Atopic DermatitisNCT02680405
Identification of Epidermal Signatures in Patients With Atopic Dermatitis
An observational study of Atopic Dermatitis, run by National Jewish Health at 1 site in United States.
Trial summary
Atopic dermatitis is a skin disorder with an itchy, red skin rash. This may be because certain proteins are increased in the skin of AD patients. The increased expression of these proteins play an important role in the development of AD and may increase the risk for persons with AD to get skin infections and… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Skin Biopsy, Skin tape stripping and Blood draw
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Dec 2020
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study will enroll up to 50 participants who are 18 to 65 years of age. Up to 40 of the participants will have Atopic Dermatitis. Up to 10 of the participants will not have Atopic Dermatitis. Approximately 25 of the participants will be women and 25 will be men.
Who may be able to join
- Written informed consent obtained prior to any study related procedure taking place.
- Male or Female age 18-65 years inclusive at the time of screening
- Current disease state meeting the Hanifin and Rajka criteria for AD Or Non-atopic with no history of skin disease
- Atopic dermatitis that affects ≥ 15% body surface area (BSA)
- No clinically significant abnormality on the basis of medical/medication history or physical examination
Who cannot join
- Subjects who meet any of the following criteria will not be eligible:
- Active dermatologic conditions which may confound the diagnosis of AD or would interfere with assessment of treatment, such as scabies, seborrheic dermatitis, cutaneous lymphoma, ichthyosis or psoriasis
- Known active allergic or irritant contact dermatitis
- Use of topical corticosteroids or humectants (e.g. containing urea or lactic acid) within 7 days of Visit 1 and throughout the study. Standard occlusives and emollients are permitted
- Treatment of AD with a medical device (e.g. Atopiclair®, MimyX®, Epicerum®, Cerave®, etc) within 7 days of Visit 1 and throughout the study. Standard occlusive and emollients are permitted.
- Use of tanning beds or phototherapy within 8 weeks
Show all 14Show fewer
- Receipt of any marketed or investigational biologic agent within 4 months or 5 half-lives prior to Visit, whichever is longer
- Receipt of any investigational non-biologic agent within 3 months or 5 half-lives prior to Visit, whichever is longer
- Treatment with the following medications within the last 4 weeks prior to Visit:
- systemic immunosuppressive/immunomodulating drugs ((eg, methotrexate, cyclosporine, azathioprine, mycophenolate mofetil, tacrolimus, interferon gamma, intramuscular long-acting depot corticosteroid).)
- Systemic corticosteroid use (excludes topical, inhaled, or intranasal delivery)
- Topical calcineurin inhibitor use
- Known history of allergy or reaction to tape or adhesives
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
National Jewish Health and University of Colorado Denver
Denver, Colorado, 80206
About this study
Atopic dermatitis is a skin disorder with an itchy, red skin rash. This may be because certain proteins are increased in the skin of AD patients. The increased expression of these proteins play an important role in the development of AD and may increase the risk for persons with AD to get skin infections and allergies.
There are very few non-invasive ways to diagnose and monitor the development and progression of atopic dermatitis. The goal of this study is to develop laboratory tests, done on skin samples collected by tapy stripping, that can be used for early detection and monitoring the response to treatment for a variety of skin diseases, including atopic dermatitis.
Read the detailed description
Atopic dermatitis (AD) is a highly pruritic, chronic inflammatory skin disease that affects up to 25% of children and 10% of adults. Atopic skin disease is associated with significant morbidity as well as physical, psychological, and economical quality-of-life impairment. The economical impact of AD and the requirement for family support can be extraordinary and may be greater than what is typically found for asthma and type I diabetes, respectively. In many patients, the early onset of AD is the first clinical manifestation of allergic disease and often triggers the atopic march, the subsequent development of food allergy, allergic rhinitis, and asthma. The skin of AD patients is characterized by an increased Th2 axis, cellular infiltration and significant epithelial inflammation. These factors permit increased penetration of invading allergens and pathogens that further drive AD pathogenesis and pruritus (itch). Approximately 90% of AD patients are colonized with S. aureus, while only 5 - 30% of non-atopic individuals are colonized. Novel therapeutic approaches are currently in clinical trials which provide the opportunity to target pathways integral to AD disease pathogenesis. In recent years, it has been shown that AD is more heterogeneous than initially perceived. Since novel therapeutics target different pathways, one therapeutic approach may not work for all AD patients and each therapy may provide a different level of clinical benefit. Additionally, since AD manifests primarily in the skin, blood collection and analysis may not be the most indicative measurement to determine which therapy is best for each patient. Despite improved understanding of AD, validated methods to non-invasively diagnose and monitor the development or progression of AD are sorely lacking. Additionally, a non-invasive method is needed to understand inflammation at the site of disease manifestation and potentially identify which biological pathways are most relevant for a given patient. This will allow a more personalized approach to treatment of patients with AD.
