PsoriasisNCT00026741
Research in Skin Inflammation
An observational study of Psoriasis, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This study will examine the production of proteins called chemokines in inflammatory skin reactions. It is thought that chemokines attract or recruit white blood cells from the blood stream into the skin when there is a skin injury or infection, causing inflammation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Psoriasis
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2001to Jan 2002
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Male or Female
Age: 33-60 years.
No ingestion of aspirin, ibuprofen, corticosteroids, COX-2 inhibitor such as Rofecoxib, or other non-steroidal anti-inflammatory agents within 7 days of start of protocol.
No history of psoriasis or other chronic skin disease.
No known underlying chronic disease for which volunteer takes systemic medications.
Immunocompromised individuals are not eligible.
Patients with an allergy to eggs and/or thimerosal are not eligible.
Individuals with a history or physical evidence of keloid or hypertrophic scarring resulting from skin trauma are not eligible.
Patients with a history of HIV, HTLV-1, or other immunodeficiency syndrome are not eligible.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
About this study
Official title: Expression of Chemokine and Chemokine Receptors in Skin in a Model of Delayed-Type Hypersensitivity
This study will examine the production of proteins called chemokines in inflammatory skin reactions. It is thought that chemokines attract or recruit white blood cells from the blood stream into the skin when there is a skin injury or infection, causing inflammation. This study will examine chemokine production in induced inflammatory reactions to try to gain a better understanding of how white blood cells are attracted to inflamed areas of the body.
Healthy normal volunteers between 33 and 60 years old may be eligible for this study if they 1) have no history of chronic skin disease; 2) are not allergic to eggs; and 3) do not tend to form large irregular scars after trauma to the skin from, for example, cuts, scratches and surgical incisions. Candidates will be asked a short series of questions and have a limited skin examination.
Read more
Participants will have 10 ml (2 tablespoons) of blood drawn from an arm vein at the start and end of the 5-day study and undergo the following procedures:
- Day 1 - Participants receive an injection in the right upper arm of mumps antigen (a protein commonly used to tests for immunization against mumps) and an injection of "vehicle" (saline plus the preservatives thimerosal, glycine and formaldehyde) in the left upper arm.
- Day 3 - Participants who develop a swelling from the mumps antigen larger than 5 mm wide will receive another injection of antigen in the right arm and another injection of vehicle in the left arm. Those whose swelling is not greater than 5 mm will be excluded from the study at this point.
- Day 5 - All four injection sites, plus another site on the left upper arm will be biopsied. For this procedure the five injection areas are numbed with a local anesthetic. A punch biopsy instrument that resembles a small cookie cutter (about one-third the diameter of a dime) is inserted about one-fifth of an inch deep into the skin and the tissue is removed. Two stitches are used to close the wound. Antibiotic and bandages are applied for 5 days. Nine days after the biopsy the participant returns to NIH for removal of the stitches.
New molecular biology techniques will be used to measure changes in chemokine production in the biopsied tissue.
Read the detailed description
In the skin, T lymphocytes are critical modulators and effectors of acquired defense responses such as delayed-type hypersensitivity (DTH). T lymphocytes and other leukocytes are recruited to the challenged site via the interaction of selectins, integrins, immunoglobulin gene superfamily molecules with their ligands, and cytokines including the large and growing chemokine group. Endogenous proinflammatory agents such as Tumor Necrosis Factor (TNF)-alpha and Interleukin-1 (IL-1) modulate lymphocyte recruitment via up-regulation of endothelial adhesion molecules and chemokines. In vitro evidence suggests that endothelial cell-derived chemokines may play a crucial role in inducing firm arrest of leukocytes on endothelial cells prior to transmigration. However, the investigation of the expression patterns and regulation of chemokines in human skin has been limited. Our goal is to qualitatively and quantitatively investigate changes in chemokine expression patterns in human skin using a DTH response to mumps antigen as a model T cell mediated immunological response. We will study the effects of intradermal injection of mumps antigen on cutaneous chemokine expression in healthy human volunteers over a five-day period. Skin biopsies of treated and mock-treated areas will be obtained and processed for state-of-the-art, real-time quantitative RT-PCR analysis of mRNA for chemokines and related molecules of interest. Routine and immunohistological analysis of chemokine receptor, chemokines, cytokines and other cell markers on fixed and frozen tissue will also be performed in an attempt to correlate chemokine expression patterns with the influx of leukocyte subsets into skin. Our hypothesis is that the chemokines will be up-regulated, but that the kinetics and expression patterns of individual chemokines may not be identical, thus possibly accounting for the differential recruitment of T lymphocytes and other leukocytes during the course of the DTH response. Chemokine expression as determined by quantitative RT-PCR will be compared with results obtained semi-quantitatively by immunohistochemical staining. This study may increase the understanding of the pathogenic mechanisms of inflammatory diseases that are characterized by the recruitment of T lymphocytes, thus possibly identifying targets for the treatment of cutaneous inflammatory diseases such as psoriasis.
