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

Placebo for East Indian Sandalwood Oil ointment administered topically twice daily

East Indian Sandalwood Oil ointment, 10% (w/w), applied topically twice daily

East Indian Sandalwood Oil ointment, 20% (w/w), applied topically twice daily

East Indian Sandalwood Oil ointment, 30% (w/w), applied topically twice daily

During the Treatment Period, subjects will apply study medication (10% EISO) to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks.

10% EISO

During the Treatment Period, subjects will apply placebo to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks.

Placebo

During the Treatment Period, subjects will apply study medication (20% EISO) to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks.

20% EISO

During the Treatment Period, subjects will apply study medication (30% EISO) to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks.

30% EISO

Nonclinical studies have shown sandalwood oil to have anti-inflammatory, anti-fungal, antiviral, and anti-bacterial activities. Previous clinical studies have shown East Indian Sandalwood oil to be promising as a treatment for common warts in adults and children.

The primary objective of this study is to evaluate the efficacy and safety of 10%, 20%, and 30% East Indian Sandalwood Oil (EISO) ointment compared with the ointment placebo administered twice daily (bid) for 12 weeks for the treatment of common warts (Verruca vulgaris).

A Trial of a Botanical Drug Containing East Indian Sandalwood Oil (EISO) for Treatment of Common Warts

A Randomized, Double-blind, Multi-center, Placebo-controlled, Dose-ranging, Efficacy and Safety Trial of a New Botanical Drug Product Containing East Indian Sandalwood Oil (EISO) for Treatment of Common Warts (Verruca Vulgaris)

During the Treatment Period, subjects will apply study medication to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks. Clinical evaluations, including wart counts, wart measurements and recording of adverse events and concomitant medications will be performed. Photographs of the treatment area will be taken at all study visits

Partial Resolution is defined as \>/= 75% Reduction of treated wart

ViroXis Corporation

Placebo for East Indian Sandalwood Oil ointment administered topically twice daily

Placebo: During the Treatment Period, subjects will apply placebo to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks.

East Indian Sandalwood Oil ointment, 10% (w/w), applied topically twice daily

10% EISO: During the Treatment Period, subjects will apply study medication (10% EISO) to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks.

East Indian Sandalwood Oil ointment, 20% (w/w), applied topically twice daily

20% EISO: During the Treatment Period, subjects will apply study medication (20% EISO) to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks.

East Indian Sandalwood Oil ointment, 30% (w/w), applied topically twice daily

30% EISO: During the Treatment Period, subjects will apply study medication (30% EISO) to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks.

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Height

Weight

Dr. Paul Castella Ph.D.

FAS population was used for this outcome measure

Complete Resolution of All Treated Warts by or at Week 12

FAS population used for this outcome measure.

Number of Subjects Achieving Partial Resolution of Treated Warts

Overall Study

Pharmaceutical Solutions

All Drugs and Chemicals

Anti-Infective Agents

Central Nervous System Depressants

Hydrogen Peroxide

Ethanol

Anti-Infective Agents, Local

A-101

vehicle

A Phase 3 Study of A-101 Topical Solution Applied Twice a Week in Subjects with Common Warts

A Phase 3 Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study of A-101 Topical Solution Applied Twice a Week in Subjects with Common Warts

Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study

The blinded vehicle solution is packaged to match the active study drug and will be stored under the same conditions.

Study of A-101 Topical Solution for the Treatment of Common Warts

A Phase 3 Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study of A-101 Topical Solution Applied Twice a Week in Subjects With Common Warts

The primary efficacy endpoint is the number of subjects whose identified common warts are determined to be clear on the Physician Wart Assessment (PWA) scale (PWA=0) at Visit 10 (Day 60).

Efficacy will be assessed using the Physician's Wart Assessment Scale (PWA) which is a 4 point scale. A higher amount of warts cleared represents a better outcome.

Number of subjects whose identified common warts are determined to be clear on the Physician Wart Assessment (PWA) scale (PWA=0) at Visit 13 (Day 137).

