- Research purpose and background
 The purpose of this study is to investigate the effect of acupuncture treatment on mild to moderate adult atopic dermatitis. Although studies about the effects of acupuncture treatment on atopic dermatitis have been reported, most of them have been studied in combination with other therapies rather than acupuncture alone. Therefore, it is necessary to clarify the effect of acupuncture alone on atopic dermatitis. The number of subjects was calculated through the preliminary research conducted by the research team, and the research will be conducted based on the results.

-theory
H0: Verum acupuncture(VA) group and Sham acupuncture(SA) group showed no difference in SCORAD total score change just before treatment (at baseline) and after treatment (at 4 weeks).
H1: VA group and SA group differ in SCORAD total score change immediately before treatment (at baseline) and after treatment (at 4 weeks).

-clinical research plan
 This study is conducted to investigate the improvement effect of acupuncture treatment for atopic dermatitis. Among the patients participating in the study, the patients assigned to the VA group received acupuncture treatment for the basic acupoint which is proved to be effective for atopic dermatitis. Depending on the person's symptoms, additional acupuncture treatment can be performed. 
In the VA group, all patients will get acupuncture treatment at PC6, LI11, ST36 bilaterally for 15minutes. Depending on patients’ symptoms, additional acupuncture treatment can be operated. The patient will be treated with  press needles at LI11 bilaterally and yishenmen at contralaterally. If severe itching occurs in daily life, the patient is instructed to press the press needles.
 Patients assigned to the SA group receive acupuncture treatment on other similar acupoints. 
 All patients participating in this study will be asked to fill out a questionnaire to evaluate symptoms of atopic dermatitis and symptoms related to dyspepsia during the study.
 During the study period, the patient is principally prohibited from taking drugs and other treatments to improve atopic dermatitis.

Treatment

Acupuncture treatment is based on the recommendations of the revised Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) 2010. Manual acupuncture and intradermal acupuncture will be performed for all participants. All acupuncture treatment will be administered by the same Korean Medicine Doctor (KMD). KMD who conducts acupuncture treatment has more than 2 years clinical experience and will be trained more than 10 hours to perform the same acupuncture treatment as the predefined protocol.

Participants in the VA will receive 8 acupuncture treatments twice a week for a total of four weeks. All VA patients will receive acupuncture treatment for 6 acupoints. Acupuncture treatment for up to 10 additional acupoints will be performed for each participant. The six fixed acupoints are: LI11, ST36 and PC6 bilaterally. Additional acupoints are: ST43, GB41, LI2, TE3, SI3, TE6, SI2, BL66, LR3, SP3. ST43 and GB41 for gastric stuffiness or dyspepsia; LI2 and GB41 for tenderness around ST25, diarrhoea, or constipation; TE3 and SI3 for fullness in the chest and hypochondrium; TE3 and TE6 for lower abdominal pain and tenderness on the chest center; SI3 and GB41 or SI2 and BL66 for lower abdominal pain, dry skin, or heat in the upper body and cold in the lower body; and LR3 and SP3 for pain in the hypogastric region with darkness of the sublingual collateral vessels. Acupuncture treatment will be performed using a Park Sham device to maintain participant blindness. Disposable sterile stainless needles (40 mm length, 0.25 mm diameter; Dongbang Acupuncture Inc., Bundang, Seongnam, Korea) will be used for needle treatment. The acupuncture will be inserted up to 5 to 30 mm depending on the acupoints and will be remained for 15 minutes.
After acupuncture removal, 3 acupoints were treated with intradermal acupuncture using 1.5 mm press tack needles (Haeng Lim Seo Won Medical Co., Korea). The acupoint is: LI11 bilaterally, auricular-Shenmen contralaterally. Participants will be instructed by the researchers to press LI11 for three minutes if they experience severe itching.

Participants in the SA will receive Sham acupuncture treatment eight times  twice a week for a total of four weeks. After a break for more than 5 minutes, sham acupuncture treatment is performed. Unlike the VA group, Sham acupuncture treatment is performed only on 6 control points. The acupoints are as follows: a point 1 to 2 cm proximal and 1 cm medial to LI 7, a point 1 cm proximal and 1 cm medial to LI 11, and a point 1 cm proximal and 1 cm lateral to ST 36, each bilaterally. Sham acupuncture treatment will be performed using a Park Sham device to maintain participant blindness. Park sham acupuncture needles (AcuPrime Co., Ltd., Exeter, UK) will be used for sham acupuncture treatment and will last for 15 minutes.
 After removal of the needles, instead of intradermal needles, needle-free, stainless steel rings of the same size, which do not pierce the skin, will be attached to the three control points. The control points are: 1 cm proximal and 1 cm medial to LI11, bilaterally, and finger point in the ear, contralaterally. Unlike the VA group, the SA group will not be instructed to press the control point.

