The Safety and Efficacy of Microneedle Patch for Ameliorating Dry Skin in Atopic Dermatitis
- Conditions
- Diseases of the skin and subcutaneous tissue
- Registration Number
- KCT0005942
- Lead Sponsor
- aju Dongshin University Korean Medicine Hospital
- Brief Summary
1. The biodegradable hyaluronic acid microneedle (BHMN) patch combination therapy significantly improved the L-SCORAD index compared with topical medication alone. 2. For VAS score, the BHMN patch combination therapy significantly improved the VAS for skin dryness compared with topical medication alone. However, the BHMN patch combination therapy did not show superiority over the control treatment in the VAS for pruritus. 3. The BHMN patch combination therapy significantly increased skin hydration compared with the control treatment. 4. In addition, the SCORAD index and DLQI also significantly improved, which reflects the improvement in QoL of the participants. 5. Considering that there were no adverse events during the trial, the BHMN patch can be determined to be a safe medical device.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 20
(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 areas at the limbs in order to compare the efficacy of solitary local external preparation application with combination therapy of local application and soluble microneedle patch.
(4) Patients who submitted written consent voluntarily.
(1) Patients who were taking intensive medication such as antihistamines or steroids.
(2) Patients who used oral antihistamines, oral antibiotics, oral or topical steroids, systemic photochemotherapy, or other immunosuppressants within 4 weeks before this study begins.
(3) Patients having systemic infection or taking systemic antibiotic therapy.
(4) Patients having other severe skin diseases except atopic dermatitis.
(5) Patients taking interferon medication.
(6) Liver patients including cirrhosis or liver cancer.
(7) Kidney patients including acute or 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) Patient who are sensitive to natural products.
(11) Patients who have an allergy to adhesives.
(12) Pregnant or nursing women.
(13) Severe oozing or maceration.
(14) Others who investigators decided inadequate.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in skin lesion comparing photos on the 2nd week with the baseline;Change in L-SCORAD index on the 2nd week from the baseline
- Secondary Outcome Measures
Name Time Method Change in investigator's global assessment(IGA) score on the 2nd week from the baseline;Change in total SCORAD index on the 2nd week from the baseline;Change in DLQI score on the 2nd week from the baseline;Change in VAS score for pruritus on the 2nd week from the baseline;Change in VAS score for skin dryness on the 2nd week from the baseline;Change in skin hydration on the 2nd week from the baseline;Change in transepidermal water loss(TEWL) on the 2nd week from the baseline;Change in participant's satisfaction on the 2nd week from the baseline