Efficacy will be assessed using the Physician's Wart Assessment Scale (PWA) which is a 4 point scale. A higher amount of warts cleared represents a better outcome.

Mean Per-Subject Percent of All Warts That Were Clear on the Physician Wart Assessment (PWA) Scale Between Active and Vehicle That Are Clear (PWA=0) at Day 137.

Clearance of all treated warts will be assessed using the Physician Wart Assessment (PWA) scale which is a four point scale. A higher amount of warts cleared represents a better outcome.

Comparison between Active (A-101 45%) and Vehicle of subjects with a single wart at baseline, whose wart is clear (PWA=0) at Day 60.

Clearance of the single wart at baseline will be assessed using the Physician Wart Assessment (PWA) scale which is a four point scale. A higher amount of warts cleared represents a better outcome.

Comparison between Active (A-101 45%) and Vehicle with respect to the median time to achieve onset of clearance (PWA=0) for all treated warts at Day 137.

Clearance of all treated warts will be assessed using the Physician Wart Assessment (PWA) scale which is a four point scale. A higher amount of warts cleared represents a better outcome.

Aclaris Therapeutics, Inc.

An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and that did not necessarily have a causal relationship with the study medication.

Safety summaries by study medication group will include listings by study medication of adverse events incidences within each MedDRA System Organ Class, and changes from pre-application values in vital signs.

Topical solution, hydrogen peroxide 45% A-101: hydrogen peroxide 45% topical solution

Active

Topical solution, isopropyl alcohol and water Vehicle: Vehicle solution containing isopropyl alcohol and water

Vehicle

Age, Categorical

I - Always Burns

II - Burns Easily

III - Burns Moderately

IV - Burns Minimally

V - Rarely Burns

VI - Never Burns

Fitzpatrick Skin Type

Prior Treatment of any Wart Treated

Total Warts Treated

Time Since First Appearance of Most Recent Wart Treated (Days)

Time since First Appearance of Least Recent Wart Treated (Days)

Longest Axis of "Largest" Wart Treated (mm)

Thickness of "Largest" Wart Treated (mm)

Aclaris Clinical Operations

A summary of the wart clearance at Visit 10.

Warts at Baseline - All

Warts at Baseline - 1

Warts at Baseline - 2

Warts at Baseline - 3

Warts at Baseline - >3

Hydrogen Peroxide 45% A-101

Isopropyl Alcohol and Water Vehicle

The study's primary endpoint was to evaluate the amount of patients achieving a clearance of all baseline WARTS. Patients were stratified by the amount of WARTS at Baseline.

The Primary Efficacy Endpoint is the Number of Subjects Whose Identified Common Warts Are Determined to be Clear on the PWA Scale (PWA=0) at Visit 10 (Day 60)

topical solution

A-101: hydrogen peroxide topical solution 45%

topical solution

vehicle: vehicle as a topical solution

The secondary efficacy endpoint is the number of subjects whose identified common warts are determined to be clear on the Physician Wart Assessment (PWA) scale (PWA=0) at Visit 13 (Day 137).

Efficacy will be assessed using the Physician's Wart Assessment Scale (PWA) which is a 4 point scale.

Number of Subjects With Complete Clearance of All Treated Common Warts Between Active and Vehicle on the Physician Wart Assessment (PWA) Scale (PWA=0) at Visit 13 (Day 137)

Clearance of all treated warts will be assessed using the Physician Wart Assessment (PWA) scale which is a four point scale.

Mean Per-Subject Percent of All Warts That Were Clear on the Physician Wart Assessment (PWA) Scale Between Active and Vehicle That Are Clear (PWA=0) at Visit 13 (Day 137)

Number of Subjects With a Single Wart at Baseline Whose Wart Was Clear on the PWA Scale Between Active and Vehicle Group (PWA=0) at Visit 10 (Day 60)

A median was not able to be calculated in the Vehicle group due to an insufficient number of participants with events.

