Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2025-12-25 @ 4:01 AM
NCT ID:
NCT06448702
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.
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.
Study:
NCT06448702
Study Brief:
Protocol Section:
NCT06448702