role in Variants of Psoriasis
An observational study of Scalp Psoriasis and Pustular Palmo-plantar Psoriasis, run by Innovaderm Research Inc. at 1 site in Canada.
Trial summary
The goal of this project is to study some mechanisms involved in the dysregulation of the immune system observed in the skin of subjects with psoriasis. This will be done by analyzing specific immune cells as well as gene and protein expression in small skin samples (biopsies) from patients with psoriasis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Scalp Psoriasis, Pustular Palmo-plantar Psoriasis, Non-pustular Palmo-plantar Psoriasis
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2014to Mar 2015
- 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.
- Subject has a history of psoriasis for at least 6 months (does not apply to healthy volunteers).
- Subject has psoriasis on the trunk and/or upper limbs and/or thighs in an area suitable for a skin biopsy (does not apply to healthy volunteers).
- Subject has palmo-plantar pustular psoriasis or palmo-plantar non-pustular psoriasis or psoriasis on the scalp or elbows or lower limbs that is suitable for two skin biopsies (does not apply to healthy volunteers).
- Female subject is willing to use effective contraceptive method for at least 30 days before Day 0 and at least until Day 10. Effective contraceptive methods are:
- Barrier methods such as condom, sponge or diaphragm combined with spermicide in foam, gel or cream;
Show all 14Show fewer
- Hormonal contraception (oral, intramuscular, implant or transdermal) which include Depo-Provera, Evra and Nuvaring;
- Intrauterine device (IUD);
- Sterilization such as tubal ligation, hysterectomy or vasectomy;
- Postmenopausal state for at least 1 year
- Same-sex partner;
- Abstinence.
- 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.
Who cannot join
- Female subject is pregnant or lactating.
- Subject has used any topical treatment for psoriasis (except non medicated emollients) in the last 14 days before Day 0 with the exception of hydrocortisone and desonide for the face, groin (including genitals) and inframammary areas as well as shampoos containing tar, salicylic acid, or zinc pyrithione.
- Subject has used Ultra-Violet (UV) B phototherapy or excessive sun exposure less than 14 days before Day 0.
- Subject has used any non biological systemic therapy for the treatment of psoriasis (including Psoralen Ultra-Violet A (PUVA) therapy), systemic steroids or systemic immunosuppressants less than 28 days before Day 0. Investigational non biologics agents must be discontinued at least 28 days or 5 half lives prior to Day 0 (whichever is longer).
- Subject is currently participating in a clinical trial with an experimental drug or device.
- Subject who has used any biological therapy for the treatment of psoriasis less than 90 days before Day 0.
Show all 10Show fewer
- Subject is taking or requires oral or injectable corticosteroids. Inhaled corticosteroids for stable medical conditions are allowed. Subjects who have used oral or injectable corticosteroids less than 28 days before Day 0 are excluded.
- Subject is known to have hepatitis B or hepatitis C viral infection.
- Subject is known to have immune deficiency or is immunocompromised or currently uses or plans to use anti retroviral therapy at any time during the study.
- Subject is taking anti-coagulant medication (v.g. heparin, LMW (low molecular weight)-heparin, warfarin, anti-platelets (NSAID and aspirin will not be considered anti-platelets)) or has a contra indication to skin biopsies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Il-17a in Difficult to Treat Variants of Psoriasis Including Palmo-plantar Psoriasis
The goal of this project is to study some mechanisms involved in the dysregulation of the immune system observed in the skin of subjects with psoriasis. This will be done by analyzing specific immune cells as well as gene and protein expression in small skin samples (biopsies) from patients with psoriasis. These results will be compared to the skin of healthy subjects without psoriasis.
Read the detailed description
A total of 80 subjects with psoriasis not currently using systemic treatment, with at least one psoriatic plaque on the trunk or proximal limbs and having also more resistant to treat psoriasis areas will be recruited. These subjects will be classified in the following 5 groups according to the localization of resistant areas: scalp psoriasis (20 subjects), pustular palmo-plantar psoriasis (10 subjects), non-pustular palmo-plantar psoriasis (10 subjects), elbow psoriasis (20 subjects) and lower leg psoriasis (20 subjects).
At Day 0 visit, severity of psoriasis will be evaluated using the body surface area (BSA) and the Psoriasis Area and Severity Index (PASI).
