Atopic DermatitisNCT00696397
Comprehensive Investigation of Opiates, Neuropeptides, Barrier Function, Scratching and Sleep Physiology
An observational study of Atopic Dermatitis, run by Wake Forest University at 1 site in United States.
Trial summary
The purpose of this research is to study the sleep patterns of people with moderate to severe atopic dermatitis and how itching affects those patterns. This study will also measure your body's activity during sleep using non-invasive tests described below. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Dec 2009
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: adult men and women between 18 and 50 years of age with atopic dermatitis
Who may be able to join
- Adult men and women who are between 18 and 50 years of age
- Diagnosis of moderate to severe atopic dermatitis including involvement of the forearm confirmed by published consensus diagnostic criteria57 (except for healthy control subjects)
- Subjects must be in general good health with no other skin disease, disease state or physical condition which would impair evaluation of their skin or which would increase their health risk by study participation
- Subjects must be willing to stay overnight in the sleep laboratory and/or to undergo dermal microdialysis
- Women of child bearing age will be required to have a negative pregnancy test in order to enroll in the study and will be required to maintain adequate birth control throughout the study.
Who cannot join
- Adults over age 50
- Children less than 18 years of age.
- Unable to complete the required measures
- Diagnosis with other skin diseases that would affect the measurement of transepidermal water loss (TEWL) as determined by the investigators
- Currently enrolled in any investigational study in which the subject is receiving any type of drug, biologic, or non-drug therapy and patients undergoing treatment with another investigational drug or approved therapy for investigational use within 28 days prior to study participation
- Evidence of depression based on the Beck Depression Inventory (BDI > 10)
Show all 24Show fewer
- Evidence of sleep apnea based on the results of the Epworth Sleepiness Scale score (ESS > 10)
- Evidence of insomnia based on the Insomnia Severity Index (ISI) that is determined by the principal investigator to be unrelated to atopic dermatitis
- Individuals who work shifts between 8 pm and 6 am because such night shifts can alter subjects' circadian rhythms.
- Typically sleep less than 5 hours per night
- Reported habitual bedtime earlier than 9pm or later than 1 am (> 2 times per week on screening diaries)
- Reported habitual rising time later than 9 am (> 2 times per week on screening diaries
- Diagnosis of sleep apnea, periodic limb movement disorder, or restless leg syndrome 58
- Consumption of more than 3 alcoholic beverages per day
- Consumption of more than 4 caffeinated beverages per day 59-61
- Chronic pain judged to be a significant sleep-disturbing factor as determined by the investigators62
- Current treatment with lipophilic beta blockers, opioids, glucocorticoids, theophylline, or other medications known to interfere with sleep as determined by the investigators 63-69
- Uncontrolled asthma or COPD 70-73
- Uncontrolled thyroid disease 74,75
- Poorly controlled diabetes mellitus
- Poorly compensated congestive heart failure 76
- Use of herbal or naturopathic treatments for sleep
- Habitual smoking between 11 pm and 7 am 77,78
- Use of illicit drugs
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences Dermatology
Winston-Salem, North Carolina, 27157
About this study
Official title: Sleep Disturbance in Atopic Dermatitis: A Comprehensive Investigation of Opiates, Neuropeptides, Barrier Function, Scratching and Sleep Physiology
The purpose of this research is to study the sleep patterns of people with moderate to severe atopic dermatitis and how itching affects those patterns. This study will also measure your body's activity during sleep using non-invasive tests described below.
- Conditions
- Atopic Dermatitis
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A | adult men and women between 18 and 50 years of age with atopic dermatitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess whether there are differences in dermal and serum opiate levels and neuropeptides involved in atopic dermatitis between day and night
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2008 (estimated)
- Study startMar 2006
- Primary completionDec 2009
- Study completionDec 2009
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gil Yosipovitch, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00696397
- Sponsor's protocol ID
- 00000046
- Status last verified
- Aug 2012
- First submitted
- 9 Jun 2008
- Last updated
- 16 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Disturbance in Atopic Dermatitis: A Comprehensive Investigation of Opiates, Neuropeptides, Barrier Function, Scratching and Sleep Physiology
- ClinicalTrials.gov ID
- NCT00696397
- Acronym / sponsor ID
- 00000046
- Conditions
- Atopic Dermatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 12 Jun 2008 (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 purpose of this research is to study the sleep patterns of people with moderate to severe atopic dermatitis and how itching affects those patterns. This study will also measure your body's activity during sleep using non-invasive tests described below.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | –adult men and women between 18 and 50 years of age with atopic dermatitis |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- adult men and women between 18 and 50 years of age with atopic dermatitis
Key inclusion criteria (5 listed)
- Adult men and women who are between 18 and 50 years of age
- Diagnosis of moderate to severe atopic dermatitis including involvement of the forearm confirmed by published consensus diagnostic criteria57 (except for healthy control subjects)
- Subjects must be in general good health with no other skin disease, disease state or physical condition which would impair evaluation of their skin or which would increase their health risk by study participation
- Subjects must be willing to stay overnight in the sleep laboratory and/or to undergo dermal microdialysis
- Women of child bearing age will be required to have a negative pregnancy test in order to enroll in the study and will be required to maintain adequate birth control throughout the study.
Key exclusion criteria (24 listed)
- Adults over age 50
- Children less than 18 years of age.
- Unable to complete the required measures
- Diagnosis with other skin diseases that would affect the measurement of transepidermal water loss (TEWL) as determined by the investigators
- Currently enrolled in any investigational study in which the subject is receiving any type of drug, biologic, or non-drug therapy and patients undergoing treatment with another investigational drug or approved therapy for investigational use within 28 days prior to study participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To assess whether there are differences in dermal and serum opiate levels and neuropeptides involved in atopic dermatitis between day and night
Time frame: 1 day
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 16 Mar 2017.
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.
Gil Yosipovitch, MD principal investigator
Wake Forest University Health Sciences
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 Wake Forest University 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 24 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 16 Mar 2017. 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?
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?
To assess whether there are differences in dermal and serum opiate levels and neuropeptides involved in atopic dermatitis between day and night (time frame: 1 day). 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 16 Mar 2017.