Acupressure in Pruritus for Atopic Dermatitis

NCT01074164 | Completed Results DMC

• 1 other identifier: STU 20535
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see if acupressure will be effective at reducing itch in people with atopic dermatitis (AD).

Conditions

Atopic Dermatitis

Keywords

eczema; atopic dermatitis; itch; pruritus; acupressure; acupuncture

Outcome Measures

Primary Outcomes (1)

• Change in Itch Intensity as Measured by a Change in Visual Analog Scale (VAS) Score

  The VAS score assesses itch intensity in subject's with AD. The VAS consists of a 21.5 cm horizontal line with its left and right boundaries marked by vertical lines. The left boundary vertical line is labeled "Least Itch," and the right boundary vertical line is labeled "Worst Itch." Subjects are instructed to draw a vertical line across this scale that represents the intensity of itch that they are currently experiencing. Vertical lines drawn by subjects towards the left boundary of the horizontal line are associated with less itch intensity, and vertical lines drawn by subjects towards the right boundary of the horizontal line are associated with worse itch intensity. A ruler is then used to measure distance from the left boundary vertical line to the vertical line drawn by the subject to the nearest millimeter. Possible values range from 0 to 21.5 centimeters, with 0 centimeters associated with less itch intensity and 21.5 cm associated with worse itch intensity.

  Baseline and 4 weeks

Secondary Outcomes (6)

• Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Investigator Global Assessment (IGA) Score

  Baseline and 4 weeks

• Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Eczema Area and Severity Index (EASI): Area Subscale Score

  Baseline and 4 weeks

• Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Eczema Area and Severity Index (EASI): Erythema Subscale Score

  Baseline and 4 weeks

• Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Eczema Area and Severity Index (EASI): Infiltration/Papulation Subscale Score

  Baseline and 4 weeks

• Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Eczema Area and Severity Index (EASI): Excoriation Subscale Score

  Baseline and 4 weeks

Study Arms (2)

Control group

PLACEBO COMPARATOR

This group of subjects will serve as the control group and will follow a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids.

Other: Standard-of-care treatment for AD

Accu-patch pellet

EXPERIMENTAL

This group of subjects will follow a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids. Additionally, they will use a titanium pellet (accu-patch pellet) to self-apply pressure at the LI11 acupuncture pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times weekly for 1 month.

Device: Accu-patch pellet

Interventions

Standard-of-care treatment for AD OTHER

Subjects will receive standard of care treatment for atopic dermatitis, including moisturizers and topical corticosteroids, per their dermatologist.

Control group

Accu-patch pellet DEVICE

The accu-patch pellets will be applied to the LI11 pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times a week for 1 month.

Accu-patch pellet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of AD by dermatologist
• Not currently using acupressure or acupuncture for treatment of AD
• Able to read, write, and understand study materials
• Age 18 or older

You may not qualify if:

• Unable to physically perform acupressure technique
• Significant comorbidities causing itch such as chronic urticaria, renal failure, notalgia paresthetica, and tinea

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema; Pruritus

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Mandy Browning
• Organization: Northwestern University Department of Dermatology

mandybrowning2015@u.northwestern.edu

312-695-6829

Study Officials

• Dennis West, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Dermatology and Pediatrics

Study Record Dates

• First Submitted: February 22, 2010
• First Posted: February 24, 2010
• Study Start: February 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: January 5, 2015
• Results First Posted: January 16, 2013

Record last verified: 2014-12

Locations

US (1)