Median Time for Subjects to Achieve Clearance (PWA=0) of All Treated Common Warts

(group A): thirty patients will be treated by application of carbon dioxide laser.

(group B): thirty patients will be treated by cryotherapy application.

Carbon dioxide laser

Cryotherapy

Nagwa Essa, PD

Hanan Ahmed, MD

Viral warts are common skin conditions seen in both children and adults. Human papilloma virus is responsible for verrucae. Cutaneous manifestation of the human papillomavirus, are extremely common particularly on the hands and feet. Warts can induce hard, thickened skin, black pinpoints, pain or tenderness with significant morbidity for the patients.

A range of types of wart have been identified, varying in shape and site affected, as well as the type of human papillomavirus involved.

These include:

* Common wart (Verruca vulgaris).
* Flat wart (Verruca plana).
* Filiform or digitate wart.
* Genital wart (venereal wart, Condyloma acuminatum, Verruca acuminata).
* Mosaic wart.
* Periungual wart.
* Plantar wart (verruca, Verruca plantaris). Despite the presence of several therapeutic options, treatment of warts can present a challenge and they are not uniformly effective. Viral warts often disappear without treatment. In case of pain, discomfort and long duration they can be treated . Treatment options include cryotherapy, electrocautery, salicylic acid, immune therapy, minor surgery or laser surgery.

Common warts have a distinctive appearance and can usually be diagnosed with the unaided eye; however, early growth stages and post-treatment warts are less easily diagnosed. Published dermoscopic features of common warts include frogspawn pattern, mosaic pattern and dotted, linear, globular or coiled vessels. Mosaic pattern consists of relatively flattened, rounded structures of similar size, resembling a jigsaw puzzle. Frogspawn pattern consists of densely packed papillae, each containing red dot or loop, surrounded by a whitish halo. Vascular structures seen dermoscopically in common warts as red or black dotted, linear, globular and coiled vessels. Haemorrhages are possible additional features, with black dots corresponding to thrombosed vessels. Hairpin vessels were usually seen in non-wart lesions.

In this study, we aim to compare two therapeutic modalities, the clinical effectiveness and safety of carbon dioxide laser and cryotherapy in the treatment of viral warts together with dermoscopic evaluation of viral warts before and after treatment.

Carbon Dioxide Laser and Cryotherapy in Treatment of Warts

Comparative Evaluation of Carbon Dioxide Laser and Cryotherapy by Dermoscopy in Treatment of Viral Wart

Assiut University

Principal Investigator

The study will be a single center, open label, non-randomized clinical trial that will provide efficacy data for the treatment of common warts by the Nanopulse system in terms of efficacy and cosmetic outcome with 1 - 4 application (treatment) sessions. All subjects will receive a minimum number of applications per discrete skin wart lesion. Up to 4 warts per subject will be treated with the Nanopulse device. The wart will be debulked to the point of pinpoint bleeding prior to the initial application. The subject will return after 1 week for an evaluation visit and at 4 weeks for a second treatment and 2 additional monthly treatments if warranted. If the subject is declared clinically clear at any of the application visits, they will be placed into follow up. The minimum number of treatments per wart is one and the maximum is 4. They will return at the 12 week point post last visit for final assessment and evaluation.

The Nanopulse System consists of an electrical pulse generator, a handpiece, and a detachable applicator tip at the end of the handpiece that interfaces with the treatment area on the skin. The detachable applicator tip delivers the pulses to the skin through five 3 mm long needle electrodes (27 gauge). The applied electric field, is limited to the space enclosed by the 4 outer electrodes in the applicator tip. An inert, water based gel is applied to the skin and the applicator tip before making contact between subject and applicator tip to ensure that there are no air gaps present between the electrodes through which electrical arcing could occur while pulses are being delivered to the subject. The Applicator Tips are designed for single patient use, and are sterilized prior to first use and between treatment sessions using a standard steam autoclave.

