Atopic DermatitisNCT02125695
Pilot Tape Harvesting Study
An observational study of Atopic Dermatitis and Healthy, run by Biogen at 2 sites in United States.
Trial 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… 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, Healthy, Discoid Lupus Erythematosus
- What is being tested?
- Skin Taping, Blood Sampling and Skin Biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 37 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2014to Aug 2016
- 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: Participants are enrolled at selected investigational sites in a standard clinical practice setting
Who may be able to join
- 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
Who cannot join
- 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.
- 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).
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Research Site
Boston, Massachusetts, 02111
Research Site
Boston, Massachusetts, 02115
About this study
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
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.
Read the 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.
- Conditions
- Atopic Dermatitis, Healthy, Discoid Lupus Erythematosus, Subacute Cutaneous Lupus Erythematosus
- Being tested
- Skin Taping, Blood Sampling, Skin Biopsy
- Medical subject headings
- Dermatitis, Atopic, Lupus Erythematosus, Discoid, Lupus Erythematosus, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin TapingProcedure or surgery
Skin taping from affected and unaffected sites (4 tape harvestings/area plus photograph of taping site)
Blood SamplingProcedure or surgery
Sampling for biomarker and basic research in CLE and AD
Skin BiopsyProcedure or surgery
As described in the treatment arm
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Skin taping; blood sampling; optional biopsy Receives: Procedure: Skin Taping; Procedure: Blood Sampling; Procedure: Skin Biopsy | |
| 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) Receives: Procedure: Skin Taping; Procedure: Blood Sampling; Procedure: Skin Biopsy | |
| Atopic dermatitis | Skin taping; blood sampling; optional skin biopsy Receives: Procedure: Skin Taping; Procedure: Blood Sampling; Procedure: Skin Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
RNA expression of genes suspected to be associated with skin disease in affected versus unaffected skin in participants with skin disease
Participants with skin disease include participants affected with cutaneous lupus erythematosus ([CLE] i.e., DLE or SCLE), SCLE, AD
Measured: Day 1
RNA expression of genes suspected to be associated with skin disease in healthy skin from HVs versus affected skin from participants with skin disease
Measured: Day 1
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
Measured: Day 1
Correlation between expression levels obtained from tape harvesting and those obtained from blood samples for each identified gene
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionAug 2016
- Study completionAug 2016
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 BiogenThe 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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02125695
- Sponsor's protocol ID
- 999LE003
- Status last verified
- Sep 2016
- First submitted
- 25 Apr 2014
- Last updated
- 28 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02125695
- Acronym / sponsor ID
- 999LE003
- Conditions
- Atopic Dermatitis, Healthy, Discoid Lupus Erythematosus, Subacute Cutaneous Lupus Erythematosus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 29 Apr 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 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | Procedure: Skin Taping, Procedure: Blood Sampling, Procedure: Skin BiopsySkin taping; blood sampling; optional biopsy |
| Cutaneous lupus erythematosus | – | Procedure: Skin Taping, Procedure: Blood Sampling, Procedure: Skin BiopsyThis group consists of participants affected with lupus (DLE, SCLE). Skin taping; blood sampling; optional skin biopsy (DLE participants); required skin biopsy (SCLE participants) |
| Atopic dermatitis | – | Procedure: Skin Taping, Procedure: Blood Sampling, Procedure: Skin BiopsySkin taping; blood sampling; optional skin biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants are enrolled at selected investigational sites in a standard clinical practice setting
Key inclusion criteria (3 listed)
- 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 (9 listed)
- 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.
- History of any clinically significant medical condition, as determined by the Investigator, that may impact study analyses
- 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).
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 |
|---|---|---|
| Skin TapingSkin taping from affected and unaffected sites (4 tape harvestings/area plus photograph of taping site) | Procedure or surgery | Atopic dermatitis, Cutaneous lupus erythematosus, Healthy Volunteers |
| Blood SamplingSampling for biomarker and basic research in CLE and AD | Procedure or surgery | Atopic dermatitis, Cutaneous lupus erythematosus, Healthy Volunteers |
| Skin BiopsyAs described in the treatment arm | Procedure or surgery | Atopic dermatitis, Cutaneous lupus erythematosus, Healthy Volunteers |
Primary outcome
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
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
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
Correlation between expression levels obtained from tape harvesting and those obtained from blood samples for each identified gene
Time frame: Day 1
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 28 Sep 2016.
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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.
Medical Director study director
Biogen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis and Healthy, run by Biogen at 2 sites in United States.
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 9 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 28 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. 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 28 Sep 2016.