Author: Super Administrator

Synopsis

Localized, superficial microwave energy (ME) appears to have promise as a novel, rapid, and tolerated non-invasive approach to induce localized hyperthermic conditions for treating cutaneous non-melanoma skin cancers (NMSCs). Squamous cell carcinoma in situ (SCCis) is a very common NMSC appearing on sun exposed skin including the face. Standard treatments include excision or electrodessication and curettage, but other minimally invasive treatments are desirable, especially for areas with aesthetic importance, like the face, or regions that are slow to heal, such as the lower legs. Hyperthermia, a non-invasive treatment that raises tissue temperature above 43 degrees Celsius, has a long history in treating various cancers. Traditional hyperthermic treatments require warming large areas of tissue, but new technology now permits focused application of microwave energy (ME) to generate precisely targeted hyperthermic conditions in treated tissues. Literature suggests that localized hyperthermia increases tumor cell immunogenicity by activating stress response pathways in proliferative keratinocytes, promoting lesion clearance through innate and adaptive immune responses as well as apoptosis. Currently, both actinic keratoses (AKs) and human papillomavirus (HPV)-induced warts have been successfully treated with site-specific ME-induced hyperthermia. Given the higher incidence of SCCis in individuals with actinic damage and the evidence that ME can clear AK and hypertrophic AK (early stages in the squamous neoplasia continuum), increasing tumor immunogenicity via localized ME-induced hyperthermia may explain the observed clearance of cutaneous SCC (cSCC) lesions in the treated patients presented here. This feasibility work represents the first exploratory step in determining if ME-induced hyperthermia can serve as a novel, non-invasive treatment for NMSCs.

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Mark S. Nestor, Angelica Marrero-Perez, Aysham Chaudry and Robert Vanaria, Presented at the Fall Clinical Dermatology Conference 2024

ABSTRACT

Introduction:  Treating hidradenitis suppurativa (HS) is challenging due to its chronic, recurring nature and resistance to conventional therapies like antibiotics, anti-inflammatories, and surgery. Even with new biological treatments, there are challenges with injection site reactions. The associated pain, drainage, malodor, and scarring also significantly impact patients’ mental well-being, underscoring the need for novel treatments. Four cases presented here suggest that microwave energy (ME) therapy can reduce pain, erythema and inflammation in HS lesions and even assist to resolve moderate and smaller lesions. Precise and brief surface-based applications of microwave energy to HS lesions from an FDA-cleared  microwave device intended for the coagulation of soft tissue were used to generate localized hyperthermic conditions in HS and pre-HS lesions. The rapid heating of the tissues led to subsequent clearance of moderate and small HS lesions. This was accompanied with a reduction in inflammation, draining and pain associated with these HS cases. While the outcomes are promising, the exact mechanism of action needs further investigation. These cases strongly support further research and demonstrate that ME holds promise as a novel, non-invasive treatment modality for the management of HS.

Procedure:  A total of 25 HS lesions from five patients were treated with ME energy. Five repetitive 2-second pulses of 3 to 4W of ME operating at 8GHz were applied to the full area of these lesions. Three to four treatment sessions were given ranging from 7 to 14 days apart.  Two patients received ME as a monotherapy, whereas the others began regimens of isotretinoin, adalimumab, or secukinumab at the same time as the first ME treatment.

Results:  These five patient cases demonstrate how ME treatments can lead to a rapid reduction in reported pain and erythema as well as clinical-assessed clearance of several early and moderate state HS lesions. Two of these patients only received ME as a monotherapy. However, based on clinical experience, even patients typically on medications will not typically show improvements within 7-14 days, suggesting that ME was having a rapid impact to manage pain and inflammation associated with HS lesions and in some cases assisting to resolve these lesions entirely.

Conclusions:  These cases report the first step in clinical feasibility and safety of microwave energy and shows promise as a novel modality for the management of HS. Although still in the early days of feasibility work, this non-invasive, fast, well-tolerated and simple treatment of microwave energy shows promise as a novel modality for the management of HS.

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Nicole Bielecki PA-C and Aaron Hoover MD, Presented at the Fall Clinical Dermatology Conference 2024

Background: Onychomycosis is a common fungal nail disease with a prevalence rate up to 14% in North America and 24% in Europe. The current treatment paradigm is limited by a high risk of disease recurrence, safety concerns for oral agents, and a low likelihood of patients achieving both clinical improvement and mycological cure. Recent advances in device‐based treatments have allowed for the direct targeting of the infection site that bypasses drug resistance mechanisms while minimizing systemic side‐effects. The Swift® System is a microwave device that has demonstrated therapeutic potential in treating skin (e.g. verrucae vulgaris, actinic keratosis) and nail infections.