Nanopulse System

Stefani Takahashi, MD

The purpose of this study is to determine if the Nanopulse System can be used to clear common wart lesions on the skin. The Nanopulse System uses a series of low energy, high voltage pulses, each one several billionths of a second in duration, to effectively kill the target tissue contained within the applicator tip electrodes with minimal damage to surrounding tissue. Efficacy and patient outcomes are expected to equal or surpass current treatment modalities in terms of increased ease of use, faster patient healing and minimal scarring with fewer complications resulting from treatment.

The device emits significantly less energy than existing electro-surgery or electro-cautery equipment and is believed to be similar to laser therapy treatment of warts. Trained clinicians can usually diagnose warts based by their appearance and location . Non-genital warts are subcategorized into common, periungual, flat, filiform, and plantar types. Common warts are benign, often skin-colored, or brown-grey, rough, bumpy growths on the hands and feet (caused by Human Papilloma Virus type 2) . Common warts in individuals without any immune deficiencies are low risk and are the focus of this study.Based upon the preclinical profile of the Nanopulse device, particularly its safety profile and its effect on transformed cells, it is hypothesized that application of pulses from the Nanopulse System , will result in complete clinical clearance of Common Wart lesions with minimal scarring.

Study Objective: The objective of this study is to indicate whether the Nanopulse System is efficacious for use in clearing common warts.

The primary objective of this study is to gather lesion clearance data on common warts after application of pulses from the Nanopulse System and determine the optimal number of treatments necessary. Clearance will be measured by clinical observation.

Other objectives of the study include gathering efficacy data on the use of the Nanopulse System for treating common warts in terms of:

1.) Safety in a clinical setting in terms of minimal adverse events over the course of the trial; 2.) Cosmetic results during the healing process and cosmetic outcome; 3.)Effects of 1, 2, 3 or 4 treatments in terms of clearance and cosmetic outcome for each treated wart; 4.)Subject impressions immediately following application of pulses; 5.)Subject satisfaction with the treatment and cosmetic outcome during and following the healing process; 6) Device performance and clinical feedback under actual clinical conditions and to gather information on design features that may be modified to optimize the device.

Nanopulse Efficacy Study for the Treatment of Common Warts

Response rate is defined in each case in terms of no effect (NE=2), partial response (PR=1), or complete response (CR=0). No Effect (NE) would indicate no clinically apparent reduction in lesion size, Partial Response (PR) would indicate a reduction in lesion size, and Complete Response (CR) would indicate no evidence of the lesion detected.

Number of participants who experience an adverse event, regardless of whether they completed the study, will be aggregated through study completion. Both anticipated and unanticipated adverse events will be reported.

Number of participants, regardless of whether they completed the study, who experience serious adverse events will be aggregated through study completion from the clinical report forms and reported at the end of the study.

University of Southern California

Associate Professor, Director

For each adverse event, the details of and circumstances will be recorded at the site and evaluated by the investigator in terms of relatedness, seriousness and the degree to which the event was anticipated.The adverse event will be reported to the sponsor and the Institutional Review Board; and will be followed by study personnel through to its resolution. All unanticipated adverse reactions, regardless of their severity, will be recorded as adverse events and reported to the sponsor.

Nanopulse Treatment

The Nanopulse System consists of an electrical pulse generator, a handpiece, and a detachable applicator tip at the end of the handpiece that interfaces with the treatment area on the skin. The applicator tip delivers pulses to the skin through needle electrodes. The Applicator Tips are designed for single patient use, and are sterilized prior to first use and between treatment sessions using a standard steam autoclave.

All subjects will receive a minimum number of applications per discrete skin wart lesion (n=1 application). Up to 4 warts per subject will be treated. The wart will be debulked prior to the initial application. The subject will return after 1 week for an evaluation visit, at 4 weeks for a second treatment and up to 2 additional monthly treatments. Subjects will be evaluated at each application visit and placed in follow-up when they are declared clinically clear. They will return at the 12 week point post last visit for final assessment and evaluation.

