A Comparative Study on the Efficacy and Safety of Biodegradable Microneedle Acupuncture and Conventional Intradermal Acupunture for Atopic Dermatitis
- Conditions
- Diseases of the skin and subcutaneous tissue
- Registration Number
- KCT0007546
- Lead Sponsor
- aju Dongshin University Korean Medicine Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
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.
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.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective scoring atopic dermatitis (SCORAD) index
- Secondary Outcome Measures
Name Time Method 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)