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The Effect of Visual Stimuli on Itch Perception Intensity in Healthy and Atopic Dermatitis Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00660127
First Posted: April 17, 2008
Last Update Posted: March 16, 2017
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.
Information provided by (Responsible Party):
Wake Forest University Health Sciences
April 10, 2008
April 17, 2008
March 16, 2017
October 2007
December 2009   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00660127 on ClinicalTrials.gov Archive Site
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The Effect of Visual Stimuli on Itch Perception Intensity in Healthy and Atopic Dermatitis Patients
The Effect of Visual Stimuli on Itch Perception Intensity in Healthy and Atopic Dermatitis Patients
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.
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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
general community population
Atopic Dermatitis
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
December 2009
December 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00660127
00002112
32018
No
Not Provided
Not Provided
Wake Forest University Health Sciences
Wake Forest University Health Sciences
Not Provided
Principal Investigator: Gil Yosipovitch, MD Wake Forest University Health Sciences
Wake Forest University Health Sciences
April 2008