Infections

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Warts

Communicable Diseases

Papillomavirus Infections

Virus Diseases

DNA Virus Infections

Skin Diseases

Skin Diseases, Viral

Tumor Virus Infections

Skin Diseases, Infectious

Treated wart with CellFX device intervention

Control wart for each enrolled subject without intervention

The CellFX System utilizes non-thermal, localized delivery of a timed series of low energy, nanosecond electrical pulses that can trigger regulated cell death.

CellFX Device

Richard Nuccitelli, PhD

This prospective, non-randomized, multicenter pivotal study is designed to evaluate the safety and effectiveness of the CellFX System in patients with cutaneous non-genital warts on all areas of the body, excluding the face.

The study will enroll healthy adult subjects with a minimum of two cutaneous non-genital warts, excluding the face, with each wart lesion not exceeding 10 x 10mm. One of the warts for each subject will be untreated and will serve as the subject's internal control. Macrophotography of all study warts will be captured along with Investigator assessments using the Wart Measurement Scale (WMS) and lesion measurements for wart reduction. All subjects will be followed at 7, 30, 60, 90 and 120-days post-initial CellFX treatment. All wart lesions are eligible for re-treatment up to 3 times over the course of the study. Adverse events will be documented.

CellFX System for the Treatment of Cutaneous Non-Genital Warts

A Prospective, Non-Randomized, Multicenter Pivotal Study of Nano-Pulse Stimulation™ (NPS™) Treatment of Cutaneous Non-Genital Warts

Percentage of Verrucae with Clearance (91-100% reduction)

Satisfaction with reduction in verrucae size or clearance of verrucae measured using the following scale; 5 (Satisfied), 4 (Mostly Satisfied), 3 (Partially Satisfied), 2 (Dissatisfied), 1 (Highly Dissatisfied)

Pulse Biosciences, Inc.

CellFX device using pre-defined energy protocols

CellFX Device: The CellFX System utilizes non-thermal, localized delivery of a timed series of low energy, nanosecond electrical pulses that can trigger regulated cell death.

CellFX Treated Wart Lesion

CellFX Treated Verrucae

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Class I

Class II

Class III

Class IV

The Fitzpatrick skin phototypes (FSP) were developed in Boston in 1975 for use with phototherapy. The scale's original purpose was to help determine a patient's risk of burning or tanning when exposed to UV light. The current scale classifies skin from types I to VI. Type I refers to skin that always burns, while type VI refers to skin that never burns. In general, a lower FSP means a person's skin burns more easily than it tans. A higher FSP means that a person's skin does not burn easily.

Fitzpatrick Skin Type

Treated

Control

Not treated

Verrucae Disposition

Common

Plantar

Flat

Wart Subtype

Hand

Foot

Knee

Ankle

Elbow

Wrist

Torso

Anatomic Location

Cryotherapy

Over the Counter Medical Treatment

Laser Treatment

Over the Counter and Laser Treatment

Electrocautery

Cantharone and Cryotherapy

Investigational Product

Aldara and Cryotherapy

Laser Treatment and Cryotherapy

Yeast Injection

History of Prior Verrucae Treatment

Subjects diagnosed with cutaneous warts, including common, flat and plantar subgroups

William A. Knape

Warts Treated With CellFX (Common, Flat, and Plantar)

Percent of verrucae clearance observed at 60-days post-last treatment. Reduction in verrucae size and/or clearance not assessed in the "Non-treated Control" Arm/Group or similar.

Percentage of Verrucae Cleared

All Treated Verrucae observed at 60-days post-last CellFX treatment

Subject Satisfaction

CellFX Treated Warts

Non-treated wart arm, one study wart per enrolled subject.

Non-Treated Controls

Overall Study

CellFX device using pre-defined energy protocols

Cryosurgery will be standardized across all investigational sites. Investigators will perform the Cryosurgical procedure using the Brymill Cry-Ac B700 Liquid Nitrogen Sprayer.

CellFX System Device

Cryosurgery will be standardized across all investigational sites using the Brymill Cry-Ac spray canister with standard cryoprobe.

Cryosurgery Liquid Nitrogen Sprayer

This prospective, multicenter, single-blinded, randomized comparison study is designed to compare the safety and effectiveness of the CellFX System to Cryosurgery for the clearance of cutaneous non-genital common warts on all areas of the body excluding the scalp, nose, within the orbital region of the face, plantar or periungual area in healthy adult subjects.

