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Cooling Pillow for Atopic Dermatitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dennis West, Northwestern University
ClinicalTrials.gov Identifier:
NCT01132651
First received: May 26, 2010
Last updated: December 10, 2012
Last verified: December 2012
History of Changes
  Purpose

The purpose of this study is to see if using a cooling pillow at night will help sleep quality in people with atopic dermatitis (AD).


Condition Intervention
Atopic Dermatitis
Eczema
 Other: Current standard eczema treatment and standard pillow at night
Other: Chillow cooling pillow

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Novel Use of a Cooling Pillow for Treatment of Severe Hand and Neck Atopic Dermatitis

Resource links provided by NLM:

MedlinePlus related topics: Eczema Itching
U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Change in Sleep Quality as Measured by a Change in Pittsburgh Sleep Quality Index (PSQI) Survey Score [ Time Frame: Baseline and at 2 weeks ] [ Designated as safety issue: No ]

    The PSQI is a clinical survey used to measure sleep quality. Seven components related to sleep quality are scored: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. Each component is scored on a scale of 0 to 3. A score of 0 is associated with better sleep quality and a score of 3 is associated with worse sleep quality. The seven component scores are summed to achieve a total PSQI score. The total PSQI score has a range of 0-21. A score of 0 is associated with better sleep quality and a score of 21 is associated with worse sleep quality.

    Buysse,D.J., Reynolds,C.F., Monk,T.H., Berman,S.R., & Kupfer,D.J. (1989). The Pittsburgh Sleep Quality Index (PSQI): A new instrument for psychiatric research and practice. Psychiatry Research, 28(2), 193-213.



Secondary Outcome Measures:
  • Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Investigator Global Assessment (IGA) Score [ Time Frame: Baseline and at 2 weeks ] [ Designated as safety issue: No ]
    The IGA score is an assessment of AD severity. It is an assessment of the patient's disease state at the time of examination and does not attempt a comparison with any of the patient's previous disease states. Possible scores range from 0 to 5. A score of 0 is associated with no evidence of AD and a score of 5 is associated with severe AD.


Enrollment: 9
Study Start Date: May 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chillow cooling pillow
This group of subjects will follow their current eczema regimen with the addition of using the cooling pillow at night to sleep on.
 Other: Chillow cooling pillow
Subjects will use the cooling pillow to sleep on in addition to their current eczema treatment for 2 weeks.
Placebo Comparator: Standard of care (regular pillow at night)
This group of subjects will serve as the control group following a their current eczema care regimen, including sleeping on their normal pillow.
 Other: Current standard eczema treatment and standard pillow at night
Subjects will continue with their current eczema care and use their normal pillow at night.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of AD by dermatologist
  • AD located on the head and neck
  • Investigator Global Assessment (IGA)score >3 at time of enrollment
  • Able to read, write, and understand study materials
  • Age 18 or older

Exclusion Criteria:

  • Concurrent non-AD skin disease on the head and neck
  • Active skin infection on the head and neck, or conditions that may interfere with evaluation of the skin
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01132651

Locations
United States, Illinois
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Dennis West, PhD Northwestern University
  More Information

No publications provided

Responsible Party: Dennis West, Professor in Dermatology and Pediatrics, Northwestern University
ClinicalTrials.gov Identifier: NCT01132651     History of Changes
Other Study ID Numbers: STU 28933
Study First Received: May 26, 2010
Results First Received: July 30, 2012
Last Updated: December 10, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
eczema
itch
pruritus
head
neck

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

ClinicalTrials.gov processed this record on May 16, 2013