Atopic DermatitisNCT00660127
The Effect of Visual Stimuli on Itch Perception Intensity in Healthy and Atopic Dermatitis Patients
An observational study of Atopic Dermatitis, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of this research study is to assess whether seeing other people itch affects itch perception in patients with atopic dermatitis and healthy subjects. 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
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: general community population
Who may be able to join
- Adult men and women who are between 18 and 65 years of age
- Diagnosis of moderate to severe atopic dermatitis including involvement of the forearm confirmed by published consensus diagnostic criteria35 (except for healthy control subjects). Severity of AD will be based on an investigator's global assessment score (IGA).
- 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
- Women of child bearing potential 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.
- All subjects in Groups 1 and 3 will be required to cease use of oral antihistamines for a period of one week prior to and during the study visit.
- Subjects in Groups 1 and 3 must cease using topical agents on the forearm where experimentation is going to be performed at least 1 week prior. Topical agents can be used in all other parts of the body.
- Baseline COVAS ratings of more than 9/100 after histamine iontophoresis at the screening visit
Who cannot join
- Adults over age 65
- Children less than 18 years of age
- Unable to complete the required measures
- Currently enrolled in any investigational study in which the subject is receiving any type of drug, biologic, or non-drug therapy and subjects undergoing treatment with another investigational drug or approved therapy for investigational use within 28 days prior to study participation
- Consumption of more than 4 caffeinated beverages per day
- Current treatment with oral lipophilic beta blockers, opioids, glucocorticoids, theophylline, antihistamines or other medications known to interfere with itch perception or heart rate variability as determined by the investigators
Show all 19Show fewer
- Uncontrolled asthma or COPD
- Uncontrolled thyroid disease
- Poorly controlled diabetes mellitus
- Poorly compensated congestive heart failure
- Use of illicit drugs
- History of chronic urticaria
- History of anaphylactic shock
- History of neuropathy causing disease such as diabetes and uremia
- Allergy to histamine
- Blindness
- Baseline COVAS ratings of less than 9/100 after histamine iontophoresis at the screening visit
- Subject participation in more than one group.
- Positive pregnancy test
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
The purpose of this research study is to assess whether seeing other people itch affects itch perception in patients with atopic dermatitis and healthy subjects.
Read the detailed description
The objectives of this study are to quantitatively assess the effect of visual stimuli on perception of itch and to assess if visual stimuli affect individuals with atopic dermatitis differently than healthy people.
- Conditions
- Atopic Dermatitis
- Medical subject headings
- Dermatitis, Atopic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2008 (estimated)
- Study startOct 2007
- 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.
- More trials run by Wake Forest University Health SciencesThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- 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
- NCT00660127
- Sponsor's protocol ID
- 00002112
- Other IDs
- 32018
- Status last verified
- Apr 2008
- First submitted
- 10 Apr 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
- The Effect of Visual Stimuli on Itch Perception Intensity in Healthy and Atopic Dermatitis Patients
- ClinicalTrials.gov ID
- NCT00660127
- Acronym / sponsor ID
- 00002112
- Conditions
- Atopic Dermatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 17 Apr 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 study is to assess whether seeing other people itch affects itch perception in patients with atopic dermatitis and healthy subjects.
Detailed description
The objectives of this study are to quantitatively assess the effect of visual stimuli on perception of itch and to assess if visual stimuli affect individuals with atopic dermatitis differently than healthy people.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- general community population
Key inclusion criteria (7 listed)
- Adult men and women who are between 18 and 65 years of age
- Diagnosis of moderate to severe atopic dermatitis including involvement of the forearm confirmed by published consensus diagnostic criteria35 (except for healthy control subjects). Severity of AD will be based on an investigator's global assessment score (IGA).
- 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
- Women of child bearing potential 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.
- All subjects in Groups 1 and 3 will be required to cease use of oral antihistamines for a period of one week prior to and during the study visit.
Key exclusion criteria (19 listed)
- Adults over age 65
- Children less than 18 years of age
- Unable to complete the required measures
- Currently enrolled in any investigational study in which the subject is receiving any type of drug, biologic, or non-drug therapy and subjects undergoing treatment with another investigational drug or approved therapy for investigational use within 28 days prior to study participation
- Consumption of more than 4 caffeinated beverages per day
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
Not reported in the source record.
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.
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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.
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 Health Sciences 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 7 inclusion and 19 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.
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.