The study will enroll healthy adult subjects with a minimum of two cutaneous non-genital warts, excluding the face, with each wart lesion not exceeding 10 x 10mm. Macrophotography of all study warts will be captured along with a blinded site Investigator to characterize wart healing, wart clearance and wart reduction. All subjects will be followed at 7, 30, 60, and 90-days following the last CellFX or Cryosurgical Procedure. All wart lesions are eligible for up to a total of 3 treatments over the course of the study. Adverse events will be documented.

Each subject will be evaluated by the blinded site investigator conducting assessment of outcomes at 7, 30, 60, and 90-days following CellFX and Cryosurgical treatments.

CellFX Comparison to Cryosurgery in Cutaneous Non-Genital Common Warts

A Multicenter, Prospective, Randomized, Comparison IDE Study Between the Pulse Biosciences CellFX System and Cryosurgery for the Treatment of Cutaneous Non-Genital Common Warts

The primary effectiveness endpoint is the percentage of warts resolved or cleared as assessed "live" by the blinded site investigator at 30 days after the last treatment with CellFX or Cryosurgical Procedure.

The safety endpoint is the percentage of warts with skin textural changes where the wart was originally treated and showed textual changes of the surrounding skin where the wart was treated and included; scabbing, swelling, crusting, blister, or ulceration when assessed by the blinded site investigator.

The skin change safety event is defined as the presence of hyperpigmentation, hypopigmentation, or scarring as assessed by the blinded site investigator.

CellFX device using pre-defined energy protocols

CellFX System Device: The CellFX System utilizes non-thermal, localized delivery of a timed series of low energy, nanosecond electrical pulses that can trigger regulated cell death.

CellFX Procedure

Cryosurgery will be standardized across all investigational sites. Investigators will perform the Cryosurgical procedure using the Brymill Cry-Ac B700 Liquid Nitrogen Sprayer.

Cryosurgery Liquid Nitrogen Sprayer: Cryosurgery will be standardized across all investigational sites using the Brymill Cry-Ac spray canister with standard cryoprobe.

Cryosurgical Procedure

Total

Ethnicity (NIH/OMB)

Total number of enrolled warts per treatment

William A. Knape, VP Clinical, Regulatory, and Quality Affairs

The population consisted of participants with treated warts and evaluated at 30-days following the last CellFX or Cryosurgical Procedure up to a maximum of 3 months.

Percentage of Warts Resolved

The population consisted of participants with treated warts and evaluated for skin textural changes at 30-days following the last CellFX or Cryosurgical Procedure up to a maximum of 3 months.

Percentage of Warts Treated With Skin Textural Changes

The population consisted of participants with treated warts and evaluated at 90-days following the last CellFX or Cryosurgical Procedure up to a maximum of 6 months.

Presence of Pigmentary and Scarring Skin Changes

Disease Attributes

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Genital Diseases

Urogenital Diseases

Pharmaceutical Solutions

All Drugs and Chemicals

Cantharidin

Enzyme Inhibitors

Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator.

VP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). Treatment interval of at least 14 days between treatments.

VP-102 Cantharidin topical film forming solution

VP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). Treatment interval of at least 21 days between treatments.

VP-102 Cantharidin, topical film forming solution

Adnan Nasir, MD

Scott Guenthner, MD

This is a Phase 2, open label study (Study number VP-102-105; referred to as COVE-1 \[Cantharidin and Occlusion in Verruca Epithelium\]) to evaluate the efficacy, safety and tolerability of VP-102 treatment in subjects with common warts. This study has two Cohorts.

The first Cohort (Cohort 1) utilizes a treatment interval of at least 14 days between treatments with longer treatment intervals being allowed depending on a specific patient's clinical response.Twenty Subjects (2 years and older) are targeted completing End of Study (EOS) visit in Cohort 1.

The second Cohort (Cohort 2) utilizes a treatment interval of 21 days between treatments. Paring of lesions is allowed. Approximately 35 subjects (12 years and older) will be enrolled in Cohort 2. Up to 4 sites will participate in the study.

This study has 2 cohorts. Cohort 1 of the study enrolled 21 subjects and has completed all subject related study activities. Analysis is to be conducted at Day 84. Cohort 2 will utilize 4 sites with an enrollment of approximately 35 subjects. The primary analysis will be conducted at Day 84 with an additional period of follow up out to Day 147.

Cantharidin and Occlusion in Verruca Epithelium

A Phase 2, Open Label Study to Evaluate the Efficacy, Safety and Tolerability of VP-102 in Subjects With Common Warts (Verruca Vulgaris)

Cohort 1: Percent change from baseline in the number of treatable warts (Baseline and new) from Baseline at Visit 2, Visit 3, Visit 4 and over the duration of the study.

Cohort 1: Change from baseline in the number of treatable warts (baseline and new) at Visit 2, Visit 3, Visit 4 and the EOS Visit.