The investigator has hypothesized that skin proteins are differentially expressed in the upper layers of disease versus non-disease skin tissue and that these may be used as biomarkers for skin changes linked to the development of AD. Previously a method for comparing expression of skin proteins by extracting proteins from tape strips and evaluating differences using mass spectrometry-based proteomics was developed. This non-invasive method is suitable for use in all AD patients and has been used to show an increase in specific skin proteins in AD patients versus normal controls. Despite this success, additional studies are needed to compare gene and protein expression obtained from tape strips with genomic and proteomic profiles from full thickness skin and whole blood. This proposed study will determine the validity of using non-invasive tape stripping, as a surrogate for skin biopsy and whole blood collection, to identify the inflammatory pathway most up-regulated in a given AD patient. This information will be used in defining biomarkers that will facilitate personalized medicine approaches using emerging novel therapeutics.
- Conditions
- Atopic Dermatitis
- Being tested
- Skin Biopsy, Skin tape stripping, Blood draw
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin BiopsyProcedure or surgery
Full thickness skin biopsies will be collected from each subject used for proteomic and genomic analysis of associated biomarker levels.
Skin tape strippingProcedure or surgery
Skin tape stripping used for proteomic and genomic analysis of associated biomarker levels.
Blood drawProcedure or surgery
Whole blood and serum testing used for proteomic and genomic analysis of associated biomarker levels.
| Study group | Role | What they receive |
|---|---|---|
| Atopic Dermatitis | Subjects with Atopic Dermatitis will have blood draw, skin biopsies and tape stripping Receives: Procedure: Skin Biopsy; Procedure: Skin tape stripping; Procedure: Blood draw | |
| Non Atopic Dermatitis | Subjects with no Atopic Dermatitis will have blood draw, skin biopsies and tape stripping Receives: Procedure: Skin Biopsy; Procedure: Skin tape stripping; Procedure: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epidermal Barrier Expression Levels
- Expression level of filaggrin in the epidermis
- Expression level of TSLP in the epidermis
- Expression level of Corneodesmosin in the epidermis
- Expression level of Serpin B3 in the epidermis
Measured: 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2016 (estimated)
- Study startApr 2016
- Primary completionJul 2016
- Study completionDec 2020 (estimated)
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.
- 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
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Jewish Health
- Sponsor type
- University, hospital or other
- Collaborators
- MedImmune LLC
- Responsible party
- Principal investigator, Donald Leung, MD, PhD, National Jewish Health
- Investigators
- Donald Leung, MD, PhD, Principal investigator, National Jewish Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02680405
- Sponsor's protocol ID
- HS-2930
- Status last verified
- May 2019
- First submitted
- 29 Jan 2016
- Last updated
- 10 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: The investigator will not provide results of any tests performed for this study to the participant.
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Epidermal Signatures in Patients With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT02680405
- Acronym / sponsor ID
- HS-2930
- Conditions
- Atopic Dermatitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Jewish HealthUniversity, hospital or other
- Collaborators
- MedImmune LLC
- Study start
- Apr 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Dec 2020 (estimated)
- First posted
- 11 Feb 2016 (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.
Atopic dermatitis is a skin disorder with an itchy, red skin rash. This may be because certain proteins are increased in the skin of AD patients. The increased expression of these proteins play an important role in the development of AD and may increase the risk for persons with AD to get skin infections and allergies.
There are very few non-invasive ways to diagnose and monitor the development and progression of atopic dermatitis. The goal of this study is to develop laboratory tests, done on skin samples collected by tapy stripping, that can be used for early detection and monitoring the response to treatment for a variety of skin diseases, including atopic dermatitis.
Detailed description
Atopic dermatitis (AD) is a highly pruritic, chronic inflammatory skin disease that affects up to 25% of children and 10% of adults. Atopic skin disease is associated with significant morbidity as well as physical, psychological, and economical quality-of-life impairment. The economical impact of AD and the requirement for family support can be extraordinary and may be greater than what is typically found for asthma and type I diabetes, respectively. In many patients, the early onset of AD is the first clinical manifestation of allergic disease and often triggers the atopic march, the subsequent development of food allergy, allergic rhinitis, and asthma. The skin of AD patients is characterized by an increased Th2 axis, cellular infiltration and significant epithelial inflammation. These factors permit increased penetration of invading allergens and pathogens that further drive AD pathogenesis and pruritus (itch). Approximately 90% of AD patients are colonized with S. aureus, while only 5 - 30% of non-atopic individuals are colonized. Novel therapeutic approaches are currently in clinical trials which provide the opportunity to target pathways integral to AD disease pathogenesis. In recent years, it has been shown that AD is more heterogeneous than initially perceived. Since novel therapeutics target different pathways, one therapeutic approach may not work for all AD patients and each therapy may provide a different level of clinical benefit. Additionally, since AD manifests primarily in the skin, blood collection and analysis may not be the most indicative measurement to determine which therapy is best for each patient. Despite improved understanding of AD, validated methods to non-invasively diagnose and monitor the development or progression of AD are sorely lacking. Additionally, a non-invasive method is needed to understand inflammation at the site of disease manifestation and potentially identify which biological pathways are most relevant for a given patient. This will allow a more personalized approach to treatment of patients with AD.
