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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gil Yosipovitch, Wake Forest University
ClinicalTrials.gov Identifier:
NCT00660127
First received: April 10, 2008
Last updated: August 8, 2012
Last verified: April 2008
  Purpose

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.


Condition
Atopic Dermatitis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Effect of Visual Stimuli on Itch Perception Intensity in Healthy and Atopic Dermatitis Patients

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Enrollment: 25
Study Start Date: October 2007
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

general community population

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00660127

Locations
United States, North Carolina
Wake Forest University Health Sciences Dermatology
Winston Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest School of Medicine
Investigators
Principal Investigator: Gil Yosipovitch, MD Wake Forest School of Medicine
  More Information

No publications provided

Responsible Party: Gil Yosipovitch, Professor, Wake Forest University
ClinicalTrials.gov Identifier: NCT00660127     History of Changes
Other Study ID Numbers: 00002112, 32018
Study First Received: April 10, 2008
Last Updated: August 8, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 28, 2014