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Pilot Tape Harvesting Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02125695
Recruitment Status : Completed
First Posted : April 29, 2014
Last Update Posted : September 28, 2016
Sponsor:
Information provided by (Responsible Party):
Biogen

Brief Summary:
The main objectives of the study are: To determine if RNA recovery from tape harvesting allows for the identification of a disease gene signature (e.g., interferon [IFN] signature for lupus) or other biomarkers that may differentiate affected from normal or unaffected skin; To determine if the lupus gene signature is differentially expressed in the epidermis from active discoid lupus erythematosus (DLE) or subacute cutaneous lupus erythematosus (SCLE) lesions when compared with unaffected skin from the same participants and from the skin of healthy volunteers (HVs); To determine if the atopic dermatitis (AD) gene signature is differentially expressed in the epidermis from active AD lesions when compared with unaffected skin from the same participants and from the skin of HVs; and To correlate the levels of transcripts of targeted genes in the skin by tape harvesting with those obtained from the blood.

Condition or disease Intervention/treatment
Atopic Dermatitis Healthy Discoid Lupus Erythematosus Subacute Cutaneous Lupus Erythematosus Procedure: Skin Taping Procedure: Blood Sampling Procedure: Skin Biopsy

Detailed Description:
No study drug is administered as part of this study. All participants except healthy volunteers will be treated according to standard clinical practice.

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Study Type : Observational
Actual Enrollment : 37 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: A Pilot Study to Evaluate Using Tape Harvesting to Collect Ribonucleic Acid From the Upper Epidermis of Healthy Volunteers and Subjects With Discoid Lupus, Subjects With Subacute Cutaneous Lupus, and Subjects With Atopic Dermatitis
Study Start Date : May 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema Lupus

Group/Cohort Intervention/treatment
Healthy Volunteers
Skin taping; blood sampling; optional biopsy
Procedure: Skin Taping
Skin taping from affected and unaffected sites (4 tape harvestings/area plus photograph of taping site)

Procedure: Blood Sampling
Sampling for biomarker and basic research in CLE and AD

Procedure: Skin Biopsy
As described in the treatment arm

Cutaneous lupus erythematosus
This group consists of participants affected with lupus (DLE, SCLE). Skin taping; blood sampling; optional skin biopsy (DLE participants); required skin biopsy (SCLE participants)
Procedure: Skin Taping
Skin taping from affected and unaffected sites (4 tape harvestings/area plus photograph of taping site)

Procedure: Blood Sampling
Sampling for biomarker and basic research in CLE and AD

Procedure: Skin Biopsy
As described in the treatment arm

Atopic dermatitis
Skin taping; blood sampling; optional skin biopsy
Procedure: Skin Taping
Skin taping from affected and unaffected sites (4 tape harvestings/area plus photograph of taping site)

Procedure: Blood Sampling
Sampling for biomarker and basic research in CLE and AD

Procedure: Skin Biopsy
As described in the treatment arm




Primary Outcome Measures :
  1. RNA expression of genes suspected to be associated with skin disease in affected versus unaffected skin in participants with skin disease [ Time Frame: Day 1 ]
    Participants with skin disease include participants affected with cutaneous lupus erythematosus ([CLE] i.e., DLE or SCLE), SCLE, AD

  2. RNA expression of genes suspected to be associated with skin disease in healthy skin from HVs versus affected skin from participants with skin disease [ Time Frame: Day 1 ]
  3. Comparison of RNA expression of genes suspected to be associated with skin disease in healthy skin from HVs versus unaffected skin from participants with skin disease [ Time Frame: Day 1 ]
  4. Correlation between expression levels obtained from tape harvesting and those obtained from blood samples for each identified gene [ Time Frame: Day 1 ]

Biospecimen Retention:   Samples With DNA
Specimens collected from skin taping and blood sampling.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Participants are enrolled at selected investigational sites in a standard clinical practice setting
Criteria

Key Inclusion Criteria:

  • Healthy volunteers must be in good overall health as determined by the Investigator, based on medical history, physical examination (per standard dermatology practice), and vital signs.
  • Subjects with lupus must present with active DLE or SCLE skin disease (with or without systemic manifestations of SLE, as defined by ≥4 out of 11 classification criteria for SLE).
  • Subjects with AD must have been diagnosed by the Eichenfield revised criteria of Hanifin and Rajka, disease duration for at least 2 years before Screening and disease activity defined as Investigator's Global Assessment (IGA) score ≥3 at screening

Key Exclusion Criteria:

  • History of severe allergic or anaphylactic reactions or history of allergic reactions likely to be exacerbated by tape harvesting (e.g., allergy to adhesives).
  • Other unspecified reasons that, in the opinion of the Investigator, make the subject unsuitable for enrollment.

Key Exclusion Criteria for Healthy Volunteers

  • History of any clinically significant medical condition, as determined by the Investigator, that may impact study analyses

Key Exclusion Criteria for Subjects with Discoid or Subacute Cutaneous Lupus:

  • Evidence of skin conditions other than DLE or SCLE at the Day 1 Visit that, in the opinion of the Investigator, would interfere with the study execution or analysis.
  • History of malignancy in the last 5 years (nonmelanoma skin cancer that is considered cured by the Investigator will not be exclusionary).

Key Exclusion Criteria for Subjects With Atopic Dermatitis:

  • History of any clinically significant medical condition, other than AD, as determined by the Investigator, that may impact study analyses, including, but not limited to: History of human immunodeficiency virus; History of hepatitis C virus or hepatitis B virus infection; Symptoms of bacterial or viral infection (including skin infection) within 14 days prior to the Day 1 Visit; History of malignancy in the last 5 years (nonmelanoma skin cancer that is considered cured by the Investigator will not be exclusionary).
  • Evidence of skin conditions other than AD at the Day 1 Visit that, in the opinion of the Investigator, would interfere with the study execution or analysis.

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.


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): NCT02125695


Locations
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United States, Massachusetts
Research Site
Boston, Massachusetts, United States, 02111
Research Site
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Biogen
Investigators
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Study Director: Medical Director Biogen
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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT02125695    
Other Study ID Numbers: 999LE003
First Posted: April 29, 2014    Key Record Dates
Last Update Posted: September 28, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Lupus Erythematosus, Systemic
Lupus Erythematosus, Cutaneous
Lupus Erythematosus, Discoid
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Connective Tissue Diseases
Autoimmune Diseases