Caucasian (non-Hispanic)

Hispanic Latino

African-American

Asian/SE Islan

Native American

Other

Race/Ethnicity, Customized

Cesar E. Blanco,PhD; Sr Director R&D

Cleared

Partially Removed

No Effect

wart size has been reduced in height and width during treatment.

Partially Removed(1)

The total number of participants who completed the study equals 17. But because one participant had 3 warts that received treated with differing results, they are counted twice (for that participant, one wart cleared and two showed no effect).

Clinical Clearance of Warts

An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

For those anticipated adverse reactions which are not present before the first application procedure and are rated at a severity level above minimal or mild will be recorded at the time of occurrence. The adverse event will be reported to the sponsor, and will be followed by study personnel through to its resolution. All unanticipated adverse reactions, regardless of their severity, will be recorded as adverse events and reported to the sponsor.

Number of Adverse Events

During initial treatment of a wart on a digit, mild pain radiated up the finger from the wart at time of treatment. The pain persisted for 30min. P.O. Tylenol was provided at the time treatment. This did not re-occur during treatments 2,3 and 4.

Total Number of Adverse Events That Occur During the Course of the Study

Number of Serious Adverse Events

Total Number of Serious Adverse Events That Occur During the Course of the Study

The study will be a single center, open label, non-randomized clinical trial that will provide efficacy data for the treatment of common warts by the Nanopulse system in terms of efficacy and cosmetic outcome with 1 - 4 application (treatment) sessions. All subjects will receive a minimum number of applications (n=1 application) per discrete skin wart lesion. Up to 4 warts per subject will be treated with the Nanopulse device. The wart will be debulked to the point of pinpoint bleeding prior to the initial application. The subject will return after 1 week for an evaluation visit and at 4 weeks for a second treatment and 2 additional monthly treatments if warranted. If the subject is declared clinically clear at any of the application visits, they will be placed into follow up. They will return at the 12 week point post last visit for final assessment and evaluation.

Nanopulse System: The Nanopulse System consists of an electrical

David Gordon, MB, ChB

A Phase 3 Open Label Safety Study of A-101 Topical Solution for the Treatment of Common Warts

Safety Study of A-101 Topical Solution for the Treatment of Common Warts

Safety exposure will be measured by the proportion of subjects exposed to A-101 45% who have emergent adverse events. In order to be eligible for A-101-WART-303, subjects must have completed protocol treatment on either the A-101-WART-301 or A-101-WART-302 study. The A-101-WART-303 study was an open-label with a single arm where all subjects received A-101 Topical Solution 45% twice a week. Since A-101-WART-303 is an extension study, statistical analyses were performed by stratifying patients by treatment arms in the A-101-WART-301 or A-101-WART-302 studies. In the A-101-WART-303 study, subjects will be followed every 6 weeks to assess for a recurrence or development of new common warts. If a recurrence occurs or a new wart develops these subjects may return to the site to receive A-101 Topical Solution 45% twice a week for an additional treatment cycle of 8 weeks.

Safety exposure will be measured by the proportion of subjects exposed to A-101 45% who have emergent adverse events. In order to be eligible for A-101-WART-303, subjects must have completed protocol treatment on either the A-101-WART-301 or A-101-WART-302 study. The A-101-WART-303 study was an open-label with a single arm where all subjects received A-101 Topical Solution 45% twice a week. Since A-101-WART-303 is an extension study, statistical analyses were performed by stratifying patients by treatment arms in the A-101-WART-301 or A-101-WART-302 studies.

This endpoint measures the durability of response by time to wart recurrence by prior study treatment group in the Safety Population.

Safety exposure will be measured by the proportion of subjects exposed to A-101 45% who have emergent adverse events. In order to be eligible for A-101-WART-303, subjects must have completed protocol treatment on either the A-101-WART-301 or A-101-WART-302 study. The A-101-WART-303 study was an open-label with a single arm where all subjects received A-101 Topical Solution 45% twice a week. Since A-101-WART-303 is an extension study, statistical analyses were performed by stratifying patients by treatment arms in the A-101-WART-301 or A-101-WART-302 studies.