After appropriate washout periods, all 80 subjects will have two skin biopsies: one from a plaque located on the trunk or proximal limbs and one on a plaque located on an area more resistant to treatment (scalp, palms/soles, elbow or lower leg). Each biopsy will be split in half. One part will be used for a limited immunohistochemistry panel and additional staining will be performed on samples from the pustular palmo-plantar psoriasis and non-pustular palmo-plantar psoriasis subjects to localize IL-17A and IL-23 producing cells. The other half will be used for gene expression analysis using Reverse-Transcription-Polymerase Chain Reaction (RT-PCR) for all subjects including the following genes: IL-23 (p40 \& p19), IL-17A and Human Acidic Ribosomal Protein (HARP). In addition, the expression of other specific genes of interest will be analyzed using RT-PCR for subjects with pustular palmo-plantar psoriasis and non-pustular palmo-plantar psoriasis. Moreover, four skin biopsies will be collected from 10 healthy volunteers for RT-PCR (IL-23 (p40 \& p19), IL-17A and HARP). One biopsy will be collected from the trunk and another one from a palm or a sole. A third and a fourth biopsy will be collected on additional areas (scalp, elbow or lower limb). Gene expression in plaques from areas more resistant to treatment (scalp, palms, elbows, lower legs) will be compared to gene expression in plaques from the trunk or other areas of the upper and lower limbs.
A total of 30 subjects out of 80 will also have one or two additional skin biopsies. The 10 subjects with pustular palmo-plantar psoriasis and 10 subjects with non-pustular palmo-plantar psoriasis will have one additional biopsy of the involved skin of the palm and one of a plaque on the trunk or limbs for cell isolation and cell analysis in order to explore the mechanisms involved in the increased expression of IL-17A without concurrent increase in IL-23. Ten subjects with psoriasis vulgaris on the trunk or upper limbs but without pustular or non-pustular palmo-plantar psoriasis will also have an additional biopsy performed on lesional skin. Following inflammatory cells extraction, flow cytometry combining cell surface markers and intra-cytoplasmic staining will be used to study IL-17A and IL-23 in T cells, granulocytes/mastocytes/macrophages and Ag-presenting cells. If enough cells are harvested, three antibody panels will be analyzed in the following order using flow cytometry: a T cell panel, a granulocytes / mastocytes / macrophages panel and an antigen presenting cell (APC) panel. All panels with also be evaluated with an anti-CD45 (cluster of differentiation) antibody and a viability test (Aqua live/dead). Results from flow cytometry will be compared for biopsies from palms of subjects with pustular and non-pustular palmo-plantar psoriasis, trunk or proximal limbs of subjects with pustular and non-pustular palmo-plantar psoriasis and trunk or proximal limbs of subjects with psoriasis vulgaris.
All skin biopsies will be performed at Day 0 visit and an optional study visit (Day 10) will be performed if suture removal from skin biopsies is necessary.
In addition, circulating plasma levels of IL-17A will be measured for all subjects and healthy volunteers in order to compare IL-17A levels in the 5 groups of subjects with psoriasis and healthy subjects. Moreover, correlation between IL-17A levels and PASI will be explored.
- Conditions
- Scalp Psoriasis, Pustular Palmo-plantar Psoriasis, Non-pustular Palmo-plantar Psoriasis, Elbow Psoriasis, Lower Leg Psoriasis
- Keywords
- IL-23, IL-17A, Skin biopsies
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 |
|---|---|---|
| Scalp psoriasis | Patients have at least one psoriatic lesion on trunk or and psoriasis that is more resistant to treat such as scalp psoriasis, pustular palmo-plantar psoriasis, non-pustular palmo-plantar psoriasis, elbow psoriasis and lower leg psoriasis. | |
| pustular palmo-plantar psoriasis | Patients have at least one psoriatic lesion on trunk or and psoriasis that is more resistant to treat such as scalp psoriasis, pustular palmo-plantar psoriasis, non-pustular palmo-plantar psoriasis, elbow psoriasis and lower leg psoriasis. | |
| non-pustular palmo-plantar psoriasis | Patients have at least one psoriatic lesion on trunk or and psoriasis that is more resistant to treat such as scalp psoriasis, pustular palmo-plantar psoriasis, non-pustular palmo-plantar psoriasis, elbow psoriasis and lower leg psoriasis. | |
| elbow psoriasis | Patients have at least one psoriatic lesion on trunk or and psoriasis that is more resistant to treat such as scalp psoriasis, pustular palmo-plantar psoriasis, non-pustular palmo-plantar psoriasis, elbow psoriasis and lower leg psoriasis. | |
| leg psoriasis | Patients have at least one psoriatic lesion on trunk or and psoriasis that is more resistant to treat such as scalp psoriasis, pustular palmo-plantar psoriasis, non-pustular palmo-plantar psoriasis, elbow psoriasis and lower leg psoriasis. | |
| Healthy subjects | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Source of IL 17A
Explore the cellular source of IL 17A and mechanisms involved in the higher IL 17A/IL 23 expression ratio observed in palmo plantar skin of subjects with psoriasis