- Conditions
- Psoriasis
- Keywords
- Cytokine, Inflammation, Lymphocyte, T Cell, Migration, Healthy Volunteer, Skin Biopsy
- Medical subject headings
- Psoriasis, Inflammation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2001 (estimated)
- Study startMar 2001
- Study completionJan 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Observational
- Enrolment
- 10 participants
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00026741
- Sponsor's protocol ID
- 010112
- Other IDs
- 01-C-0112
- Status last verified
- Jan 2002
- First submitted
- 14 Nov 2001
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Fitzhugh DJ, Naik S, Caughman SW, Hwang ST. Cutting edge: C-C chemokine receptor 6 is essential for arrest of a subset of memory T cells on activated dermal microvascular endothelial cells under physiologic flow conditions in vitro. J Immunol. 2000 Dec 15;165(12):6677-81. doi: 10.4049/jimmunol.165.12.6677.
PubMed 11120783Feng Y, Broder CC, Kennedy PE, Berger EA. HIV-1 entry cofactor: functional cDNA cloning of a seven-transmembrane, G protein-coupled receptor. Science. 1996 May 10;272(5263):872-7. doi: 10.1126/science.272.5263.872.
PubMed 8629022Ebnet K, Vestweber D. Molecular mechanisms that control leukocyte extravasation: the selectins and the chemokines. Histochem Cell Biol. 1999 Jul;112(1):1-23. doi: 10.1007/s004180050387.
PubMed 10461808
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression of Chemokine and Chemokine Receptors in Skin in a Model of Delayed-Type Hypersensitivity
- ClinicalTrials.gov ID
- NCT00026741
- Acronym / sponsor ID
- 010112
- Conditions
- Psoriasis
- Keywords
- Cytokine, Inflammation, Lymphocyte, T Cell, Migration, Healthy Volunteer, Skin Biopsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Mar 2001
- Study completion
- Jan 2002
- First posted
- 15 Nov 2001 (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 study will examine the production of proteins called chemokines in inflammatory skin reactions. It is thought that chemokines attract or recruit white blood cells from the blood stream into the skin when there is a skin injury or infection, causing inflammation. This study will examine chemokine production in induced inflammatory reactions to try to gain a better understanding of how white blood cells are attracted to inflamed areas of the body.
Healthy normal volunteers between 33 and 60 years old may be eligible for this study if they 1) have no history of chronic skin disease; 2) are not allergic to eggs; and 3) do not tend to form large irregular scars after trauma to the skin from, for example, cuts, scratches and surgical incisions. Candidates will be asked a short series of questions and have a limited skin examination.
Participants will have 10 ml (2 tablespoons) of blood drawn from an arm vein at the start and end of the 5-day study and undergo the following procedures:
- Day 1 - Participants receive an injection in the right upper arm of mumps antigen (a protein commonly used to tests for immunization against mumps) and an injection of "vehicle" (saline plus the preservatives thimerosal, glycine and formaldehyde) in the left upper arm.
- Day 3 - Participants who develop a swelling from the mumps antigen larger than 5 mm wide will receive another injection of antigen in the right arm and another injection of vehicle in the left arm. Those whose swelling is not greater than 5 mm will be excluded from the study at this point.
- Day 5 - All four injection sites, plus another site on the left upper arm will be biopsied. For this procedure the five injection areas are numbed with a local anesthetic. A punch biopsy instrument that resembles a small cookie cutter (about one-third the diameter of a dime) is inserted about one-fifth of an inch deep into the skin and the tissue is removed. Two stitches are used to close the wound. Antibiotic and bandages are applied for 5 days. Nine days after the biopsy the participant returns to NIH for removal of the stitches.