Efficacy will be assessed using the Physician's Wart Assessment Scale (PWA) which is a 4 point scale. A higher amount of warts cleared represents a better outcome.

Safety exposure will be measured by the proportion of subjects exposed to A-101 45% who have emergent adverse events. In order to be eligible for A-101-WART-303, subjects must have completed protocol treatment on either the A-101-WART-301 or A-101-WART-302 study. The A-101-WART-303 study was an open-label with a single arm where all subjects received A-101 Topical Solution 45% twice a week. Since A-101-WART-303 is an extension study, statistical analyses were performed by stratifying patients by treatment arms in the A-101-WART-301 or A-101-WART-302 studies.

Median time to achieve onset of Clearance (PWA=0) for all treated warts. Efficacy will be assessed using the Physician's Wart Assessment Scale (PWA) which is a 4 point scale. A higher amount of warts cleared represents a better outcome.

Safety exposure will be measured by the proportion of subjects exposed to A-101 45% who have emergent adverse events. In order to be eligible for A-101-WART-303, subjects must have completed protocol treatment on either the A-101-WART-301 or A-101-WART-302 study. The A-101-WART-303 study was an open-label with a single arm where all subjects received A-101 Topical Solution 45% twice a week. Since A-101-WART-303 is an extension study, statistical analyses were performed by stratifying patients by treatment arms in the A-101-WART-301 or A-101-WART-302 studies.

The median was unable to be calculated, so the 25th percentile was used as the time to achieve onset of Clearance (PWA=0) for all treated warts. Efficacy will be assessed using the Physician's Wart Assessment Scale (PWA) which is a 4 point scale. A higher amount of warts cleared represents a better outcome.

In order to be eligible for A-101-WART-303, subjects must have completed protocol treatment on either the A-101-WART-301 or A-101-WART-302 study. The A-101-WART-303 study was an open-label with a single arm where all subjects received A-101 Topical Solution 45% twice a week. Since A-101-WART-303 is an extension study, statistical analyses were performed by stratifying patients by treatment arms in the A-101-WART-301 or A-101-WART-302 studies. However, Baseline Measures were collected as a single arm for the study.

A-101 A-101: Hydrogen Peroxide Topical Solution 45%

A-101 Hydrogen Peroxide Topical Solution 45%

Does the Subject have a Common Wart at Entry to Open-Label Study?

56 subjects did not have a Wart when they entered the open label extension study.

Longest Axis of Largest Wart Treated

A-101 45% (Active)

Isopropyl Alcohol and Water (Vehicle)

The amount of patients in the various treatment cycles differs because patients without wart recurrences or new warts developing may not return for additional treatment cycles.

Proportion of Subjects With Treatment Emergent AEs After Application of A-101 45% for the Treatment of Common Warts

Durability of Response: Median Number of Days All Warts Remain Clear by Treatment Group and Treatment Cycle for Subjects With All Warts Achieving a Status of Clear (PWA=0) (Treatment Cycle 1)

Durability of Response: Median Number of Days All Warts Remain Clear by Treatment Group and Treatment Cycle for Subjects With All Warts Achieving a Status of Clear (PWA=0) (Treatment Cycle 2)

Durability of Response: Median Number of Days All Warts Remain Clear by Treatment Group and Treatment Cycle for Subjects With All Warts Achieving a Status of Clear (PWA=0) (Treatment Cycle 3)

Mean Per-Subject Percent of All Warts That Were Clear on the Physician Wart Assessment (PWA) Scale (Treatment Cycle 1)

Mean Per-Subject Percent of All Warts That Were Clear on the Physician Wart Assessment (PWA) Scale (Treatment Cycle 2)

Mean Per-Subject Percent of All Warts That Were Clear on the Physician Wart Assessment (PWA) Scale (Treatment Cycle 3)