Measured: Day 0
Secondary outcomes (14)
Mechanism involved in the IL 17A/IL 23 expression ratio
Explore the cellular source of IL 17A and mechanisms involved in the higher IL 17A/IL 23 expression ratio observed in palmo plantar skin of subjects with psoriasis
Measured: Day 0
Compare IL 17A expression in plaques from scalp against plaques from trunk or lower limbs
Compare IL 17A and IL 23 expression in plaques from areas more resistant to treatment (scalp, palms, elbows, lower legs) to expression in plaques from the trunk or other areas of the upper and lower limbs
Measured: Day 0
Compare IL 23 expression in plaques from scalp against plaques from trunk or lower limbs
Compare IL 17A and IL 23 expression in plaques from areas more resistant to treatment (scalp, palms, elbows, lower legs) to expression in plaques from the trunk or other areas of the upper and lower limbs
Measured: Day 0
Compare IL 17A expression in plaques from palms against plaques from trunk or lower limbs
Compare IL 17A and IL 23 expression in plaques from areas more resistant to treatment (scalp, palms, elbows, lower legs) to expression in plaques from the trunk or other areas of the upper and lower limbs
Measured: Day 0
Compare IL 23 expression in plaques from palms against plaques from trunk or lower limbs
Compare IL 17A and IL 23 expression in plaques from areas more resistant to treatment (scalp, palms, elbows, lower legs) to expression in plaques from the trunk or other areas of the upper and lower limbs
Measured: Day 0
Compare IL 17A expression in plaques from elbows against plaques from trunk or lower limbs
Compare IL 17A and IL 23 expression in plaques from areas more resistant to treatment (scalp, palms, elbows, lower legs) to expression in plaques from the trunk or other areas of the upper and lower limbs
Measured: Day 0
Compare IL 23 expression in plaques from elbows against plaques from trunk or lower limbs
Compare IL 17A and IL 23 expression in plaques from areas more resistant to treatment (scalp, palms, elbows, lower legs) to expression in plaques from the trunk or other areas of the upper and lower limbs
Measured: Day 0
Compare IL 17A expression in plaques from lower legs against plaques from trunk or lower limbs
Compare IL 17A and IL 23 expression in plaques from areas more resistant to treatment (scalp, palms, elbows, lower legs) to expression in plaques from the trunk or other areas of the upper and lower limbs
Measured: Day 0
Compare IL 23 expression in plaques from lower legs against plaques from trunk or lower limbs
Compare IL 17A and IL 23 expression in plaques from areas more resistant to treatment (scalp, palms, elbows, lower legs) to expression in plaques from the trunk or other areas of the upper and lower limbs
Measured: Day 0
IL 17A plasma levels of patients with scalp psoriasis
Compare plasma levels of IL 17A among the 5 groups of subjects with psoriasis in areas that are more resistant to treat and healthy subjects
Measured: Day 0
IL 17A plasma levels of patients with pustular palmo-plantar psoriasis
Compare plasma levels of IL 17A among the 5 groups of subjects with psoriasis in areas that are more resistant to treat and healthy subjects
Measured: Day 0
IL 17A plasma levels of patients with elbow psoriasis
Compare plasma levels of IL 17A among the 5 groups of subjects with psoriasis in areas that are more resistant to treat and healthy subjects
Measured: Day 0
IL 17A plasma levels of patients with lower leg psoriasis
Compare plasma levels of IL 17A among the 5 groups of subjects with psoriasis in areas that are more resistant to treat and healthy subjects
Measured: Day 0
IL 17A plasma levels of patients with non-pustular palmo-plantar psoriasis
Compare plasma levels of IL 17A among the 5 groups of subjects with psoriasis in areas that are more resistant to treat and healthy subjects
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionFeb 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scalp PsoriasisStudies 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
- 90 participants (estimated)
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
- NCT02078297
- Sponsor's protocol ID
- Inno-6034
- Status last verified
- Mar 2015
- First submitted
- 28 Feb 2014
- Last updated
- 27 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Il-17a in Difficult to Treat Variants of Psoriasis Including Palmo-plantar Psoriasis
- ClinicalTrials.gov ID
- NCT02078297
- Acronym / sponsor ID
- Inno-6034
- Conditions
- Scalp Psoriasis, Pustular Palmo-plantar Psoriasis, Non-pustular Palmo-plantar Psoriasis, Elbow Psoriasis, Lower Leg Psoriasis
- Keywords
- IL-23, IL-17A, Skin biopsies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Innovaderm Research Inc.University, hospital or other
- Study start
- Feb 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 5 Mar 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 goal of this project is to study some mechanisms involved in the dysregulation of the immune system observed in the skin of subjects with psoriasis. This will be done by analyzing specific immune cells as well as gene and protein expression in small skin samples (biopsies) from patients with psoriasis. These results will be compared to the skin of healthy subjects without psoriasis.