Methods: We report the protocol of an open‐label, randomized, pilot study that will be conducted at a single Canadian center. Our primary objective is to evaluate the safety and efficacy of microwave treatment (Swift® System, Emblation Ltd, Scotland, U.K.), administered at three different dosing regimens, in 45 patients with mild‐to‐moderate distal subungual onychomycosis. Our secondary objective is to identify an optimal dosing regimen, if any, to better inform the conduct of a future pivotal trial. Patients will be randomized (1:1:1) to undergo either 9 treatment sessions (5 weekly sessions plus 4 monthly sessions), 7 treatment sessions (3 sessions every 2 weeks plus 4 monthly sessions), or 12 treatment sessions every 2 weeks. At each session microwave energy will be applied in 3‐s intervals at 7– 9 Watts, repeated up to 5 times at each treatment position on the nail. Overlapping treatment positions are used to ensure sufficient coverage of the infected area. Patients will be enrolled in the trial over a 12‐month period. Efficacy will be evaluated based on visual improvement and mycology testing results. Adverse events will be recorded throughout the entire study period.

Discussion: This study will be the first to report on the safety and efficacy of microwave treatment in onychomycosis patients in a trial setting; recruitment is ongoing.

Trial registration: ClinicalTrials.gov, NCT05674747.

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Aditya K. Gupta, Elizabeth A. Cooper, Tong Wang

Patients with diabetes who develop ulcers are ultimately often at risk of lower extremity surgical amputation if the wound cannot be managed and healed.

In the UK in 2023, more than 4.3 million people were reported to live with diabetes, although this figure is likely under-representative as an estimated 850,000 people remain undiagnosed. Worldwide, about 463 million people are reportedly diagnosed with diabetes, equating to almost 10% of the population based on a 2019 valuation.

This case report describes a patient who faced amputation due to the development of bilateral ulcerated hyperkeratotic verruca on the plantar surface. Over the course of nearly 5 years, traditional management strategies failed to resolve the lesions however treatment of the verrucae with microwave energy resulted in full resolution and complete healing of the ulcers on both feet. These outcomes significantly changed the patient’s life and may offer a therapeutic approach for patients with similar, stubborn HPV infected hyperkeratosis.

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Tracy Davies, Colin Long

Plantar keratoma are common hyperkeratinized, deep-seated lesions, often located on weightbearing areas of the foot. Such lesions are frequently associated with pain and disability. Intractable plantar keratomata (IPK) are highly recurrent and, in most patients, require regular, palliative treatment visits with a significant impact on patient time, cost, and quality of life.

This article is a retrospective chart review of 9 patients (with a total of 21 lesions) who underwent a minimum of two treatments using microwave therapy to their IPK. Pain levels were assessed at each of their treatments using a 10-point scale and patients were invited for review for follow-up in the following year. A total of seven patients undertook four treatments and were included in the final analysis.

Mean baseline pain scores significantly dropped with each subsequent treatment, equating to a 90.4% mean reduction in pain between the first and fourth visits, with 71.4% of patients reporting a zero-pain rating at their final treatment visit. Concluding the use of microwave therapy has been shown to be effective in producing significant and prolonged pain reduction in a cohort of patients with painful IPK.

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Ivan R. Bristow, Raphael Lilker

“The use of microwaves in the treatment of long-standing and particularly stubborn warts represents a valuable addition to the therapeutic toolkit. The good response rates not only create satisfied patients, but also become a positive experience for the therapist.”

Since the beginning of this year, we have also been able to treat warts using microwaves. We are happy to be able to offer our patients who do not respond adequately to conventional therapy another treatment option.

Keypoints

• Immunomodulatory hyperthermia procedure, which is particularly recommended for therapy-resistant warts.
• Particularly suitable for children, active adults and patients with limited mobility as it is less complex to use and no soaking or scraping is required.
• Although it can be combined with other treatments, treatment on softened calluses is more painful and is not recommended. After treatment, walking without pain is often possible quickly.
• The short duration of a session makes it easier to integrate into everyday practice without additional equipment and can be delegated.

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“Die Anwendung der Mikrowelle in der Behandlung von langbestehenden und besonders hartnäckigen Warzen stellt eine wertvolle Erweiterung des therapeutischen Instrumentariums dar. Die guten Ansprechraten schaffen nicht nur zufriedene Patienten, sondern werden auch zu einer positiven Erfahrung für den Therapeuten.”

Seit Anfang dieses Jahres besteht auch bei uns die Möglichkeit, die Warzen mittels Mikrowelle behandeln zu lassen. Wir sind froh, unseren Patienten, welche auf die konventionelle Therapie nur unzureichend ansprechen,eine weitere Therapiemöglichkeit anbieten zu können.

Keypoints

• Immunmodulatorisches Hyperthermie-Verfahren, das besonders bei therapieresistenten Verrucae empfohlen wird.
• Besonders geeignet für Kinder, aktive Erwachsene und bewegungseingeschränkte Patienten, da weniger aufwendig in der Anwendung und kein Einweichen oder Abschaben erforderlich.
• Obwohl grundsätzlich mit anderen Mitteln kombinierbar, ist die Behandlung auf aufgeweichter Hornhaut schmerzhafter und nicht empfohlen. Nach der Behandlung ist ein schmerzfreies Gehen oft schnell möglich.
• Die kurze Dauer einer Sitzung erleichtert die Integration in den Praxisalltag ohne zusätzliches Equipment und kann delegiert werden.

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Helena Odermatt, Bettina Rümmelein