New molecular biology techniques will be used to measure changes in chemokine production in the biopsied tissue.
Detailed description
In the skin, T lymphocytes are critical modulators and effectors of acquired defense responses such as delayed-type hypersensitivity (DTH). T lymphocytes and other leukocytes are recruited to the challenged site via the interaction of selectins, integrins, immunoglobulin gene superfamily molecules with their ligands, and cytokines including the large and growing chemokine group. Endogenous proinflammatory agents such as Tumor Necrosis Factor (TNF)-alpha and Interleukin-1 (IL-1) modulate lymphocyte recruitment via up-regulation of endothelial adhesion molecules and chemokines. In vitro evidence suggests that endothelial cell-derived chemokines may play a crucial role in inducing firm arrest of leukocytes on endothelial cells prior to transmigration. However, the investigation of the expression patterns and regulation of chemokines in human skin has been limited. Our goal is to qualitatively and quantitatively investigate changes in chemokine expression patterns in human skin using a DTH response to mumps antigen as a model T cell mediated immunological response. We will study the effects of intradermal injection of mumps antigen on cutaneous chemokine expression in healthy human volunteers over a five-day period. Skin biopsies of treated and mock-treated areas will be obtained and processed for state-of-the-art, real-time quantitative RT-PCR analysis of mRNA for chemokines and related molecules of interest. Routine and immunohistological analysis of chemokine receptor, chemokines, cytokines and other cell markers on fixed and frozen tissue will also be performed in an attempt to correlate chemokine expression patterns with the influx of leukocyte subsets into skin. Our hypothesis is that the chemokines will be up-regulated, but that the kinetics and expression patterns of individual chemokines may not be identical, thus possibly accounting for the differential recruitment of T lymphocytes and other leukocytes during the course of the DTH response. Chemokine expression as determined by quantitative RT-PCR will be compared with results obtained semi-quantitatively by immunohistochemical staining. This study may increase the understanding of the pathogenic mechanisms of inflammatory diseases that are characterized by the recruitment of T lymphocytes, thus possibly identifying targets for the treatment of cutaneous inflammatory diseases such as psoriasis.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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
Not reported in the source record.
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 4 Mar 2008.
- Background: PubMed 11120783Fitzhugh DJ, Naik S, Caughman SW, Hwang ST. Cutting edge: C-C chemokine receptor 6 is essential for arrest of a subset of memory T cells on activated dermal microvascular endothelial cells under physiologic flow conditions in vitro. J Immunol. 2000 Dec 15;165(12):6677-81. doi: 10.4049/jimmunol.165.12.6677.
- Background: PubMed 8629022Feng Y, Broder CC, Kennedy PE, Berger EA. HIV-1 entry cofactor: functional cDNA cloning of a seven-transmembrane, G protein-coupled receptor. Science. 1996 May 10;272(5263):872-7. doi: 10.1126/science.272.5263.872.
- Background: PubMed 10461808Ebnet K, Vestweber D. Molecular mechanisms that control leukocyte extravasation: the selectins and the chemokines. Histochem Cell Biol. 1999 Jul;112(1):1-23. doi: 10.1007/s004180050387.
Related trials for Psoriasis
Active, not recruitingPhase 1
Safety and Pharmacokinetics of LPX-TI641 in Rheumatoid Arthritis and Psoriatic Arthritis
Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA)
RecruitingObservational study
Glucocorticoid-induced Osteoporosis in Patients With Chronic Inflammatory Rheumatic Diseases or Psoriasis
Osteoporosis, Inflammatory Rheumatism
RecruitingPhase 1
A Study of HL40626S Tablets in Healthy Adults
Skin Disease, Immune System Disease
RecruitingObservational study
Metabolic Profiling of Immune Responses in Immune-mediated Diseases
Primary Immunodeficiency, Psoriasis
Active, not recruitingObservational study
Efficacy and Flexibility of Tildrakizumab Treatment in Patients With Moderate-to-severe Plaque Psoriasis and High Disease Burden
Psoriasis, Moderate to Severe Psoriasis
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?
An observational study of Psoriasis, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. 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 United States. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00026741, which also lists 3 linked publications.
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 4 Mar 2008.