Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06448702
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-03
Brief Title:
Evaluation of Efficacy and Safety of Enhanced External Counter-pulsation on Patients With Atopic Dermatitis and Inflammatory Skin Disease Requiring Wet Wrap Therapy
Sponsor:
The University of Hong Kong
Organization:
The University of Hong Kong
Study Overview
Official Title:
Evaluation of Efficacy and Safety of Enhanced External Counter-pulsation on Patients With Atopic Dermatitis and Inflammatory Skin Disease Requiring Wet Wrap Therapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
Patients with atopic dermatitis AD and erythematous skin disease are often treated with topical treatment containing corticosteroids1 -4 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 insufficiency3 4 Other topical and systemic treatment has been suggested to control atopic dermatitis and other inflammatory skin disorders such as calcineurin inhibitors phototherapy and immunosuppressants4 Patients may need to use in repeated courses according to the skin condition and may experience flare if treatment is discontinued and they have to continue with potential side-effects such as organ impairment and immunocompromised state secondary to systemic immunosuppressants In our practice wet wrap therapy WWT is one of the treatment options for patients with moderate-to-severe AD and some other erythematous inflammatory skin disease and WWT has a relatively fast onset in disease -control especially during a flare New biologics or small molecule inhibitors such as anti-Interleukin 4 or 13 and Januse kinase JAK inhibitor are new treatment modality but the cost is high and may not be affordable to all patients1 5 The fear of potential side effects of local systemic treatment may result in poor compliance and prompting patients to explore alternative therapies Therefore a long-term safe and affordable treatment modality is required to fill this therapeutic gap5
Enhanced external counter-pulsation EECP therapy is a non-invasive method to improve perfusion of vital organs and has been proved to reduce hypercholesterolemia-induced endothelial damage6 It operates by applying ECG-triggered pressure to the lower extremities during diastole by means of air-filled cuffs thus augmenting diastolic blood flow and reducing systolic afterload These in turns increases blood flow to the heart brain and kidneys It has been proved to be effective in increasing the sheer stress of blood vessel and decreasing risk of hypercholesterolemia-induced atherosclerosis by increasing the nitrite oxidase level in blood circulation which has antiatherogenic antithrombotic and anti-inflammatory effects6 In human subjects EECP has also been proved to be effective in improving blood glucose level in patients with diabetes mellitus7 8 It also helped to increase cerebral blood circulation in patients with ischemic stroke and improved neurological recovery9
However there is no pervious study of EECP in patients with atopic dermatitis and erythematous inflammatory skin diseases There are various studies showing that vascular inflammation in moderate -to -severe AD patients is associated with enhanced Th2 response10-12 In addition morphology of blood vessels was abnormal in patients with AD11 and AD patients has higher risks of cardiovascular comorbidities due to the chronic skin inflammation12-13 Therefore using EECP may be an effective adjunct therapy to AD patients to improve circulation and reduce the inflammation
Enhanced external counter-pulsation EECP therapy is a non-invasive method to improve perfusion of vital organs and has been proved to reduce hypercholesterolemia-induced endothelial damage6 It operates by applying ECG-triggered pressure to the lower extremities during diastole by means of air-filled cuffs thus augmenting diastolic blood flow and reducing systolic afterload These in turns increases blood flow to the heart brain and kidneys It has been proved to be effective in increasing the sheer stress of blood vessel and decreasing risk of hypercholesterolemia-induced atherosclerosis by increasing the nitrite oxidase level in blood circulation which has antiatherogenic antithrombotic and anti-inflammatory effects6 In human subjects EECP has also been proved to be effective in improving blood glucose level in patients with diabetes mellitus7 8 It also helped to increase cerebral blood circulation in patients with ischemic stroke and improved neurological recovery9
However there is no pervious study of EECP in patients with atopic dermatitis and erythematous inflammatory skin diseases There are various studies showing that vascular inflammation in moderate -to -severe AD patients is associated with enhanced Th2 response10-12 In addition morphology of blood vessels was abnormal in patients with AD11 and AD patients has higher risks of cardiovascular comorbidities due to the chronic skin inflammation12-13 Therefore using EECP may be an effective adjunct therapy to AD patients to improve circulation and reduce the inflammation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None