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Exploratory Study of Natural Killer Cells in Human Skin

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ClinicalTrials.gov Identifier: NCT00824889
Recruitment Status : Completed
First Posted : January 19, 2009
Last Update Posted : August 29, 2014
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Brief 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 NK cells present in the human healthy skin.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Contact Dermatitis Psoriasis Lichen Planus Graft Versus Host Disease Melanoma Other: Biopsy and sample of blood Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Exploratory Study of Natural Killer Cells in Human Skin
Study Start Date : February 2009
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
1
Healthy volunteer
Other: Biopsy and sample of blood
Biopsy and sample of blood

2
atopic dermatitis patient
Other: Biopsy and sample of blood
Biopsy and sample of blood

3
contact dermatitis patient
Other: Biopsy and sample of blood
Biopsy and sample of blood

4
psoriasis patient
Other: Biopsy and sample of blood
Biopsy and sample of blood

5
lichen planus patient
Other: Biopsy and sample of blood
Biopsy and sample of blood

6
GVH patient
Other: Biopsy and sample of blood
Biopsy and sample of blood

7
melanoma patient
Other: Biopsy and sample of blood
Biopsy and sample of blood




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  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. [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00824889


Locations
France
Service de Dermatologie- Hopital Sainte Marguerite
Marseille, France, 13385
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Principal Investigator: Caroline Gaudy-Marqueste, MD Assistance Publique des Hopitaux de Marseille

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT00824889     History of Changes
Other Study ID Numbers: 2008-A00064-51
2008-03
First Posted: January 19, 2009    Key Record Dates
Last Update Posted: August 29, 2014
Last Verified: August 2014

Additional relevant MeSH terms:
Psoriasis
Dermatitis
Dermatitis, Atopic
Eczema
Graft vs Host Disease
Lichen Planus
Dermatitis, Contact
Skin Diseases, Papulosquamous
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Lichenoid Eruptions