Detailed description
A total of 80 subjects with psoriasis not currently using systemic treatment, with at least one psoriatic plaque on the trunk or proximal limbs and having also more resistant to treat psoriasis areas will be recruited. These subjects will be classified in the following 5 groups according to the localization of resistant areas: scalp psoriasis (20 subjects), pustular palmo-plantar psoriasis (10 subjects), non-pustular palmo-plantar psoriasis (10 subjects), elbow psoriasis (20 subjects) and lower leg psoriasis (20 subjects).
At Day 0 visit, severity of psoriasis will be evaluated using the body surface area (BSA) and the Psoriasis Area and Severity Index (PASI).
After appropriate washout periods, all 80 subjects will have two skin biopsies: one from a plaque located on the trunk or proximal limbs and one on a plaque located on an area more resistant to treatment (scalp, palms/soles, elbow or lower leg). Each biopsy will be split in half. One part will be used for a limited immunohistochemistry panel and additional staining will be performed on samples from the pustular palmo-plantar psoriasis and non-pustular palmo-plantar psoriasis subjects to localize IL-17A and IL-23 producing cells. The other half will be used for gene expression analysis using Reverse-Transcription-Polymerase Chain Reaction (RT-PCR) for all subjects including the following genes: IL-23 (p40 \& p19), IL-17A and Human Acidic Ribosomal Protein (HARP). In addition, the expression of other specific genes of interest will be analyzed using RT-PCR for subjects with pustular palmo-plantar psoriasis and non-pustular palmo-plantar psoriasis. Moreover, four skin biopsies will be collected from 10 healthy volunteers for RT-PCR (IL-23 (p40 \& p19), IL-17A and HARP). One biopsy will be collected from the trunk and another one from a palm or a sole. A third and a fourth biopsy will be collected on additional areas (scalp, elbow or lower limb). Gene expression in plaques from areas more resistant to treatment (scalp, palms, elbows, lower legs) will be compared to gene expression in plaques from the trunk or other areas of the upper and lower limbs.
A total of 30 subjects out of 80 will also have one or two additional skin biopsies. The 10 subjects with pustular palmo-plantar psoriasis and 10 subjects with non-pustular palmo-plantar psoriasis will have one additional biopsy of the involved skin of the palm and one of a plaque on the trunk or limbs for cell isolation and cell analysis in order to explore the mechanisms involved in the increased expression of IL-17A without concurrent increase in IL-23. Ten subjects with psoriasis vulgaris on the trunk or upper limbs but without pustular or non-pustular palmo-plantar psoriasis will also have an additional biopsy performed on lesional skin. Following inflammatory cells extraction, flow cytometry combining cell surface markers and intra-cytoplasmic staining will be used to study IL-17A and IL-23 in T cells, granulocytes/mastocytes/macrophages and Ag-presenting cells. If enough cells are harvested, three antibody panels will be analyzed in the following order using flow cytometry: a T cell panel, a granulocytes / mastocytes / macrophages panel and an antigen presenting cell (APC) panel. All panels with also be evaluated with an anti-CD45 (cluster of differentiation) antibody and a viability test (Aqua live/dead). Results from flow cytometry will be compared for biopsies from palms of subjects with pustular and non-pustular palmo-plantar psoriasis, trunk or proximal limbs of subjects with pustular and non-pustular palmo-plantar psoriasis and trunk or proximal limbs of subjects with psoriasis vulgaris.
All skin biopsies will be performed at Day 0 visit and an optional study visit (Day 10) will be performed if suture removal from skin biopsies is necessary.