The investigator has hypothesized that skin proteins are differentially expressed in the upper layers of disease versus non-disease skin tissue and that these may be used as biomarkers for skin changes linked to the development of AD. Previously a method for comparing expression of skin proteins by extracting proteins from tape strips and evaluating differences using mass spectrometry-based proteomics was developed. This non-invasive method is suitable for use in all AD patients and has been used to show an increase in specific skin proteins in AD patients versus normal controls. Despite this success, additional studies are needed to compare gene and protein expression obtained from tape strips with genomic and proteomic profiles from full thickness skin and whole blood. This proposed study will determine the validity of using non-invasive tape stripping, as a surrogate for skin biopsy and whole blood collection, to identify the inflammatory pathway most up-regulated in a given AD patient. This information will be used in defining biomarkers that will facilitate personalized medicine approaches using emerging novel therapeutics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atopic Dermatitis | – | Procedure: Skin Biopsy, Procedure: Skin tape stripping, Procedure: Blood drawSubjects with Atopic Dermatitis will have blood draw, skin biopsies and tape stripping |
| Non Atopic Dermatitis | – | Procedure: Skin Biopsy, Procedure: Skin tape stripping, Procedure: Blood drawSubjects with no Atopic Dermatitis will have blood draw, skin biopsies and tape stripping |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study will enroll up to 50 participants who are 18 to 65 years of age. Up to 40 of the participants will have Atopic Dermatitis. Up to 10 of the participants will not have Atopic Dermatitis. Approximately 25 of the participants will be women and 25 will be men.
Key inclusion criteria (5 listed)
- Written informed consent obtained prior to any study related procedure taking place.
- Male or Female age 18-65 years inclusive at the time of screening
- Current disease state meeting the Hanifin and Rajka criteria for AD Or Non-atopic with no history of skin disease
- Atopic dermatitis that affects ≥ 15% body surface area (BSA)
- No clinically significant abnormality on the basis of medical/medication history or physical examination
Key exclusion criteria (14 listed)
- Active dermatologic conditions which may confound the diagnosis of AD or would interfere with assessment of treatment, such as scabies, seborrheic dermatitis, cutaneous lymphoma, ichthyosis or psoriasis
- Known active allergic or irritant contact dermatitis
- Use of topical corticosteroids or humectants (e.g. containing urea or lactic acid) within 7 days of Visit 1 and throughout the study. Standard occlusives and emollients are permitted
- Treatment of AD with a medical device (e.g. Atopiclair®, MimyX®, Epicerum®, Cerave®, etc) within 7 days of Visit 1 and throughout the study. Standard occlusive and emollients are permitted.
- Use of tanning beds or phototherapy within 8 weeks
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 BiopsyFull thickness skin biopsies will be collected from each subject used for proteomic and genomic analysis of associated biomarker levels. | Procedure or surgery | Atopic Dermatitis, Non Atopic Dermatitis |
| Skin tape strippingSkin tape stripping used for proteomic and genomic analysis of associated biomarker levels. | Procedure or surgery | Atopic Dermatitis, Non Atopic Dermatitis |
| Blood drawWhole blood and serum testing used for proteomic and genomic analysis of associated biomarker levels. | Procedure or surgery | Atopic Dermatitis, Non Atopic Dermatitis |
Primary outcome
Epidermal Barrier Expression Levels
Time frame: 2.5 years
* Expression level of filaggrin in the epidermis * Expression level of TSLP in the epidermis * Expression level of Corneodesmosin in the epidermis * Expression level of Serpin B3 in the epidermis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2019.
- Individual participant dataSharing planned: No. The investigator will not provide results of any tests performed for this study to the participant.
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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.
Donald Leung, MD, PhD principal investigator
National Jewish Health
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 Atopic Dermatitis, run by National Jewish Health at 1 site 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 5 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 10 May 2019. 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?
Results are not available in the source record.
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?
Epidermal Barrier Expression Levels (time frame: 2.5 years). 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 10 May 2019.