A Comparative Study on the Efficacy and Safety of Biodegradable Microneedle Acupuncture and Conventional Intradermal Acupunture for Atopic Dermatitis

A Comparative Investigator-initiated Pilot study on the Efficacy and Safety of Biodegradable Microneedle Acupuncture and Conventional Intradermal Acupunture for Atopic Dermatitis: A Non-inferiority, Assessor-blinded, Randomized Controlled Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0007546

Enrollment

Registered

2022-07-25

Start date

2022-05-19

Completion date

Unknown

Last updated

2022-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : Through randomization, total 30 atopic dermatitis patients are equally divided into the biodegradable microneedle acupuncture group and the intradermal acupuncture group. Biodegradabl

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Participants should meet all of the following criteria; (1) Male and female patients aged 19-60 at the screening visit. (2) Atopic dermatitis patients diagnosed by Hanifin and Rajka criteria and have dry skin. Atopic dermatitis can be diagnosed if the patient has more than 3 of 4 major symptoms and 3 of 23 minor symptoms in the Hanifin and Rajka criteria. (3) Patients who have 2 similar dry skin lesions in order to compare the efficacy of biodegradable microneedle patch with normal patch. (4) Patients who submitted written consent voluntarily.

Exclusion criteria

Exclusion criteria: The patient who meets any of the following criteria cannot participate in; (1) Patients who were taking intensive medication. (2) Patients who used oral antibiotics, oral steroids, or immunosuppressants within 4 weeks before this study begins. (3) Atopic dermatitis symptoms are too changeable. (4) Secondary infection on the atopic dermatits lesion. (5) Patients taking interferon medication, including interferon-alpha and interferon-beta. (6) Liver patients, including cirrhosis or liver cancer. (7) Kidney patients, including acute/chronic renal failure, or nephrotic syndrome. (8) Severe acute cardiovascular patients including heart failure, myocardial infarction, or stroke. (9) Patients who took antipsychotics within 3 months before screening. (10) Patients who have an allergy to adhesives. (11) Patients vulnerable to infection provoked by acupuncture because of atopic dermatitis lesion on the treatment acupoints. (12) Pregnant, lactating women, or women planning pregnancy. (13) Others who principal investigator decided inadequate.

Design outcomes

Primary

Measure	Time frame
Objective scoring atopic dermatitis (SCORAD) index	—

Secondary

Measure	Time frame
Change in visual analogue scale (VAS) for pruritus;Change in the VAS for insomnia;Change in the Dermatology Life Quality Index (DLQI) score;Change in skin hydration;Change in transepidermal water loss (TEWL)	—

Countries

Korea, Republic of

Contacts

Public ContactJi-Hoon Song

Dongshin University

kmdsjh0122@nate.com+82-61-338-7811

Outcome results