Dataset Information

Safety and Efficacy of Nano-Pulse Stimulation Treatment of Non-Genital, Cutaneous Warts (Verrucae).

ABSTRACT:

Background and objectives

This study describes the effects of nano-pulse stimulation (NPS) technology on the common verruca with the objectives of demonstrating efficacy and safety. NPS technology applies nanosecond pulses of non-thermal electrical energy to induce highly localized regulated cell death in the cellular structures of the targeted zone with negligible effects on surrounding non-cellular structures. Previous clinical studies applying NPS to common, benign skin lesions have demonstrated safety and efficacy in clearing seborrheic keratoses and sebaceous hyperplasia.

Study design/materials and methods

Sixty-two subjects were enrolled at a total of five sites. One hundred and ninety-five study verrucae up to 10 mm wide were treated with NPS delivered by a console-based handheld applicator (CellFX® System; Pulse Biosciences) and follow-ups occurred every 30 days with the option to retreat at 30, 60, and 90 days. There were 62 untreated controls and 46% of the treated verrucae were recalcitrant.

Results

Overall, 75.3% (70/93) of the common verrucae, 72.7% (8/11) of the flat verrucae, and 43.8% (14/32) of the plantar verrucae treated with NPS were completely clear by 60 days following the last treatment and did not recur within the 120-day observation period. The majority (54%) of verrucae cleared with a single NPS procedure. The most common treatment site reactions were erythema (50.5%) and eschar formation (23.4%) on Day 30 and on Day 120 mild erythema was present in 14% of the cases and hyperpigmentation in 18.5%. No serious adverse events were reported. A particle counter was used during 11 NPS procedures on verrucae and no significant plume generation was detected during these procedures.

Conclusions

SUBMITTER: Nuccitelli R

PROVIDER: S-EPMC9291480 | biostudies-literature | 2021 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Safety and Efficacy of Nano-Pulse Stimulation Treatment of Non-Genital, Cutaneous Warts (Verrucae).

Nuccitelli Richard R LaTowsky Brenda M BM Lain Edward E Munavalli Girish G Loss Lesley L Ross E Victor EV Jauregui Lauren L Knape William A WA

Lasers in surgery and medicine 20210519 10

<h4>Background and objectives</h4>This study describes the effects of nano-pulse stimulation (NPS) technology on the common verruca with the objectives of demonstrating efficacy and safety. NPS technology applies nanosecond pulses of non-thermal electrical energy to induce highly localized regulated cell death in the cellular structures of the targeted zone with negligible effects on surrounding non-cellular structures. Previous clinical studies applying NPS to common, benign skin lesions have d ...[more]

PMID: 34008877

Similar Datasets

Project description:ObjectiveTo review published randomised controlled trials to assess the benefit and harm of imiquimod in the treatment of external genital warts.Data sourcesMEDLINE (1966 - December 2000), Cochrane Library (Issue 3, 2000) and PubMed (December 15, 2000), review articles and reference lists.Review methodsIncluded studies had to be randomised trials of imiquimod, to be full published papers, and to have a comparison group. Quality of trial reporting was assessed. Relative benefit and number needed to treat were calculated for the main outcomes of wart clearance at the end of therapy, of at least 50% reduction in wart area, and of complete clearance at the end of treatment and no recurrence of warts during a follow-up period, as well as for adverse effect withdrawal or lack of efficacy withdrawal.ResultsThere were six trials, all with quality scores of 3 (out of 5) or greater. In five trials with HIV-negative patients complete clearance of warts at the end of treatment occurred in 51% of patients treated with imiquimod 2% or 5% cream and 6% of placebo treated patients. The number needed to treat was 2.2 (95% confidence interval 2.0 to 2.6). In four trials at least 50% wart area reduction occurred with 72% of patients treated with imiquimod 5% cream and 20% of placebo treated patients. The number needed to treat was 1.9 (1.7 to 2.2). In three trials complete clearance of warts at the end of treatment plus no recurrence occurred in 37% of patients treated with imiquimod 5% cream and 4% of those treated with placebo. The number needed to treat was 3.0 (2.5 to 3.8). Adverse event withdrawal was rare and no more likely with imiquimod than with placebo. Imiquimod was not effective in one trial in HIV-positive patients.ConclusionThe evidence base for imiquimod in treating genital warts is of high quality and the necessary size from which to draw useful conclusions. Imiquimod is effective in home application, though not in patients with HIV infection with the evidence presently available.

Project description:Background: Substantial declines in genital warts (GW) have been observed in countries with quadrivalent HPV vaccination programmes, with Australia showing the highest reductions due to early commencement and high vaccination coverage. There is a real potential to achieve GW elimination; however, no GW elimination definition exists. Taking Australia as a case study, we aimed to reach expert consensus on a proposed GW elimination definition using a modified Delphi process. Method: We used modelling and epidemiological data to estimate the expected number of new GW cases, from pre-vaccination (baseline) in 2006 to the year 2060 in Australian heterosexuals, men who have sex with men (MSM), and newly arrived international travellers and migrants. We used these data and the literature, to develop a questionnaire containing ten elimination-related items, each with 9-point Likert scales (1-strongly disagree; 9-strongly agree). The survey was completed by 18 experts who participated in a full day face-to-face modified Delphi study, in which individuals and then small groups discussed and scored each item. The process was repeated online for items where consensus (≥70% agreement) was not initially achieved. Median and coefficient of variation (COV) were used to describe the central tendency and variability of responses, respectively. Findings: There was a 95% participation rate in the face-to-face session, and 84% response rate in the final online round. The median item score ranged between 7.0 and 9.0 and the COV was ≤0.30 on all items. Consensus was reached that at ≥80% HPV vaccination coverage, GW will be eliminated as a public health problem in Australia by 2060. During this time period there will be a 95% reduction in population-level incidence compared with baseline, equivalent to <1 GW case per 10,000 population. The reductions will occur most rapidly in Australian heterosexuals, with 73%, 90% and 97% relative reductions by years 2021, 2030 and 2060, respectively. The proportion of new GW cases attributable to importation will increase from 3.6% in 2006 to ~49% in 2060. Interpretation: Our results indicate that the vaccination programme will minimise new GW cases in the Australian population, but importation of cases will continue. This is the first study to define GW elimination at a national level. The framework developed could be used to define GW elimination in other countries, with thresholds particularly valuable for vaccination programme impact evaluation. Funding: LK supported through an Australian Government Research Training Programme Scholarship; unconditional funding from Seqirus to support the Delphi Workshop.

Dataset Information

Safety and Efficacy of Nano-Pulse Stimulation Treatment of Non-Genital, Cutaneous Warts (Verrucae).

Background and objectives

Study design/materials and methods

Results

Conclusions

Publications

Safety and Efficacy of Nano-Pulse Stimulation Treatment of Non-Genital, Cutaneous Warts (Verrucae).

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