Atopic DermatitisNCT00824889
Exploratory Study of Natural Killer Cells in Human Skin
A study testing Biopsy and sample of blood in people with Atopic Dermatitis and Contact Dermatitis, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Natural Killer (NK) cells play a unique role during innate immune responses as they are able to recognize and eliminate, without specific sensitization, tumors, microbe-infected cells as well as allogeneic cells.In a first time, we will characterize the tissue distribution, the phenotype and the effector functions of… 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, Contact Dermatitis, Psoriasis
- What is being tested?
- Biopsy and sample of blood
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2009to Nov 2011
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Consent obtained after healthy donor or patient information.
- Patients suffering from one of the following diseases: a) atopic dermatitis ; b) contact dermatitis; c) psoriasis ; d) lichen planus ; e) GVH ; f) melanoma.
Who cannot join
- Age below 18,
- pregnant or breastfeeding women,
- persons under guardianship, persons without social security, prisoners, persons hospitalized without consent on the basis of French laws L. 3212-1 et L. 3213-1. Patients affected by HIV infection, AIDS, Hepatitis A, B or C infection.
- Neutropenia <1000/mm3.
- Thrombopenia <50 000/mm3.
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Dermatologie- Hopital Sainte Marguerite
Marseille, 13385
About this study
Natural Killer (NK) cells play a unique role during innate immune responses as they are able to recognize and eliminate, without specific sensitization, tumors, microbe-infected cells as well as allogeneic cells.In a first time, we will characterize the tissue distribution, the phenotype and the effector functions of NK cells present in the human healthy skin.
Read the detailed description
Then, we will define whether these parameters are qualitatively/ quantitatively modified in the following skin pathologies: a) atopic dermatitis; b) contact dermatitis; c) psoriasis ; d) lichen planus ; e) GVH (graft versus host disease) ; (f) melanoma.
- Conditions
- Atopic Dermatitis, Contact Dermatitis, Psoriasis, Lichen Planus, Graft Versus Host Disease, Melanoma
- Being tested
- Biopsy and sample of blood
- Medical subject headings
- Dermatitis, Atopic, Dermatitis, Contact, Psoriasis, Lichen Planus, Graft vs Host Disease, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsy and sample of bloodOther
Biopsy and sample of blood
Biopsy and sample of bloodOther
Biopsy and sample of blood
Biopsy and sample of bloodOther
Biopsy and sample of blood
Biopsy and sample of bloodOther
Biopsy and sample of blood
Biopsy and sample of bloodOther
Biopsy and sample of blood
Biopsy and sample of bloodOther
Biopsy and sample of blood
Biopsy and sample of bloodOther
Biopsy and sample of blood
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Healthy volunteer Receives: Other: Biopsy and sample of blood |
| 2 | Other | atopic dermatitis patient Receives: Other: Biopsy and sample of blood |
| 3 | Other | contact dermatitis patient Receives: Other: Biopsy and sample of blood |
| 4 | Other | psoriasis patient Receives: Other: Biopsy and sample of blood |
| 5 | Other | lichen planus patient Receives: Other: Biopsy and sample of blood |
| 6 | Other | GVH patient Receives: Other: Biopsy and sample of blood |
| 7 | Other | melanoma patient Receives: Other: Biopsy and sample of blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
In a first time, we will characterize the tissue distribution, the phenotype and the effector functions of NK cells present in the human healthy skin.
Measured: 12 months
Secondary outcomes (1)
To determine whether the eventual modifications detected in skin pathologies are correlated to qualitative/ quantitative alterations of NK cell subsets present in the peripheral blood.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2009 (estimated)
- Study startFeb 2009
- Primary completionNov 2011
- Study completionNov 2011
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 Assistance Publique Hopitaux De MarseilleThe 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
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline Gaudy-Marqueste, MD, Principal investigator, Assistance Publique des Hopitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00824889
- Sponsor's protocol ID
- 2008-A00064-51
- Other IDs
- 2008-03
- Status last verified
- Aug 2014
- First submitted
- 13 Jan 2009
- Last updated
- 29 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of Natural Killer Cells in Human Skin
- ClinicalTrials.gov ID
- NCT00824889
- Acronym / sponsor ID
- 2008-A00064-51
- Conditions
- Atopic Dermatitis, Contact Dermatitis, Psoriasis, Lichen Planus, Graft Versus Host Disease, Melanoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 19 Jan 2009 (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.
Natural Killer (NK) cells play a unique role during innate immune responses as they are able to recognize and eliminate, without specific sensitization, tumors, microbe-infected cells as well as allogeneic cells.In a first time, we will characterize the tissue distribution, the phenotype and the effector functions of NK cells present in the human healthy skin.
Detailed description
Then, we will define whether these parameters are qualitatively/ quantitatively modified in the following skin pathologies: a) atopic dermatitis; b) contact dermatitis; c) psoriasis ; d) lichen planus ; e) GVH (graft versus host disease) ; (f) melanoma.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: Biopsy and sample of bloodHealthy volunteer |
| 2 | Other | Other: Biopsy and sample of bloodatopic dermatitis patient |
| 3 | Other | Other: Biopsy and sample of bloodcontact dermatitis patient |
| 4 | Other | Other: Biopsy and sample of bloodpsoriasis patient |
| 5 | Other | Other: Biopsy and sample of bloodlichen planus patient |
| 6 | Other | Other: Biopsy and sample of bloodGVH patient |
| 7 | Other | Other: Biopsy and sample of bloodmelanoma patient |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years.
- Consent obtained after healthy donor or patient information.
- Patients suffering from one of the following diseases: a) atopic dermatitis ; b) contact dermatitis; c) psoriasis ; d) lichen planus ; e) GVH ; f) melanoma.
Key exclusion criteria (5 listed)
- Age below 18,
- pregnant or breastfeeding women,
- persons under guardianship, persons without social security, prisoners, persons hospitalized without consent on the basis of French laws L. 3212-1 et L. 3213-1. Patients affected by HIV infection, AIDS, Hepatitis A, B or C infection.
- Neutropenia <1000/mm3.
- Thrombopenia <50 000/mm3.
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 |
|---|---|---|
| Biopsy and sample of bloodBiopsy and sample of blood | Other | 1 |
| Biopsy and sample of bloodBiopsy and sample of blood | Other | 2 |
| Biopsy and sample of bloodBiopsy and sample of blood | Other | 3 |
| Biopsy and sample of bloodBiopsy and sample of blood | Other | 4 |
| Biopsy and sample of bloodBiopsy and sample of blood | Other | 5 |
| Biopsy and sample of bloodBiopsy and sample of blood | Other | 6 |
| Biopsy and sample of bloodBiopsy and sample of blood | Other | 7 |
Primary outcome
In a first time, we will characterize the tissue distribution, the phenotype and the effector functions of NK cells present in the human healthy skin.
Time frame: 12 months
1 secondary outcome
To determine whether the eventual modifications detected in skin pathologies are correlated to qualitative/ quantitative alterations of NK cell subsets present in the peripheral blood.
Time frame: 12 months
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 29 Aug 2014.
Related trials for Atopic Dermatitis
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
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.
Caroline Gaudy-Marqueste, MD principal investigator
Assistance Publique des Hopitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsy and sample of blood in people with Atopic Dermatitis and Contact Dermatitis, run by Assistance Publique Hopitaux De Marseille 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 3 inclusion and 5 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 29 Aug 2014. 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.
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?
In a first time, we will characterize the tissue distribution, the phenotype and the effector functions of NK cells present in the human healthy skin. (time frame: 12 months). 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 29 Aug 2014.