Mean Per-Subject Percent Wart Clearance for Subjects With Single Wart at Baseline by Treatment Group and Treatment Cycle (Treatment Cycle 1)

Mean Per-Subject Percent Wart Clearance for Subjects With Single Wart at Baseline by Treatment Group and Treatment Cycle (Treatment Cycle 2)

Mean Per-Subject Percent Wart Clearance for Subjects With Single Wart at Baseline by Treatment Group and Treatment Cycle (Treatment Cycle 3)

Time to Clearance of All Warts Warts by Treatment Group and Treatment Cycle (Treatment Cycle 1)

Time to Clearance of All Warts Warts by Treatment Group and Treatment Cycle (Treatment Cycle 2)

Time to Clearance of All Warts Warts by Treatment Group and Treatment Cycle (Treatment Cycle 3)

Topical Solution

A-101: hydrogen peroxide topical solution 45%

A-101 Solution 40% administered once per week

A-101 Solution 45% administered once per week

Vehicle Solution administered once per week

A-101 Solution 40

A-101 Solution 45

Vehicle Solution

Stuart D Shanler, MD

This is a randomized, double-blind, vehicle-controlled, parallel-group study with 3 treatment groups.

This is a randomized, double-blind, vehicle-controlled, parallel-group study with 3 treatment groups. During Visit 1, the Investigator will identify 1 eligible common wart on the trunk or extremities on each subject. The wart will be treated up to a maximum of 8 times at 1 week intervals during the study.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Trial of a Botanical Drug Containing East Indian Sandalwood Oil (EISO) for Treatment of Common Warts	NCT01286441	Common Warts	10% EISO Placebo 20% EISO 30% EISO	18 Years -	ViroXis Corporation
Study of A-101 Topical Solution for the Treatment of Common Warts	NCT03687372	Common Wart	A-101 vehicle	2 Years -	Aclaris Therapeutics, Inc.
Carbon Dioxide Laser and Cryotherapy in Treatment of Warts	NCT03166137	Common Warts	Carbon dioxide ... Cryotherapy	-	Assiut University
Nanopulse Efficacy Study for the Treatment of Common Warts	NCT02650466	Common Warts	Nanopulse Syste...	18 Years -	University of Southern California
Safety Study of A-101 Topical Solution for the Treatment of Common Warts	NCT03812510	Common Wart	A-101	1 Year -	Aclaris Therapeutics, Inc.
A Study of A-101 Solution in Subjects With Common Warts.	NCT02669862	Common Warts	A-101 Solution ... A-101 Solution ... Vehicle Solutio...	18 Years -	Aclaris Therapeutics, Inc.
Study With a Topical Gel to Treat Common Warts in Adults	NCT00117871	Warts	Resiquimod	18 Years -	Graceway Pharmaceuticals, LLC
Evaluate the Effectiveness and Safety of DPCP Ointment (Samcyprone™) on the Clearance of Verruca Vulgaris (Common Warts)	NCT02640820	Common Warts HPV (Human Papi... Periungual Wart... Plantar Warts	Sensitizing DPC... Treatment DPCP ...	18 Years - 65 Years	RXi Pharmaceuticals, Corp.
Study With a Topical Gel to Treat Common Warts in Adults	NCT00117871	Warts	Resiquimod	18 Years -	Graceway Pharmaceuticals, LLC
Safety and Efficacy of Varying Regimens of CANDIN for Treatment of Common Warts (Verruca Vulgaris)	NCT02393417	Warts	CANDIN Placebo	18 Years - 65 Years	Nielsen BioSciences, Inc.
Microwave Treatment of Common and Plantar Warts	NCT05371834	Warts	Microwave Treat... Cryotherapy	18 Years - 64 Years	Blackwell Device Consulting
Study With a Topical Gel to Treat Common Warts in Adults	NCT00117923	Warts	Resiquimod	18 Years -	Graceway Pharmaceuticals, LLC

Spots Global Cancer Trial Database for common warts

Every month we try and update this database with for common warts 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.