In addition, circulating plasma levels of IL-17A will be measured for all subjects and healthy volunteers in order to compare IL-17A levels in the 5 groups of subjects with psoriasis and healthy subjects. Moreover, correlation between IL-17A levels and PASI will be explored.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Scalp psoriasis | – | –Patients have at least one psoriatic lesion on trunk or and psoriasis that is more resistant to treat such as scalp psoriasis, pustular palmo-plantar psoriasis, non-pustular palmo-plantar psoriasis, elbow psoriasis and lower leg psoriasis. |
| pustular palmo-plantar psoriasis | – | –Patients have at least one psoriatic lesion on trunk or and psoriasis that is more resistant to treat such as scalp psoriasis, pustular palmo-plantar psoriasis, non-pustular palmo-plantar psoriasis, elbow psoriasis and lower leg psoriasis. |
| non-pustular palmo-plantar psoriasis | – | –Patients have at least one psoriatic lesion on trunk or and psoriasis that is more resistant to treat such as scalp psoriasis, pustular palmo-plantar psoriasis, non-pustular palmo-plantar psoriasis, elbow psoriasis and lower leg psoriasis. |
| elbow psoriasis | – | –Patients have at least one psoriatic lesion on trunk or and psoriasis that is more resistant to treat such as scalp psoriasis, pustular palmo-plantar psoriasis, non-pustular palmo-plantar psoriasis, elbow psoriasis and lower leg psoriasis. |
| leg psoriasis | – | –Patients have at least one psoriatic lesion on trunk or and psoriasis that is more resistant to treat such as scalp psoriasis, pustular palmo-plantar psoriasis, non-pustular palmo-plantar psoriasis, elbow psoriasis and lower leg psoriasis. |
| Healthy subjects | – | – |
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 (14 listed)
- Subject, male or female, is aged 18 years or older at the screening visit.
- Subject has a history of psoriasis for at least 6 months (does not apply to healthy volunteers).
- Subject has psoriasis on the trunk and/or upper limbs and/or thighs in an area suitable for a skin biopsy (does not apply to healthy volunteers).
- Subject has palmo-plantar pustular psoriasis or palmo-plantar non-pustular psoriasis or psoriasis on the scalp or elbows or lower limbs that is suitable for two skin biopsies (does not apply to healthy volunteers).
- Female subject is willing to use effective contraceptive method for at least 30 days before Day 0 and at least until Day 10. Effective contraceptive methods are:
Key exclusion criteria (10 listed)
- Female subject is pregnant or lactating.
- Subject has used any topical treatment for psoriasis (except non medicated emollients) in the last 14 days before Day 0 with the exception of hydrocortisone and desonide for the face, groin (including genitals) and inframammary areas as well as shampoos containing tar, salicylic acid, or zinc pyrithione.
- Subject has used Ultra-Violet (UV) B phototherapy or excessive sun exposure less than 14 days before Day 0.
- Subject has used any non biological systemic therapy for the treatment of psoriasis (including Psoralen Ultra-Violet A (PUVA) therapy), systemic steroids or systemic immunosuppressants less than 28 days before Day 0. Investigational non biologics agents must be discontinued at least 28 days or 5 half lives prior to Day 0 (whichever is longer).
- Subject is currently participating in a clinical trial with an experimental drug or device.
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
Source of IL 17A
Time frame: Day 0
Explore the cellular source of IL 17A and mechanisms involved in the higher IL 17A/IL 23 expression ratio observed in palmo plantar skin of subjects with psoriasis
14 secondary outcomes
Mechanism involved in the IL 17A/IL 23 expression ratio
Time frame: Day 0
Compare IL 17A expression in plaques from scalp against plaques from trunk or lower limbs
Time frame: Day 0
Compare IL 23 expression in plaques from scalp against plaques from trunk or lower limbs
Time frame: Day 0
Compare IL 17A expression in plaques from palms against plaques from trunk or lower limbs
Time frame: Day 0
Compare IL 23 expression in plaques from palms against plaques from trunk or lower limbs
Time frame: Day 0
Compare IL 17A expression in plaques from elbows against plaques from trunk or lower limbs
Time frame: Day 0
Compare IL 23 expression in plaques from elbows against plaques from trunk or lower limbs
Time frame: Day 0
Compare IL 17A expression in plaques from lower legs against plaques from trunk or lower limbs
Time frame: Day 0
Compare IL 23 expression in plaques from lower legs against plaques from trunk or lower limbs
Time frame: Day 0
IL 17A plasma levels of patients with scalp psoriasis
Time frame: Day 0
IL 17A plasma levels of patients with pustular palmo-plantar psoriasis
Time frame: Day 0
IL 17A plasma levels of patients with elbow psoriasis
Time frame: Day 0
IL 17A plasma levels of patients with lower leg psoriasis
Time frame: Day 0
IL 17A plasma levels of patients with non-pustular palmo-plantar psoriasis
Time frame: Day 0
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 27 Mar 2015.
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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 Scalp Psoriasis and Pustular Palmo-plantar Psoriasis, 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 14 inclusion and 10 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 27 Mar 2015. 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?
Source of IL 17A (time frame: Day 0). 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 27 Mar 2015.