Antipruritic Effect of Acupuncture in Patients With Atopic Dermatitis

Summary

Introduction: Atopic dermatitis (AD) is a chronic relapsing inflammatory skin disease inducing poor quality of life. Its conventional treatments often cause unsatisfactory relief and adverse effects in long-term application. Acupuncture treatment is regarded to have a curative effect on AD symptoms. The aim of this trial is to evaluate the therapeutic effects of acupuncture on AD symptoms including pruritus and poor quality of life in patients with AD.

Method and Analysis: This trial is a randomized, sham-controlled pilot trial with different visit frequencies. 30 eligible patients with atopic dermatitis will be randomly allocated in a ratio of 1:1:1 to the Verum Acupuncture group 1 (VA1, 3 days weekly), Verum Acupuncture group 2 (VA2, 2 days weekly) and Sham Acupuncture group (2 days weekly). The acupuncture treatment will be given three or two times a week for 4 weeks according to the allocated groups. The main outcome measures are Visual analogue scale for itch (itch VAS), SCORing Atopic Dermatitis (SCORAD) and Eczema Area and Severity Index (EASI) to evaluate the improvement of AD symptoms and Patient Oriented Eczema Measure (POEM), Dermatology Life Quality Index (DLQI) to assess the quality of life of AD patients. It will be measured at baseline, once a week during treatment period and after follow-up period.

Ethics/Dissemination: This protocol was approved by the Institutional Review Boards at Kyung Hee University Korean Medicine Hospital on May 2016. The permission number is KOMCIRB-160212-HRBR-004. This trial will provide the data of therapeutic effects of treating atopic dermatitis with acupuncture in accordance with the different visit frequencies. The outcomes will be facilitated to calculate the sample size of further study with the same design of this study. The findings from this trial will be published and presented in conference.

Conditions

• Atopic Dermatitis

Interventions

DEVICE

Acupuncture

Acupuncture is a form of alternative medicine and a key component of traditional Korean medicine (TKM) involving thin needles inserted into the body at acupuncture points. It can be associated with the application of heat, pressure, or laser light to these same points. Acupuncture is commonly used for pain relief, though it is also used for a wide range of other conditions. Clinical practice varies depending on the country.

DEVICE

Sham Acupuncture

Sham acupuncture is used as a control in scientific studies that test the efficacy of acupuncture in the treatment of various illness or disorders. In an ideal controlled study, subjects would not know whether they were getting true or sham acupuncture. We are going to use Park Sham Acupuncture, which is composed of sham acupuncture needle not penetrating the skin of subjects and Park sham acupuncture device attacted on the subject's skin in order to block the seeing whether the acupuncture needle penetrates skin or not.

Sponsors & Collaborators

• Kyunghee University

  lead OTHER

Principal Investigators

• Kyuseok Kim, PhD, DKM · Kyung Hee University Korean Medicine Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

19 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-09-30

Primary Completion

2017-04-30

Completion

2017-04-30

Countries

• South Korea

Study Locations