Arm Label

Target Number of Participant

Arm Type

Arm Description

Participants in the VA will receive 8 acupuncture treatments twice a week for a total of four weeks. All VA patients will receive acupuncture treatment for 6 acupoints. Acupuncture treatment for up to 10 additional acupoints will be performed for each participant. The six fixed acupoints are: LI11, ST36 and PC6 bilaterally. Additional acupoints are: ST43, GB41, LI2, TE3, SI3, TE6, SI2, BL66, LR3, SP3. ST43 and GB41 for gastric stuffiness or dyspepsia; LI2 and GB41 for tenderness around ST25, diarrhoea, or constipation; TE3 and SI3 for fullness in the chest and hypochondrium; TE3 and TE6 for lower abdominal pain and tenderness on the chest center; SI3 and GB41 or SI2 and BL66 for lower abdominal pain, dry skin, or heat in the upper body and cold in the lower body; and LR3 and SP3 for pain in the hypogastric region with darkness of the sublingual collateral vessels. Acupuncture treatment will be performed using a Park Sham device to maintain participant blindness. Disposable sterile stainless needles (40 mm length, 0.25 mm diameter; Dongbang Acupuncture Inc., Bundang, Seongnam, Korea) will be used for needle treatment. The acupuncture will be inserted up to 5 to 30 mm depending on the acupoints and will be remained for 15 minutes.
After acupuncture removal, 3 acupoints were treated with intradermal acupuncture using 1.5 mm press tack needles (Haeng Lim Seo Won Medical Co., Korea). The acupoint is: LI11 bilaterally, auricular-Shenmen contralaterally. Participants will be instructed by the researchers to press LI11 for three minutes if they experience severe itching.

Arm Label

Target Number of Participant

Arm Type

Arm Description

Participants in the SA will receive Sham acupuncture treatment eight times twice a week for four weeks. After a break for more than 5 minutes, sham acupuncture treatment is performed. Unlike the VA group, Sham acupuncture treatment is performed only on 6 control points. The acupoints are as follows: a point 1 to 2 cm proximal and 1 cm medial to LI 7, a point 1 cm proximal and 1 cm medial to LI 11, and a point 1 cm proximal and 1 cm lateral to ST 36, each bilaterally. Sham acupuncture treatment will be performed using a Park Sham device to maintain participant blindness. Park sham acupuncture needles (AcuPrime Co., Ltd., Exeter, UK) will be used for sham acupuncture treatment and will last for 15 minutes.
 After removal of the needles, instead of intradermal needles, needle-free, stainless steel rings of the same size, which do not pierce the skin, will be attached to the three control points. The control points are: 1 cm proximal and 1 cm medial to LI11, bilaterally, and finger point in the ear, contralaterally. Unlike the VA group, the SA group will not be instructed to press the control point.

Gender

Age

Description

*Participants who meet all of the following criteria will be included:
A. Men and women aged 19 to 64
B. Patients with atopic dermatitis diagnosed according to Hanifin & Rajka criteria
C. Patients who were between 30 points and 80 points on the 100mm Pruritus Visual Analog Scale (VAS)
D. Objective SCORAD scores between 10 and 40 points
E. Patients who have not taken prescribed medicines related to Atopic dermatitis for the past month
F. Understanding the purpose of this study and agreeing to participate
G. Patients who have not participated in other clinical studies for the past month

Participants who meet any of the following criteria will be excluded:
A. Severely fluctuating Atopic Dermatitis symptoms
B. patients who receive other treatments(e.g. oral steroids) that may affect Atopic dermatitis or that research doctor thought to be inappropriate
C. Patients with secondary infection at lesions of atopic dermatitis
D. Patients with severe mental illness symptoms
E. Pregnant women or those with a pregnancy plan during the study period or those who are lactating.
F. Patients with a medical history that the Korean medicine doctor considers to be inadequate.

Scoring Atopic Dermatitis(SCORAD) Index

at screening visit(0 week), 2nd,4,6,8th visit, last follow up visit

Eczema Area Severity Index(EASI)

1st, 2nd ,4,6,8th visit, last follow up visit(8wk)

Patient Oriented Eczema Measure(POEM)

1st, 2nd ,4,6,8th visit, last follow up visit.

Dermatology Life Quality Index(DLQI)

1st, 2nd ,4,6,8th visit, last follow up visit(8wk)

Abdominal examination using Pressure Pain Threshold algometer(PPT)

at 1st, 4th, 8th visit.

Nepean Dyspepsia Index-Korean version(NDI-K)

at screening visit(0 week), 8th visit(after treatment session ends), and last follow up visit(8wk)

Adequate Relief of Functional dyspepsia pain and discomfort

at 5th(3week), 8th(4week) visit, Telephone visit(6week), and last follow up visit(8wk)

Visual Analog Scale about Dyspepsia symptoms

at screening visit(0 week), 2nd,4,6,8th visit, Telephone visit(6wk), last follow up visit(8wk)

Credibility Test

at screening visit(0 week), 8th visit, last follow up visit(8wk)

Blinding Test

at 8th visit(after the treatment session ends, 4wk. )

Electroencephalogram(EEG)

1st, 8th visit.