Antipruritic Effect of Acupuncture in Patients With Atopic Dermatitis

NCT02844452 | Completed DMC

• 1 other identifier: KOMCIRB-160212-HRBR-004
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Atopic Dermatitis; acupuncture; visit frequency; adult patient with AD

Outcome Measures

Primary Outcomes (3)

• Itch VAS

  The itch VAS is one of components of SCORAD index, and it will be particularly applied to assess the severity and alleviation of atopic dermatitis in this trial. The AD patients whose itch VAS scores less than 30 or more than 80 will be excluded because of their lower desire for anti-pruritic therapy or requirement of more potent treatment 13. The change of itch VAS through the trial will be used to classify as responders or non-responders of the acupuncture treatment.

  Baseline, 1-week, 2-week, 3-week, 4-week, and 8-week

• SCORAD index

  SCORAD is a well-known tool for assessing the severity of atopic dermatitis. The SCORAD contains evaluation of the intensity and extent of affected region and estimation of subjective discomforts, such as pruritus and sleep loss symptom 10-12. SCORAD index contains 6 items to evaluate intensity of atopic dermatitis: erythema, exoriation, edema or papulation, lichenification, oozing or crust, and dryness. The extent of lesion is assessed as percentage of entity. One same KMD will grade the intensity and extent of affected skin and a patient will check their subjective symptoms with visual analogue scale (0 = no itch or sleep loss, 10 = worst imaginable itch or sleep loss). The change from baseline SCORAD index at 4 weeks will be analyzed as the primary outcome measure.

  Baseline, 1-week, 2-week, 3-week, 4-week, and 8-week

• EASI score

  EASI is a validated instrument measuring the severity of atopic dermatitis 12 14. It is composed of distribution of four body regions and four signs of AD: head and neck, trunk, upper extremities, and lower extremities for body regions and erythema, edema/papulation, excoriation, and lichenification for signs of atopic dermatitis. One same KMD will grade the severity of atopic dermatitis with EASI score. The change from baseline EASI score at 4 weeks will be analyzed as the primary outcome measure.

  Baseline, 1-week, 2-week, 3-week, 4-week, and 8-week

Secondary Outcomes (2)

• POEM

  Baseline, 1-week, 2-week, 3-week, 4-week, and 8-week

• DLQI

  Baseline, 1-week, 2-week, 3-week, 4-week, and 8-week

Study Arms (4)

Verum Acupuncture 1

EXPERIMENTAL

The participants with atopic dermatitis in the acupuncture group 1 will attend twelve acupuncture sessions over 4 weeks: 3 days a week. Once the 4-week treatment period was ended, the additional follow-up period will be conducted. The subjects will stand a final visit 4 weeks from the end of treatment period. Any other intervention will not be allowed during this study period.

Device: Acupuncture

Verum Acupuncture 2

EXPERIMENTAL

The participants with atopic dermatitis in the acupuncture group 2 will attend eight acupuncture sessions over 4 weeks: 2 days a week. Once the 4-week treatment period was ended, the additional follow-up period will be conducted. The subjects will stand a final visit 4 weeks from the end of treatment period. Any other intervention will not be allowed during this study period.

Device: Acupuncture

Sham Acupuncture

SHAM COMPARATOR

The participants in the sham acupuncture group will visit eight acupuncture sessions over 4 weeks. The acupuncture treatment will be conducted on six control points. The acupressure will be applied with ring-sham press tack needles on three control points. Unlike the acupuncture group 2, partially-individualized manual acupuncture according to the patient's symptoms will not be given but the questions about symptoms will be questioned to patients.

Device: Sham Acupuncture

Healthy Control

NO INTERVENTION

The participants will go through the screening test. The included subjects will complete questionnaires and their blood sample will be obtained.

Interventions

Acupuncture DEVICE

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.

Verum Acupuncture 1; Verum Acupuncture 2

Sham Acupuncture DEVICE

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.

Sham Acupuncture

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals over age 19
• Individuals who meet the Hanifin \& Rajka and whose AD symptoms express constantly
• Individuals who check more than 3 points and less than 8 points on the visual analogue scale for atopic dermatitis (with a total score out of 10)
• Individuals who are graded 10 to 40 points on the SCORAD index
• Individuals who have not taken the subscribed medicines for atopic dermatitis recent one month.
• Individuals who understand this study protocol and voluntarily agree with participation.
• Individuals who have not participated any other researches recent one month

You may not qualify if:

• Individuals whose modalities of atopic dermatitis change unpredictably
• Individuals who receive inappropriate therapies such as oral corticosteroids which affect the outcomes
• Individuals who also have asthma, bronchitis or other sever psychological disorders
• Individuals who have other inappropriate disorders affecting the outcomes

Sponsors & Collaborators

• Kyunghee University: lead

Study Sites (1)

Kyung Hee University Korean Medicine Hospital

Seoul, 02447, South Korea

Location

Related Publications (1)

• Kim YK, Yeom M, Kang S, Park HJ, Kim K, Lee H. Antipruritic Effect of Acupuncture in Patients with Atopic Dermatitis: Feasibility Study Protocol for a Randomised, Sham-Controlled Trial. Evid Based Complement Alternat Med. 2017;2017:1926806. doi: 10.1155/2017/1926806. Epub 2017 Nov 14.

  PMID: 29358961 DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Acupuncture Therapy

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Kyuseok Kim, PhD, DKM

  Kyung Hee University Korean Medicine Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: July 15, 2016
• First Posted: July 26, 2016
• Study Start: September 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: April 17, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)