Cohort 1: Proportion of subjects exhibiting ≥ 50% clearance of all treatable warts (baseline and new) at the EOS visit as compared to baseline.

Cohort 1-Proportion of subjects who respond to treatment defined by a ≥ 50% reduction in total wart area at EOS compared to baseline.

Cohort 1-Proportion of subjects exhibiting reduction of at least 1 treatable wart from baseline at Visit 2, Visit 3, Visit 4 and at the EOS Visit (Day 84).

Cohort 2: Intent to Treat population Cohort 2-Percent reduction of all treatable warts (baseline and new) from baseline at Visit 2, Visit 3, Visit 4 and over duration of the study.

Cohort 2: Change from baseline in the number of treatable warts (baseline and new) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4 and the EOT Visit (Day 84).

Cohort 2: Proportion of subjects exhibiting ≥ 50 % clearance of all treatable warts (baseline and new) at the EOT Visit (Day 84) as compared to baseline.

Cohort 2: Proportion of subjects who respond to treatment defined by a ≥ 50% reduction in total wart area at EOT compared to baseline.

Cohort 2: Proportion of subjects exhibiting reduction of at least 1 treatable wart from baseline at Visit 2, Visit 3, Visit 4 and at the EOT Visit (Day 84).

Cohort 2: Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at follow-up visits on Day 105, Day 126 and Day 147.

Cohort 2: Percent reduction of all treatable warts (baseline and new) from baseline at follow-up visits on Day 105, Day 126 and Day 147.

Cohort 2: Change from baseline in the number of treatable warts (baseline and new) at follow-up visits on Day 105, Day 126 and Day 147.

Cohort 1: Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at the EOS Visit (Day 84).

Cohort 2: Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at the EOT Visit (Day 84).

Cohort 1: Change from baseline in the number of treatable warts (baseline and new) at the EOS Visit (Day 84).

Cohort 1: Assessing the percent change from Baseline in the number of treatable warts (Baseline and new) at the EOT visit (Day 84).

Cohort 1: Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at Visit 2, Visit 3, Visit 4 and over the duration of the study.

Cohort 2: Change from baseline in the number of treatable warts (baseline and new) at the EOT Visit Day 84).

Cohort 2: Change from baseline in the percent of treatable warts (baseline and new) at the EOT Visit (Day 84).

Cohort 2: Proportion of subjects exhibiting complete clearance of all treatable warts, (baseline and new), at Visit 2, Visit 3, Visit 4 and over the duration of the study.

Instat Consulting, Inc.

Paidion Research, Inc.

BioClinica, Inc.

ALMAC Clinical Services

Verrica Pharmaceuticals Inc.

Treatment Emergent Adverse Events (TEAEs) are defined as those AEx that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE was considered treatment emergent. Local skin reactions to treatment were recorded as AEs.

Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. utilized a treatment interval of at least 14 days between treatments with longer treatment intervals being allowed depending on a specific patient's clinical response. No paring of lesions was allowed. Subjects were 2 years and older.

Cohort 1

Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. Utilized a treatment interval of 21 days between treatments. Paring of lesions was allowed. Subjects were 12 years and older.

Cohort 2

Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator.

Utilized a treatment interval of at least 14 days between treatments with longer treatment intervals being allowed depending on a specific patient's clinical response. No paring of lesions was allowed.

VP-102 Cantharidin topical film forming solution: VP-102 Cantharidin topical film forming solution. Treatment interval of at least 14 days between treatments.

VP-102 Applicator: The applicator is used to apply the Study drug.The product is a combination therapy which includes the drug VP-102 and the applicator which is the device.

VP-102 - Cohort 1

Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator.

Utilized a treatment interval of at least 21 days between treatments with longer treatment intervals being allowed depending on a specific patient's clinical response. Paring of lesions was allowed.

VP-102 Cantharidin topical film forming solution: VP-102 Cantharidin topical film forming solution. Treatment interval of at least 21days between treatments.

VP-102 Applicator: The applicator is used to apply the Study drug.The product is a combination therapy which includes the drug VP-102 and the applicator which is the device.

VP-102 - Cohort 2

Age, Categorical

Baseline wart count

Study participants enrolled into Cohort 1 were not included in Cohort 2. New subjects were enrolled into Cohort 2.

Susan Cutler, VP, Medical Affairs

Cohort 1: Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at the EOS Visit (Day 84)

Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator.

Utilized a treatment interval of 21 days between treatments. Paring of lesions was allowed.

VP-102 Cantharidin, topical film forming solution: VP-102 Cantharidin topical film forming solution. Treatment interval of at least 21 days between treatments.

