Patients with atopic dermatitis (AD) and erythematous skin disease are often treated with topical treatment containing corticosteroids. However, long term use of topical corticosteroid is well known for its potential side-effects such as skin atrophy, hirsutism, dyspigmentation, telangiectasia, and possible skin infection and iatrogenic adrenal insufficiency. Fear about medication side effects would cause lack of adherence to treatment regiments and thus patients would seek for alternative therapies, and a long term safer and affordable treatment modality is required to fill this therapeutic gap.
Enhanced external counter-pulsation (EECP) therapy is a non-invasive method to improve perfusion of vital organs and reduces hypercholesterolemia-induced endothelial damage. It also helped to increase cerebral blood circulation in patients with ischemic stroke and improved neurological recovery.
This study aim to evaluate the efficacy and safety of patients with atopic dermatitis and erythematous/ inflammatory skin diseases to receive EECP therapy combined treatment compared to wet wrap therapy alone.
Patients aged between 18 to 65 years old present with atopic dermatitis or erythematous / inflammatory skin diseases attending Queen Mary Hospital dermatology clinics requiring wet-wrap therapy (WWT) will be screened for recruitment by attending dermatologist(s)
Patients with AD having EASI>10 or erythematous/inflammatory skin disorder BSA>5%
Body weight ≥ 40kg at screening and baseline visit
Body height ≥ 150cm at screening and baseline visit
Patients who refuse to give consent
Females of childbearing potential who are pregnant or during breastfeeding period
Patients have newly started systemic corticosteroid, immunosuppressants or biologics within 6 week of Baseline (Day 0)
Patients who have unstable AD or inflammatory skin disease, active infection or contagious skin symptoms within 2 weeks before day 1 pre-enrolment
Crossover
wet wrap therapy
Procedure/SurgerySteps for wet wrap therapy After bath/shower with emollients, pat to remove excess water on body and apply the emollient and/ or steroid cream liberally on the affected area to enhance water absorption and seal in moisture Put wet wrap garment in lukewarm water, squeeze water out of the wet wrap garment, take them out without dribbling of water and then apply on the affected area Put on another layer of dry garments/ warm clothing to cover the wet wrap garments and wear usual clothing as needed Check regularly and keep the wet wrap garments underneath damp with water sprayer or wet towel if necessary Patient is suggested to apply emollients frequently throughout the day to maintain the effect
External compression counter-pulsation (EECP)
DeviceExternal compression counter-pulsation (EECP) is a compression/decompression non-invasive device (Stendo Pulsewave ® V3 CE certificate class IIa) used for lower part of the body (legs, thighs and buttock/hips) to reproduce and stimulate the natural physiological pulsations and the physical shear stress force.
EECP therapy treatment should have more superior result compared to those receiving WWT alone
Patients with atopic dermatitis +/- erythematous/inflammatory skin disorders receiving EECP therapy treatment should have more mean reduction of total Eczema Area and Severity Index (EASI) score from baseline to Day 7 compared to those receiving WWT alone. EASI score ranges from 0-72, and higher scores mean a worse outcome.
achieve EASI 25%/ 50%/ 75% reduction on Day 7
1\. Percentage of participants who achieve EASI 25%/ 50%/ 75% reduction on Day 7 (after the first week of treatment)
second week of treatment and achieve EASI 25%/ 50%/ 75% reduction on Day 14
2\. Percentage of subjects who receive the second week of treatment and achieve EASI 25%/ 50%/ 75% reduction on Day 14 after the second week of treatment
at least 2 points decrease of itch score/sleep score decrease from Baseline visit
3\. Percentage of participants who have at least 2 points decrease of itch score/sleep score decrease from Baseline visit to Day 7 and or day 14 and 4 weeks- post treatment
least 2-point vIGA/ PGA decrease from baseline
4\. Percentage of participants who receive the second week of treatment and achieve at least 2-point vIGA/ PGA decrease from baseline 50% reduction comparing to Day 14
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