Evaluation of Efficacy and Safety of Enhanced External Counter-pulsation on Patients With Atopic Dermatitis and Inflammatory Skin Disease Requiring Wet Wrap Therapy

NCT06448702 | Not Yet Recruiting

• 1 other identifier: HKWC-2024-295
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Atopic Dermatitis; Inflammatory Skin Disease

Keywords

atopic dermatitis; wet wrap therapy; Enhanced External Counter-pulsation

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 7

Secondary Outcomes (4)

• achieve EASI 25%/ 50%/ 75% reduction on Day 7

  Day 7

• second week of treatment and achieve EASI 25%/ 50%/ 75% reduction on Day 14

  Day 14

• at least 2 points decrease of itch score/sleep score decrease from Baseline visit

  Day 7 and or Day 14

• least 2-point vIGA/ PGA decrease from baseline

  Day 14

Study Arms (2)

wet wrap therapy (WWT)

ACTIVE COMPARATOR

WWT with mometasone propionate ointment: paraffin soft white 1: 10: once daily (45 minutes ± 15 minutes) x 3 times ±1 time (day 1, day 3, day 5 or any 3 days over 7days, subject to patient self-assessment). For those who do not achieve EASI50 (50% reduction of baseline EASI) or EASI\<10 on Day 7, they will be asked to enroll to another arm (EECP arm), and have a follow-up visit on Day 14 and 4 weeks post last treatment.

Procedure: wet wrap therapy; Device: External compression counter-pulsation (EECP)

EECP therapy

ACTIVE COMPARATOR

EECP therapy once daily x 3 times ±1: Day 1, Day 3, Day 5 (or any 3 days over 7 days). For those who do not achieve EASI50 or EASI total score \< 10 on day 7,(or BSA\>5%) they will be asked to continue for one more cycle (i.e. 3 more EECP sessions over the next 7 days), and will be followed up on Day 14 and at week 4 post-treatment.

Device: External compression counter-pulsation (EECP)

Interventions

wet wrap therapy PROCEDURE

Steps 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

wet wrap therapy (WWT)

External compression counter-pulsation (EECP) DEVICE

External 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; wet wrap therapy (WWT)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Patients who have uncontrolled hypertension, ischemic heart disease or any uncontrolled medical illness
• Patients who have metallic implants or previous fracture of lower limbs, history of deep vein thrombosis or lower limb varicosity (such as varicose vein), untreated malignancy
• Patients who cannot tolerate pressure-cuffing, placing in a horizontal position without arching the back or non-compliance to treatment
• Patients who are taking anticoagulants/ antiplatelet or having bleeding tendency
• Patients who are having undergone recent major surgery
• Patients who have a history of phlebitis with acute thrombotic risk
• Patient who are suffering from an acute disease during the screening period

Sponsors & Collaborators

• The University of Hong Kong: lead

MeSH Terms

Conditions

Dermatitis, Atopic; Dermatitis

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Judy Sham, MCoun

CONTACT

852 2255 5885; js83213@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 7, 2024
• Study Start: July 3, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share