VP-102 Applicator: The applicator is used to apply the Study drug.The product is a combination therapy which includes the drug VP-102 and the applicator which is the device.

Cohort 2: Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at the EOT Visit (Day 84)

Baseline

End of Treatment Visit

Cohort 1: Change From Baseline in the Number of Treatable Warts (Baseline and New) at the EOS Visit (Day 84)

Cohort 1: Percent Change From Baseline in the Number of Treatable Warts (Baseline and New) at the EOT Visit (Day 84).

Complete Clearance Reported at any Visit?

Complete Clearance Reported at Day 14

Complete Clearance Reported at Day 28

Complete Clearance Reported at Day 42

Complete Clearance Reported at Day 84 (EOS)

Cohort 1: Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at Visit 2, Visit 3, Visit 4 and Over the Duration of the Study

Cohort 2: Change From Baseline in the Number of Treatable Warts (Baseline and New) at the EOT Visit Day 84)

Cohort 2: Change From Baseline in the Percent of Treatable Warts (Baseline and New) at the EOT Visit (Day 84)

Complete Clearance Reported at Day 21 (Treatment Visit 2)

Complete Clearance Reported at Day 42 (Treatment Visit 3)

Complete Clearance Reported at Day 63 (Treatment Visit 4)

Complete Clearance Reported at Day 84 (EOT)

Complete Clearance Reported at Day 105

Complete Clearance Reported at Day 126

Complete Clearance Reported at Day 147

Cohort 2: Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts, (Baseline and New), at Visit 2, Visit 3, Visit 4 and Over the Duration of the Study

Treatment Visit 2 Day 14

Treatment Visit 3 Day 28

Treatment Visit 4 Day 42

EOS Day 84

Cohort 1:Percent Reduction of All Treatable Warts (Baseline and New) From Baseline at Visit 2, Visit 3, Visit 4 and Over the Duration of the Study.

Treatment Visit 2

Treatment Visit 3

Treatment Visit 4

End of Study

Cohort 1: Change From Baseline in the Number of Treatable Warts (Baseline and New) at Visit 2, Visit 3, Visit 4 and the EOS Visit

Cohort 1: Proportion of Subjects Exhibiting ≥ 50% Clearance of All Treatable Warts (Baseline and New) at the EOS Visit as Compared to Baseline

Cohort 1-Proportion of Subjects Who Respond to Treatment Defined by a ≥ 50% Reduction in Total Wart Area at EOS Compared to Baseline

Reduction of >= 1 Wart from Baseline at any visit?

Cohort 1-Proportion of Subjects Exhibiting Reduction of at Least 1 Treatable Wart From Baseline at Visit 2, Visit 3, Visit 4 and at the EOS Visit (Day 84)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
CellFX System for the Treatment of Cutaneous Non-Genital Warts	NCT04554394	Warts Warts Hand Verruca	CellFX Device	21 Years - 80 Years	Pulse Biosciences, Inc.
CellFX Comparison to Cryosurgery in Cutaneous Non-Genital Common Warts	NCT04738734	Warts Warts Hand Verruca	CellFX System D... Cryosurgery Liq...	22 Years - 80 Years	Pulse Biosciences, Inc.
Cantharidin and Occlusion in Verruca Epithelium	NCT03487549	Common Wart Warts Hand Warts Papillomavirus ... DNA Virus Infec... Skin Diseases, ... Skin Diseases, ... Skin Diseases Virus Diseases Tumor Virus Inf... Verruca Vulgari... Verruca	VP-102 Canthari... VP-102 Canthari...	2 Years -	Verrica Pharmaceuticals Inc.
CellFX System for the Treatment of Cutaneous Non-Genital Warts	NCT04554394	Warts Warts Hand Verruca	CellFX Device	21 Years - 80 Years	Pulse Biosciences, Inc.
CellFX Comparison to Cryosurgery in Cutaneous Non-Genital Common Warts	NCT04738734	Warts Warts Hand Verruca	CellFX System D... Cryosurgery Liq...	22 Years - 80 Years	Pulse Biosciences, Inc.
Cantharidin and Occlusion in Verruca Epithelium	NCT03487549	Common Wart Warts Hand Warts Papillomavirus ... DNA Virus Infec... Skin Diseases, ... Skin Diseases, ... Skin Diseases Virus Diseases Tumor Virus Inf... Verruca Vulgari... Verruca	VP-102 Canthari... VP-102 Canthari...	2 Years -	Verrica Pharmaceuticals Inc.

Spots Global Cancer Trial Database for warts hand

Every month we try and update this database with for warts hand cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for warts hand

Every month we try and update this database with for warts hand cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for warts hand cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.